--Boundary (ID j19WSOBMJM0a0KVa1F0h0A)
Content-type: TEXT/PLAIN; CHARSET=US-ASCII
Subject: Update on Status of PTE-2
To: General Distribution, All Interested
From: Douglas W. Bristol, PTE Project Manager
Note: The body of this e-mail message is also available on the NIEHS server,
accessible through both the WWW and Gopher networks. To go directly to the
PTE2 page on the WWW, use the following address:
<http://www.niehs.nih.gov/dirlecm/pte2.htm>; alternatively, link to it from
the NIEHS Home Page, at: <http://jeeves.niehs.nih.gov/exchange/>. Clarifying
revisions to the PTE2 server page have been submitted and will be installed
within the next few days.
OUTLINE OF CONTENTS:
1. SUMMARY
2. PTE PROJECT RATIONALE
3. CLOSING DATE FOR PARTICIPATION IS EXTENDED
4. NEW GUIDELINES FOR SUBMITTING PREDICTION SETS
5. SOURCES FOR INFORMATION ABOUT NTP-STUDIES
6. REQUEST FOR HELP WITH DISSEMINATION
********************************************************
1. SUMMARY
1.1 This document provides information about the current status of the second,
NIEHS Predictive Toxicology Evaluation (PTE-2) experiment. If you are unable
to receive the entire document, please send an e-mail reply, indicating the
nature of the problem you experienced, or contact us as indicated in Sections
4.1 and 5.2.1. The information will also be distributed by mail and fax to
interested participants, whose e-mail address we do not have.
1.2 Sections 3 and 4 contain important information about current procedures
being applied to the completion of PTE-2, both for potential participants and
for those who have already submitted a manuscript to Environmental Health
Perspectives (EHP). Please feel free to contact us for clarification, for
additional information, or to provide us with your comments and suggestions.
1.3 Many thanks and kudos to Dr. Joe Wachsman, for his outstanding management
and contributions to the PTE project from its inception. Joe shifted his
effort to other research recently, but his knowledge and experience will
continue to be part of PTE-2, as he has agreed to support the project in an
advisory capacity.
2. PTE PROJECT RATIONALE.
2.1 The National Toxicology Program (NTP) conducts standardized chemical
bioassays in rodents, which identify and characterize exposures to substances
that may have carcinogenic or other hazardous effects on human health.
However, more chemicals are already in use than can ever be tested, using
conventional methods. This situation creates an urgent need to develop
reliable predictive models and alternative testing strategies, which identify
hazardous-chemical more rapidly, to support sound, efficient decision-making
in the management of testing or development programs and to accelerate the
performance of risk assessments. The development of such capabilities will
refine and reduce current reliance on the use of large numbers of laboratory
animal for bioassays and may discover factors and relationships for toxicity
pathways and mechanisms that complement information generated by both
bioassays and mechanistic studies. The advantages offered by this field of
research are clear; however, for new hazard-identification models to achieve
their promise, the problem of gaining meaningful estimates of their accuracy
in real-world applications must be solved. The PTE project provides a unique
opportunity to conduct research on the prediction-evaluation problem.
2.2 Begun in 1990 by Tennant et al., the PTE project stimulates strategy
development and fosters research in this new field, by coupling the
development, evaluation, and confirmation of prediction models with ongoing
standardized-bioassay testing performed by the NTP. Specifically it:
1) identifies test-sets of bioassays that serve as common targets for the
development of new hazard-identification models and provide a means for their
rigorous experimental evaluation,
2) provides NTP test-result information and test-chemical samples to the
research community,
3) encourages involvement of researchers from diverse disciplines, to promote
the application of a wide range of alternative approaches to solving this
difficult problem and to maximize the yield of what can be learned from the
comparative-evaluation experiments,
4) disseminates information about the predictions generated through the
publication of manuscripts and conduct of conferences.
2.3 Thus, the PTE project is an ongoing, international, cross-disciplinary
experiment, conducted openly to evaluate and confirm the performance of
predictive-toxicology methods. It provides objective estimates of true
performance and creates unique opportunities for the scientific community to
evaluate the strengths and weaknesses of various predictive-toxicology models
and approaches. In addition, because each published prediction is a new
hypotheses about the outcome of a bioassay, the PTE project increases the
yield of information and the overall value of each standardized,
chemical-carcinogenesis bioassay that is conducted.
3. CLOSING DATE FOR PARTICIPATION IS EXTENDED
3.1 For predictions to be truly prospective, they must be documented prior to
bioassay completion and a closing date of December 31, 1995 was originally
established for their submission. Although the best information available in
late 1993 was used to set the closing date, NTP Technical Reports for 9 of the
30 bioassays in PTE-2 reached peer review before then; 4 in June and 5 in
December, 1995. The 9 are identified by the table in Section 3.4. Thus,
vagaries associated with projecting bioassay completion dates precluded the
absolute attainment of this goal. The evaluation of all prediction sets are
affected, because none were generated before the June 1995 peer review.
Furthermore, all but 2 sets of predictions, which were submitted before the
December, 1995 peer review, are affected by the 9 bioassays that were
completed early.
3.2 A second independent variable, associated with the December 31, 1995
closing date, has had a negative impact on the goal of achieving maximum
participation in PTE-2. The furloughs imposed on federal-government employees
during November and December of 1995, blocked the timely submission of
prediction papers by several research groups who intended to participate.
3.3 Early completion of 9 bioassays complicates evaluation of the overall
results from the PTE-2 experiment, but the exact nature and magnitude of
effects that may have been introduced cannot be determined until the
experiment is completed. Theoretically, the impact that an effect can have on
our collective ability to evaluate results is proportionate to the extent to
which a model is based on various kinds of human-expert knowledge; conversely,
models that are based exclusively on machine-learning may be immune to such
confounding effects. Also, the early completion has no effect on evaluation
of the predictions made for 21 of the 30 bioassays in PTE-2. We expect that
standard analysis techniques will be able to identify obvious confounding
effects that may have been introduced and, to support such impact analysis, we
will maintain and make public a log that documents the submission or revision
of all predictions in manuscripts that we receive.
3.4 Test articles for the 30, NTP, chemical-carcinogenicity bioassays that
constitute PTE-2 are tabulated below, along with the dates on which Technical
Reports (TR) were peer reviewed for the 9 bioassays that have been completed.
This table is also enclosed as Attachment 1, in 2 formats: Microsoft Word 5.1
(wrd) or text-only with line breaks (txt).
Table 1. Test-Articles and Completion Status for 30 Carcinogenesis Bioassays
that Constitute the Second, NIEHS Predictive-Toxicology Evaluation Experiment.
PTE-2 # Test-Article Name CASRN MSR Ref* or TR # TR Rev Date**
1. anthraquinone 84-65-1 7
2. chloroprene 126-99-8 10 12/11/96
3. 1-chloro-2-propanol 127-00-4 10
4. cinnamaldehyde 104-55-2 5
5. citral 5392-40-5 5
6. cobalt sulfate heptahydrate 10026-24-1 10 12/11/96
7. codeine 76-57-3 455 06/21/95
8. D&C Yellow No. 11 8003-22-3 463 12/05/95
9. diethanolamine 111-42-2 11
10. 1,2-dihydro-2,2,4-trimethylquinoline 147-47-7 456 06/21/95
11. Emodin 518-82-1 7
12. ethylbenzene 100-41-4 11 12/11/96
13. ethylene glycol monobutyl ether 111-76-2 8
14. furfuryl alcohol 98-00-0 10
15. gallium arsenide 1303-00-0 8
16. isobutene 115-11-7 10
17. isobutyraldehyde 78-84-2 10 12/11/96
18. methyleugenol 93-15-2 7
19. molybdenum trioxide 1313-27-5 462 12/05/95
20. nitromethane 75-52-5 461 12/05/95
21. oxymetholone 434-07-1 7
22. phenolphthalein 77-09-8 465 12/05/95
23. primaclone 125-33-7 10 12/11/96
24. pyridine 110-86-1 10
25. scopolamine hydrobromide trihydrate 6533-68-2 445 06/21/95
26. sodium nitrite 7632-00-0 7
27. sodium xylenesulfonate 1300-72-7 464 12/05/95
28. t-butylhydroquinone 1948-33-0 459 06/21/95
29. tetrahydrofuran 109-99-9 10 12/11/96
30. vanadium pentoxide 1314-62-1 4
*The Management Status Report Reference number indicates progress towards
completion of each bioassay.
**NB: The Next peer review of NTP Technical Reports (TR) has been scheduled
for December 11-12, 1996.
3.5 The primary purpose for conducting or participating in a
predictive-toxicology evaluation experiment of any kind is to learn. While
early completion for 9 of NTP bioassay studies in PTE-2 is unfortunate, the
overall learning potential of the evaluation experiment is influenced more by
the number and variety of prediction models involved. Therefore, it is
vitally important that as many predictors participate as possible. Therefore,
to enhance achievement of the goal for maximum participation in PTE-2, we have
extended the closing date for the submission of prediction papers for PTE-2 to
May 15, 1996. This revised date for submission of manuscripts reflects a
compromise between knowledge that the next peer review of NTP Technical
Reports will not be conducted before December 11-12, 1996 and finding a new
submission closing date that fits within the constraints imposed by the
long-range publication schedule that EHP operates under.
4. NEW GUIDELINES FOR SUBMITTING PREDICTION SETS
4.1 Manuscripts should be submitted for peer review and publication to the
NIEHS journal, Environmental Health Perspectives, or to any other
high-quality, peer-reviewed journal. IN ADDITION, A COPY OF THE SUBMISSION
SHOULD BE SENT TO MR. ARNOLD GREENWELL AT THE FOLLOWING ADDRESS:
Mr. Arnold Greenwell
NIH/NIEHS, B3-09
PO Box 12233
Research Triangle Park, NC 27709
greenwell at niehs.nih.gov
Tel: 919.541.3393
FAX: 919-541-1460
4.2 EHP Editors have indicated that PTE-2 manuscripts already submitted, plus
those received by May 15, 1996, will be published together as a special EHP
Supplement during November, 1996. Prospective authors are always welcome to
submit prediction manuscripts to EHP, but should realize that prediction
papers submitted after May 15, will not be eligible for inclusion in the
November Supplement and that, as a general policy, EHP will publish only
papers that are found to be acceptable after peer-review and contain merit
relative to manuscripts submitted on other research topics.
4.3 Participants who have not yet made a submission are invited to present
their predictions in a format that includes: a description of the methodology
upon which the model is based; a prediction for the outcome of each
sex-species experiment; a prediction for the overall chemical bioassay; the
rationale supporting each prediction; and some indication of potency for each
bioassay experiment that is predicted to be positive, using any preferred
definition for potency.
4.4 Participants who have already submitted a manuscript are welcome to
utilize the time made available by the extension of PTE-2, to perform
additional research. However, EHP will only consider new manuscripts for
inclusion in the Supplement when they present significant new methods,
findings, or insights. The May 15, 1996 closing date also applies. Further
information about the submission of manuscripts for inclusion in the EHP
Supplement is available from Dr. Tom Goehl, Editor, EHP; 919.541.79619 (v);
919.541.0273 (fax); e-mail: goehl at niehs.nih.gov.
5. SOURCES FOR INFORMATION ABOUT NTP-STUDIES
5.1 Attachment 2 (as both txt and wrd formats in the enclosure).provides procedures
about how to access information about all aspects of the NTP, by mail,
telephone, fax machine, and using electronic communication via the World Wide
Web (WWW).
5.2 Distribution of Information Compiled for PTE-2 and Test-Chemical Samples.
5.2.1 Dr. Joe Wachsman prepared a broad-based summary of toxicity information
that may be relevant to predicting the outcome for each of the 30
chemical-carcinogenesis bioassays in PTE-2. This document outlines the
results available by the end of 1994 from mutagenicity tests, 90-day
subchronic pathology studies, and other, relatively short-term toxicity tests
conducted by the NTP, along with information gleaned from literature searches.
Dr. Wachsman's document is included in the enclosure as Attachment 3 (both
wrd and txt formats); its size precluded inclusion in the body of this e-mail
message. If you are not able to open this document from the enclosure, but
would like to receive it, please contact Arnold Greenwell; however, for access
on the computer Internet to current information about NTP-study results, see
Section 5.3.
5.2.2 Participants, whose approach to making predictions requires
experimental measurement, can request samples of each test chemical by
contacting Arnold Greenwell.
5.3 The recently developed NIEHS and NTP Internet servers are the result of an
extensive and highly successful effort by NTP staff. These servers make
current information about the status and results of NTP studies available to
the public in electronic form via the Internet. If you have access to the
Internet, please review Attachment 2 in the enclosure and try the following
electronic sources of information to see if they provide what you need. The
Internet addresses (as of 1/22/96) for the NIEHS- and NTP-Servers that I find
useful include:
5.3.1. NIEHS Home Page: http://www.niehs.nih.gov/
5.3.2. NTP Home Page: http://ntp-server.niehs.nih.gov/
5.3.3. NTP RESOURCES PAGE:
http://ntp-server.niehs.nih.gov/Main_Pages/NTP_PG1.html (address subject to
change)
5.3.3.1. NTP Study Information:
http://ntp-server.niehs.nih.gov/Main_Pages/NTP_ALL_STDY_PG.html (address
subject to change)
5.3.3.1.1 Status of All Chemicals Selected for Study (search capability
provides access to virtually all NTP studies):
http://ntp-server.niehs.nih.gov/Main_Pages/NTP_STATUS_PG.html (address subject
to change)
5.3.3.1.2 NTP Priority-Chemical Page:
http://ntp-server.niehs.nih.gov/Main_Pages/NTP_CHEM_PG.html (address subject
to change)
5.3.4. NTP Prechronic Histopathology, added on 12/14/95:
http://ntp-support.niehs.nih.gov/htdocs/Prechron_path.html (address subject to
change)
5.3.5. NTP Gopher Menu: gopher://ntp-ftp-server.niehs.nih.gov/
NB: A computer scientist who helped develop the servers advised that most
users will find the "ntp-server" to be better than the
"gopher//ntp-ftp-server", because the "ntp-server" was designed and developed
to take advantage of more recent web technology." Although the server is
mounted on a MAC system, both the gopher and web applications are independent
of the client's platform.
6. REQUEST FOR HELP WITH DISSEMINATION
This information is being sent to individuals who have expressed their
interest in PTE-2 to us. However, our ultimate goal is to bring this
information to the attention of all parties that may have any interest in
PTE-2, so as to create the opportunity for them to consider participating in
the PTE-2 project. Thus we ask and encourage those who receive this update
for PTE-2, to share it openly by passing it on to others who may be receptive
to the information it conveys. Your help with the dissemination of this
information, will ensure a high level of participation in PTE-2 and increase
the overall yield of information that can be achieved. Thank you.
Dr. Douglas W. Bristol
Lab of Environ Carcinogenesis and Mutagenesis
NIH/NIEHS, B3-09
PO Box 12233
Research Triangle Park, NC 27709
e-mail: bristol at niehs.nih.gov
Tel: 919.541.2756
FAX: 919-541-1460
===============================================================
<<<<<< Attached TEXT file named "Attch1.txt" follows >>>>>>
ATTACHMENT 1.txt
Table 1. Test-Articles and Completion Status for 30 Carcinogenesis Bioassays
that Constitute the
Second, NIEHS Predictive-Toxicology Evaluation Experiment.
PTE-2 No.
Test-Article Name
CASRN
MSR Ref* or TR No.
TR Rev. Date**
1.
anthraquinone
84-65-1
7
2.
chloroprene
126-99-8
10
12/11/96
3.
1-chloro-2-propanol
127-00-4
10
4.
cinnamaldehyde
104-55-2
5
5.
citral
5392-40-5
5
6.
cobalt sulfate heptahydrate
10026-24-1
10
12/11/96
7.
codeine
76-57-3
455
06/21/95
8.
D&C Yellow No. 11
8003-22-3
463
12/05/95
9.
diethanolamine
111-42-2
11
10.
1,2-dihydro-2,2,4-trimethylquinoline
147-47-7
456
06/21/95
11.
Emodin
518-82-1
7
12.
ethylbenzene
100-41-4
11
12/11/96
13.
ethylene glycol monobutyl ether
111-76-2
8
14.
furfuryl alcohol
98-00-0
10
15.
gallium arsenide
1303-00-0
8
16.
isobutene
115-11-7
10
17.
isobutyraldehyde
78-84-2
10
12/11/96
18.
methyleugenol
93-15-2
7
19.
molybdenum trioxide
1313-27-5
462
12/05/95
20.
nitromethane
75-52-5
461
12/05/95
21.
oxymetholone
434-07-1
7
22.
phenolphthalein
77-09-8
465
12/05/95
23.
primaclone
125-33-7
10
12/11/96
24.
pyridine
110-86-1
10
25.
scopolamine hydrobromide trihydrate
6533-68-2
445
06/21/95
26.
sodium nitrite
7632-00-0
7
27.
sodium xylenesulfonate
1300-72-7
464
12/05/95
28.
t-butylhydroquinone
1948-33-0
459
06/21/95
29.
tetrahydrofuran
109-99-9
10
12/11/96
30.
vanadium pentoxide
1314-62-1
4
*The Management Status Report Reference number indicates progress towards
completion of each
bioassay.
**NB: The Next peer review of NTP Technical Reports (TR) has been scheduled
for December11-12,
1996. To foster maximum participation in PTE-2, the closing date for the
submission of prediction
papers has been extended to May 15, 1996.
<<<<<< Attached TEXT file named "Attch2.txt" follows >>>>>>
ATTACHMENT 2.txt
TWO WAYS TO OBTAIN INFORMATION FROM THE NTP
1. New Access Using Electronic Communication Via the World Wide Web
In addition to contacting the NIEHS by letter or telephone, the Institute
makes available selected
NIEHS and NTP information in electronic format world-wide. For example, the
NTP Annual
Plan, Annual Report on Carcinogens (Summary), Abstracts of NTP Reports, and
the Status of All
NTP Studies are all available on the NIEHS Gopher Client Server. Between
August 1994 and
July 1995 more than 100,000 accesses of the NTP information have been
performed over the
internet from the NIEHS Gopher Server. In the summer of 1995 an NTP World
Wide Web
(www) server was established. The www format allows a wider variety of ways
to display
information e.g., graphics, tables, sound, action video, and permits links,
which take a client from
one document to other sources thatmay be either on the same server or any
other web server. In
the short time that the NTP Web server has been operational the access to
this server has
approached 10,000 accesses per month from 600-800 unique sites located
throughout the world.
.This is in addition to the 8-9000 accesses per month via the NIEHS Gopher
System.
To view this information requires access to the Internet through a software
client, such as Netscape
Navigator, Gopher, or Mosaic. The World Wide Web and Gopher servers are
located at NIEHS.
To access the NTP World Wide Web Homepage, use the URL:
http://ntp-server.niehs.nih.gov/ .
The address for gaining access the NIEHS Gopher Server is:
Gopher.niehs.nih.gov .
For more information, contact Dr. W. Eastin, Environmental Toxicology Program,
NIEHS
e-mail address: eastin at niehs.nih.gov
2. Access Using Conventional Means.
The National Toxicology Program (NTP) generates and archives information and
results on
Carcinogenesis, Short-term Toxicity, Reproductive Assessment by Continuous
Breeding,
Teratology, Immunology, Neurotoxicity, Genetic toxicity, Chemical Disposition
and Toxicokinetic
research conducted on chemicals nominated for study. Chemical-related
information is submitted
to NIEHS from a variety of sources including contract laboratories, in-house
studies and
committee meetings. This information is archived and maintained in a central
location (Central
Files) so that all chemical-related study information can be monitored and
tracked efficiently.
Currently, more than 800 chemical studies are on file. Chemical-related study
information in these
Central Files is maintained by Central Data Management (CDM) staff. NTP
Information is
routinely provided to industry and the public on an as requested basis. From
August 1, 1994 until
July 31, 1995, about 8000 requests for information from outside NIEHS were
filled and more than
2300 requests from within the NTP were filled. Examples of the information
available include the
Management Status Report which lists the study status of short- and long-term
toxicity studies and
the NTP Annual Plan, which describes the accomplishments and future study
plans. The
Management Status Report is sent out quarterly to more than 4000 people. In
addition, CDM
maintains a mailing list for the following NTP documents:
o NTP Annual Plan (including Review of Current DHHS, DOE, and EPA Research
Related to
Toxicology);
o Technical Reports on NTP toxicology and carcinogenesis studies and
short-term toxicity studies;
o Annual Report on Carcinogens and Biennial Report on Carcinogens, prepared
for the Secretary
of DHHS;
o Management Status Report, produced from the NTP CHEMTRACK system;
o Summary minutes of the NTP Board of Scientific Counselors' and Technical
Reports Review
Subcommittee meetings.
To request specific information or to be added to the mailing list for
publications listed above,
contact CDM by one of the following:
Central Data Management
National Institute of Environmental Health Sciences
P.O. Box 12233
Mail Drop A0-01
Research Triangle Park, NC 27709
FAX number: (919) 541-4714
Telephone number: (919) 541-3419
Internet e-mail Address: CDM at NIEHS.NIH.GOV.
<<<<<< Attached TEXT file named "Attch3.txt" follows >>>>>>
ATTACHMENT 3.txt
STRATEGIES FOR PREDICTING CHEMICAL
CARCINOGENESIS IN RODENTS
Second Round of Predictions With Completion Deadline of
December 31,1995 1
90-Day Subchronic Pathology
Related Information 2
There are uncertainties about the Peer Review dates for the 2-year chronic
studies.
However, the sequence of Peer Review will follow the numerical order of the 30
chemicals
discussed in this report.
1 Revised 2/14/96 to extend submission completion date to May 15, 1996.
Also, order in
which information is presented was rearranged to coincide with current numbers
assigned
to the 30 bioassays in PTE-2.
2 Represents the scientific interests and personal choices of J.T. Wachsman,
Ph.D.,
Program Coordinator
1. Anthraquinone
90-Day Subchronic Dosed Feed Study
Start date of 1/94
Related Information:
Studies with substituted anthraquinones indicate that liver, kidney, and
urinary bladder are
the primary target organs in rats. Feed studies sponsored by the National
Cancer Institute
showed that 2-Aminoanthraquinone (CAS No. 117-79-3; Technical Report No. 144
(1978), 2-Methyl-1-Nitroanthraquinone (CAS No. 129-15-7; Technical Report No.
29
(1978); 1-Amino-2-Methylanthraquinone (CAS No. 82-28-0; Technical Report No.
111
(1978) were carcinogenic in rats and mice.
2. Chloroprene
90-Day Subchronic Inhalation Study
Rats: Animals exposed to 80 and 200 ppm showed minimal to moderate lesions of
the nasal
mucosa; degeneration and respiratory metaplasia of the olfactory epithelium
and
suppurative inflammation of the nasal turbinates. In animals exposed to 200
ppm,
hepatic lesions, including randomly distributed necrosis and hemosiderosis was
observed.
Mice: At the 80 ppm level, minimal to slight forestomach hyperplasia was
observed.
Related Information:
Chloroprene is structurally related to 1,3-butadiene. The latter chemical has
been reported
to be carcinogenic in Sprague-Dawley rats [P.E. Owen, J.R. Glaister, I. F.
Gaunt and
D.H. Pullinger. Inhalation toxicity studies with 1,3-butadiene. Two year
toxicity/carcinogenicity study in rats. Am. Ind. Hyg. Assoc. J. 48 (1987)
407-413] and in
mice [NTP Technical Report No. 434 (1993)].
In a study involving the exposure of Wistar rats to a maximum dose of
chloroprene at 50
ppm, it was concluded that there was no evidence of carcinogenic activity
[P.G.J. Reuzel,
M.C. Bosland, H.C. Van-der Meulen, and V.J. Feron. A 2-year inhalation
carcinogenicity
study of chloroprene in rats. Report R 6077. Centraal Instituut Voor
Voedingsonderzoek,
Zeist, The Netherlands (1980)].
3. 1-Chloro-2-Propanol
90-Day Subchronic Inhalation Study
Rats: Pancreatic acinar cell degeneration and pancreatic fatty changes were
seen in both males
and females. In addition, the presence of hepatic cytoplasmic vacuolization
was observed
in males while renal tubular regeneration was shown in females.
Mice: Pancreatic lesions similar to, but less severe than those seen in rats,
were observed.
Related Information:
Strain A mice given 1-chloro-2-propanol i.p. did not show an increase in
surface adenomas
of the lung. J.C. Theiss, M.B. Shimkin, and L.A. Poirier. Introduction of
pulmonary
adenomas in strain A mice by substituted organohalides. Cancer Res. 39 (1979)
391-395.
2-Chloropropanol has been reported to be tumorigenic for Swiss mice by
subcutaneous
injection and by intragastric intubation. B.L. Van Duuren, B.M. Goldschmidt,
G.
Loewengart, A.C. Smith, S. Melchionne, I. Seldman, and D. Roth.
Carcinogenicity of
halogenated olefinic and aliphatic hydrocarbons in mice. J. Natl. Cancer
Inst. 63 (1979)
1433-1439.
4. Cinnamaldehyde
90-Day Subchronic Study, Microencapsulation in Feed (Start date of 7/95)
Related Information:
C.D. Hebert, J. Yuan, and M.P. Dieter. Comparison of the toxicity of
cinnamaldehyde
when administered by microencapsulation in feed or by corn oil gavage. Fd.
Chem.
Toxicol. (1994) in press.
Rats and mice of both sexes received cinnamaldehyde by daily corn oil gavage
(for 2
weeks) or in a microencapsulated form in feed (2 weeks for rats, 3 weeks for
mice).
Chemical administration by either route caused hyperplasia of the forestomach
mucosa in
both sexes of both species. In addition, administration by microencapsulation
resulted in
hypoplasia of the following:
Rat: seminal vesicle, prostate and testis, uterus and ovary
Mouse: uterus
Cinnamaldehyde is antimutagenic for both E. coli and mammalian cells. T.
Ohta, K.
Watanabe, M. Moriya, Y. Shirasu, and T. Kada. Analysis of the antimutagenic
effect of
cinnamaldehyde on chemically induced mutagenesis in Escherichia coli. Mol.
Gen. Genet.
192 (1983) 309-315. H. Imanishi, Y.F. Sasaki, K. Matsumoto, M. Watanabe, T.
Ohta,
Y. Shirasu, and K. Tutikawa. Suppression of 6-TG-resistant mutations in V79
cells and
recessive spot formations in mice by vanillin. Mutation Res. 243 (1990)
151-158.
5. Citral
14-Day Subchronic Study, Microencapsulation in Feed
Rats: Showed minimal to mild hyperplasia and/or squamous metaplasia of
anterior nasal
respiratory epithelium.
Mice: No histopathological changes found.
90-Day Subchronic Studies, scheduled to begin in 1995.
Related Information:
A 14-day gavage study was performed at the same time as the 14-day
microencapsulation
study. M.P. Dieter, T.J. Goehl, C.W. Jameson, M.R. Elwell, P.K. Hildebrandt,
and
J.H. Yuan. Comparison of the toxicity of citral in F344 rats and B6C3F1 mice
when
administered by microencapsulation in feed or by corn-oil gavage. Fd. Chem.
Toxic. 31
(1993) 463-474. In the gavage study, male rats showed only minimal
hyperplasia of
forestomach squamous epithelium. Cytoplasmic vacuolization of hepatocytes
occurred in
mice of both sexes, as well as necrosis, ulceration and/or acute inflammation
of the
forestomach.
Citral has estrogenic activity. A.A. Geldof, C. Engel, and B.R. Rao.
Estrogenic action of
commonly used fragrant agent citral induces prostatic hyperplasia. Urol. Res.
20 (1992)
139-144.
Citral inhibits the formation of retinoic acid from retinol in mouse
epidermis. M.J.
Connor. Modulation of tumor promotion in mouse skin by the food additive
citral (3,7-
dimethyl-2,6-octadienal). Cancer Lett. 56 (1991) 25-28.
M. Sandbank, A. Abramovici, R. Wolf, and E.B. David. Sebaceous gland
hyperplasia
following topical application of citral. An ultrastructural study. Amer. J.
Dermatopath. 10
(1988) 415-418.
In NTP sponsored gavage studies, geranyl acetate (CAS No. 105-87-3), a related
chemical, was found to be non-carcinogenic for either rats or mice. Technical
Report No.
252 (1987).
6. Cobalt Sulfate Heptahydrate
90-Day Subchronic Inhalation Study
Rats: Male and female animals showed proliferation, inflammatory, and
metaplastic changes in
the larynx; proliferative and inflammatory changes in the lung; inflammatory,
degenerative, and metaplastic changes in the nasal cavity.
Mice: Male and female mace showed inflammatory and metaplastic changes in the
larynx;
inflammatory and proliferative changes in the lung; inflammatory, degenerative
and
metaplastic changes in the nasal cavity; lymphoid hyperplasia in the
mediastinal lymph
node; metaplastic changes in the trachea. Degeneration of the testes was also
seen.
For both rats and mice, the most sensitive tissue was the larynx, with
squamous
metaplasia observed at concentrations of chemical as low as 0.3 mg/m3.
Related Information:
Cobaltous chloride has been found to be antimutagenic in E. coli [Y. Kuroda
and T. Inoue.
Antimutagenesis by factors affecting DNA repair in bacteria. Mutation Res.
202 (1988)
387-391.] and in cultured mammalian cells [Y. Kuroda, A.K. Jain, H. Tezuka,
and T.
Kada. Antimutagenicity in cultured mammalian cells. Mutation Res. 267
(1992) 201-
209].
7. Codeine
90-Day Subchronic Dosed-Feed Study
At doses up to 6250 ppm (average of 245 mg/kg/day for rats and 693 mg/kg/day
for
mice), no histopathological effects related to codeine administered were found
for either
rats or mice.
Related Information:
J. Yuan, J.K. Dunnick, E.R. Barnes, and J.W.A. Findlay. Codeine
toxicokinetics in rats
during a two-year dosed feed study. Drug. Metab. Dispos. 22 (1994) 14-20.
8. D&C Yellow No. 11
90-Day Subchronic Study, Dosed-Feed
Rats: Male and female animals showed pigment accumulation in both the liver
and kidneys. In
male rats, the pigment in renal tubules was associated with hyaline
droplet-like structures.
Periportal hepatocyte degeneration was observed in both sexes at 5.0% dosed
feed, and
in males at 1.7%.
Mice: Pigment accumulation was shown in the liver. Degeneration of periportal
hepatocytes
was detected in both sexes given 5.0% or 1.7% dye, and in some males given
0.50%
dye.
Related Information:
Since the FDA has only required rat data for other D&C dyes, it was decided to
restrict the
2-year chronic study to F344 rats.
9. Diethanolamine
90-Day Subchronic Study, Skin Painting
Rats: The skin lesions characterized include ulcers, hyperkeratoses,
acanthosis, and
inflammation. The kidney showed nephropathy, tubular epithelial necrosis, and
tubular
mineralization. Demyelination of brain was also observed.
Mice: Skin lesions characterized as ulcers, hyperkeratoses, acanthoses, and
inflammation were
seen. Cytological alteration and hepatocyte necrosis of the liver, necrosis
of kidney
tubular epithelium, heart degeneration, as well as lymphoid depletion of the
spleen,
thymus, and lymph nodes was observed. Cortical congestion of the adrenal
gland,
cytological alteration of the salivary gland, and cytoplasmic alteration of
the pancreas
were also demonstrated.
Related Information:
In an NTP sponsored study (Toxicity Report No. 20, 1992), no skin lesions were
found in
a 90-day subchronic dosed water study involving rats or mice. Otherwise, mice
exhibited
the same pathology as that found in the skin painting study. Rats, in
addition to similar
kidney and brain pathology as that found in the skin painting study, showed
lesions in the
epididymis, seminal vesicle, prostate gland, thymus, and adrenal cortex.
Diethanolamine, in the presence of nitrite or oxides of nitrogen, may be
nitrosated to N-
nitrosodiethanolamine, a potent liver and nasal carcinogen in rats [W.
Lijinsky, M.D.
Reuber, and W.B. Manning].
Potent carcinogenicity of nitrosodiethanolamine in rats. Nature 288 (1980)
589-590. R.
Preussmann, M. Habs, H. Habs, and D. Schmahl. Carcinogenicity of N-
nitrosodiethanolamine in rats at five different dose levels [Cancer Res. 42
(1982) 5167-
5171].
10. 1,2-Dihydro-2,2,4-Trimethylquinoline (Monomer)
90-Day Subchronic Study, Skin Painting
Rats: Skin lesions consisting primarily of acanthoses and hyperkeratoses were
observed at the
100 and 200 mg/kg dose levels in both sexes. Male rats exposed to the 200
mg/kg dose
level showed vacuolization of hepatocellular cytoplasm of cells distributed
around
periportal or mid-zonal areas.
Mice: Skin lesions consisting primarily of acanthoses and hyperkeratoses were
found at the 100
and 200 mg/kg dose levels in both sexes. In addition, dermal inflammation and
fibroses
were shown in both sexes at dose levels of 10-50 mg/kg.
Related Information:
Y.M. Ioannou, L.T. Burka, J.M. Sanders, M.P. Moorman, and H.B. Matthews.
Absorption,
distribution, metabolism, and excretion of
1,2-dihydro-2,2,4-trimethylquinoline in the male
F344 rat. Drug Metab. Dispos. 15 (1987) 367-373.
11. Emodin
90-Day Subchronic Study, Dosed-Feed
Rats: Males and females showed an increased formation of hyaline droplets in
the cytoplasm of
kidney cortical epithelial cells; the presence of orange-brown pigment
deposits,
considered to be emodin or one of its metabolites, was also observed.
Mice: Both sexes showed nephropathy characterized by focal areas principally
involving the
cortex, where the tubular epithelium was either flattened or hyperplastic;
this was
accompanied by thickened basement membranes and interstitial fibrosis.
Brownish-red
to black pigment deposits were observed in renal cortical and collecting
tubules.
Related Information:
D. Wolfle, C. Schmutte, J. Westendorf, and H. Marquardt.
Hydroxyanthraquinones as
tumor promoters: enhancement of malignant transformation of C3H mouse
fibroblasts and
growth stimulation of primary rat hepatocytes. Cancer Res. 50 (1990)
6540-6544.
12. Ethylbenzene
90-Day Subchronic Inhalation Study
No chemically related lesions were found in either rats or mice exposed to
concentrations
as high as 1000 ppm (0.10%).
Related Information:
Exposure of Sprague-Dawley rats to ethylbenzene (500 mg/kg) by gavage has been
reported to increase the incidence of tumor formation. [C. Maltoni, B. Conti,
G. Conti,
and F. Belpoggi. Experimental studies in benzene carcinogenicity at the
Bologna Institute
of Oncology: current results ongoing research. Am. J. Ind. Med. 7 (1985)
415-446.]
13. Ethylene Glycol Monobutyl Ether (2-Butoxyethanol)
90-Day Subchronic Inhalation Study
Rats: Animals showed a chemical related mild to moderate regenerative anemia
as well as
hepatic lesions (hemosiderin accumulation in Kupffer cells, liver necrosis,
and
centrilobular hepatocellular degeneration). Other observed abnormalities
include
excessive splenic extramedullary hematopoiesis, renal tubule degeneration and
hemosiderin deposition, and bone marrow hyperplasia.
Mice: Animals showed a chemical related moderate regenerative anemia with an
increased
platelet count. Other observed abnormalities consisted of excessive splenic
extramedullary hematopoiesis and hemosiderosis, hemosiderin accumulation in
Kupffer
cells, renal tubular degeneration and hemosiderin deposition, and testicular
degeneration.
Also noted were forestomach necrosis, ulceration, inflammation and epithelial
hyperplasia with a presumed secondary pleuritis and peritonitis.
14. Furfuryl Alcohol
90-Day Subchronic Inhalation Study
Rats: Lesions in the nose consisted of squamous metaplasia and goblet cell
hyperplasia of the
respiratory epithelium; squamous metaplasia of the cuboidal epithelium;
epithelial
hypertrophy of the nasopharyngeal duct; degeneration, surface exudate
hyperplasia and
metaplasia of the olfactory epithelium; mixed cell inflammation of the lamina
propria
lining nasal passages.
Mice: Lesions in the nose consisted of metaplasia, degeneration and chronic inflammation
of the
olfactory epithelium; intracytoplasmic eosinophilic hyaline droplets within
the respiratory
epithelium; ductal ectasia of the submucosal septal glands.
Related Information:
The NTP has completed 2 year carcinogenicity studies on two related compounds;
furan
(Technical Report No. 402) and furfural (Technical Report No. 382). Both
chemicals were
administered by corn oil gavage. Furan was responsible for the formation of
cholangiocarcinomas in rats and hepatocellular carcinomas in mice. Furfural
was the
etiological agent for both cholangiocarcinomas and liver dysplasia with
fibrosis in rats, as
well as for hepatocellular neoplasms in mice.
In 1981, the NTP conducted a 90-day subchronic toxicity study of furfural
alcohol
administered by gavage in corn oil. Mild histopathologic liver lesions
(congestion and
degeneration) were found in rats receiving 150 and 300 mg/kg doses. Mice
receiving a 300
mg/kg dose showed kidney lesions (minimal to moderate necrosis and mild to
marked
cytoplasmic vacuolization of tubular epithelial cells); liver lesions (zonal
necrosis and
minimal to mild cytoplasmic vacuolization); mild to marked necrosis of
lymphoid tissue in
the thymus was frequently accompanied by mild to marked atrophy of the spleen.
No
significant lesions were observed in the kidneys and liver of mice in the 150
mg/kg dose
group.
15. Gallium Arsenide
90-Day Subchronic Inhalation Study
Rats: Exposure to the chemical was associated with regenerative anemia,
pulmonary
inflammatory lesions, tracheobronchial lymph node hyperplasia, laryngeal
squamous
metaplasia. The following was found only in males: inflammatory response in
blood,
bone marrow hyperplasia, and testicular atrophy.
Mice: Exposure to the chemical was associated with regenerative anemia,
inflammatory
response in blood, pulmonary alveolar hyperplasia and inflammatory lesions,
laryngeal
squamous metaplasia, hemosiderosis in spleen and liver, and testicular
atrophy.
16. Isobutene
90-Day Subchronic Inhalation Study
Rats: Except for nasopharyngeal duct goblet cell hypertrophy, which was
somewhat related to
chemical exposure, histopathological lesions were not observed at exposures up
to a
maximum of 8000 ppm.
Mice: No histopathological lesions were observed at exposures up to a maximum
of 8000 ppm.
Related Information:
In a 2-year inhalation study sponsored by the NTP, there was no evidence that
propylene
was carcinogenic for rats or mice. NTP 1985 Technical Report No. 272.
The epoxide of isobutene has been found to be mutagenic in Salmonella, in
contrast to
isobutene, which is non-mutagenic. M. Cornet, P. Castelain, A. Vercruysse, R.
Laib, M.
Kirsch-Volders and V. Rogiers. Mutagenicity of 2-methylpropene (isobutene)
and its
epoxide in a modified Salmonella assay for volatile compounds. Mutation Res.
271 (1992)
213-221.
Isobutene is structurally similar for 1,3-butadiene. In a chronic inhalation
study of 1,3-
butadiene sponsored by the NTP, there was clear evidence of carcinogenicity in
both male
and female mice. NTP Technical Report No. 434 (1993).
17. Isobutyraldehyde
90-Day Subchronic Inhalation Study
Rats: This chemical causes upper respiratory lesions (necrosis, acute
inflammation, epithelial
degeneration, regeneration, and (or) metaplasia) in the nasal mucosa and bone
marrow,
larynx and trachea. Lymphoid necrosis and lymphoid depletion was seen in the
spleen.
Testicular degeneration was observed as well as osteodystrophy of turbinate
bones. The
estimated no observable effect level for males and females was 500 ppm and
1000 ppm,
respectively.
Mice: Target organs were the nasal cavity (nasal mucosa and turbinate bones)
and thymus. The
lesions in mice were not as severe as those seen in rats.
Related Information:
Crotonaldehyde administration in drinking water was found to induce neoplastic
lesions in
the livers of F344 rats. F.-L. Chung, T. Tanaka, and S.S. Hecht. Induction
of liver
tumors in F344 rats by crotonaldehyde. Cancer Res. 48 (1986) 1285-1289.
18. Methyleugenol
90-Day Subchronic Gavage Study
Rats: Chemical related atrophic and chronic inflammatory lesions were found in
the glandular
stomach. Hepatocellular cytologic alterations (increase in mixed cell foci)
and both
cytomegaly and pigment accumulation within Kupffer cells were also seen. An
adenoma
occurred in the liver of one high dose male. Also observed were hypertrophy
of the
adrenal cortex, cytoplasmic alteration of the submandibular salivary gland,
minimal to
mild atrophy of the uterus, and tubular dilation and degeneration of the
testes.
Mice: Degenerative lesions were seen in the glandular stomach; these were
accompanied by
necrosis and mitotic alteration of mucosal epithelium and cystic mucosal
glands. Liver
lesions included hepatocellular necrosis and cytological alteration, biliary
hyperplasia,
and multifocal subacute inflammation.
Related Information:
In NTP sponsored chronic feed studies, there was no indication that eugenol
(methyleugenol in which a phenolic group replaces a methoxy group) was
carcinogenic for
either rats or mice. NTP Technical Report No. 223 (1983).
Although Methyleugenol is non-mutagenic in Salmonella, it can be shown to
increase
intrachromosomal and interchromosomal recombination in yeast. R.H. Schiestl,
W.S.
Chan, R.D. Gietz, R.D. Mehta, and P.J. Hastings. Safrol, eugenol, and
methyleugenol
induce intrachromosomal recombination in yeast. Mutation Res. 224 (1989)
427-436.
Methyleugenol mimics juvenile hormone activity. Z. Osmani et al., Juvenile
hormone like
activity of methyleugenol. Pesticides 13(11) 1979, 5.
There is evidence that methyleugenol can induce hepatic tumors in male mice
treated prior
to weaning. E.C. Miller, A.B. Swanson, D.H. Phillips, T.L. Fletcher, A. Liem,
and J.A.
Miller. Structure-activity studies of the carcinogenicities in the mouse and
rat of some
naturally occurring and synthetic alkenylbenzene derivatives related to safrol
and estragole.
Cancer Res. 43 (1983) 1124-1134.
19. Molybdenum Trioxide
90-Day Subchronic Inhalation Study
At doses up to 100 mg/m3, no treatment related microscopic lesions or gross
pathology
lesions were observed in either rats or mice.
20. Nitromethane
90-Day Subchronic Inhalation Study
Rats: A dose related degeneration of the olfactory epithelium was observed as
well as
degeneration within the sciatic nerve and spinal cord. Several male and
female rats
showed increased bone marrow cellularity.
Mice: Treatment-related lesions were associated with degeneration of the
olfactory epithelium
and an increased incidence of splenic extramedullary hematopoiesis.
Related Information:
There was clear evidence for tetranitromethane (CAS NO. 509-14-8) as a
carcinogen in rats
and mice, based upon increased frequencies of lung tumors in both species.
NTP
Technical Report NO. 386 (March, 1990).
21. Oxymetholone
90-Day Subchronic Gavage Study
Rats: Chronic degenerative lesions were found in the heart. The kidney showed
regenerative
lesions and diffuse renal tubule mineralization. The adrenal cortex had
cytoplasmic
vacuolization. The mammary glands of males were dilated and producing milk,
while
those of females exposed to a high dose of chemical were milk-filled and
hyperplastic.
There was evidence of uterine hydrometra and ovarian follicle atrophy.
Mice: Female animals possessed hyperplastic clitoral glands and showed atrophy
of interstitial
ovarian cells; at high doses, atrophy of the corpus luteum. Males had
decreased
epididymal sperm motility.
Related Information:
Oxymetholone is an anabolic steroid with activities similar to those of
testosterone.
There is evidence that oxymetholone is a promoter for rat liver
carcinogenesis. N. Shimoji,
K. Imaida, R. Hasigawa, C. Matsuoka, C.T. Uneyama, M. Takahashi, and Y.
Hayashi.
Enhancing effect of oxymetholone, an anabolic steroid, on development of liver
cell foci in
rats initiated with N-diethylnitrosamine. Cancer Lett. 49 (1990) 165-168.
22. Phenolphthalein
90-Day Subchronic Dosed-Feed Study
Rats: There were no histopathologic lesions associated with exposure to the
chemical.
Mice: Both males and females showed significantly elevated levels of
micronucleated
erythrocytes in animals exposed to 0.6% and higher doses of chemical. Despite
normal
weight gain, there was cell depletion, necrosis, and increased bone marrow
pigmentation.
Changes in sperm morphology, sperm density, and depressed epididymal weight
were
also observed.
Related Information:
In limited studies, phenolphthalein was administered orally to rats (160
mg/kg) and mice
(5-200 mg/kg) for up to five months. No tumors developed and there was no
evidence of
toxicity. L. Schmidt, Arch. Exper. Path. Pharmacol. 226 (1955) 207-218.
W.J. Visek, W.C. Liu, and L.J. Roth. J. Pharmacol. Exp. Ther. 117 (1956)
347-357.
23. Primaclone
90-Day Subchronic Dosed-Feed Study
Rats: There was a dose-related increase in liver lesions (hepatocellular
centrilobular
hypertrophy) in males and females; renal nephropathy (renal tubule epithelial
regeneration
or chronic nephropathy) was found in males.
Mice: Treatment related lesions in the liver (hepatocellular centrilobular
hypertrophy), spleen
(hematopoietic cell proliferation) and adrenal gland (cytoplasmic alterations
in the adrenal
cortex) were observed in both males and females.
Related Information:
Phenobarbital, a potential metabolite of primaclone, induced the formation of
liver tumors
in both rats and mice. IARC, 1977, International Agency for Research on
Cancer. Some
Miscellaneous Pharmaceutical Substances, Vol. 13, In: IARC Monographs on the
Evaluation of Carcinogenic Risk of Chemicals to Man. Lyon, France IARC, pp.
157-181.
Phenobarbital also functions as a promoter of liver tumors.
24. Pyridine
90-Day Subchronic Inhalation Study
Rats: Females showed liver lesions, while males showed liver and kidney
lesions. The kidney
lesions were similar to those described for alpha-2-microglobulin nephropathy
and
included a slight exacerbation of spontaneously occurring aging changes. The
liver
changes consisted of hepatocyte degeneration, hepatocyte hypertrophy, chronic
inflammation, and pigment accumulation in macrophages of the centrilobular
area.
Mice: No lesions were seen in males or females at doses up to 0.10% chemical.
Related Information:
No evidence of carcinogenicity was reported for male or female F344 rats
receiving
subcutaneous injections of 3, 10, 30, or 100 mg of pyridine per kg, 2 times
per week, for
12 months. M. Mason and J. Baker. Toxicology and carcinogenesis of various
chemicals
used in the preparation of vaccines. Clin. Toxicol. 4 (1971) 185-204.
25. Scopolamine Hydrobromide Trihydrate
90-Day Subchronic Gavage Study
Rats: No histopathologic changes found in any tissue examined of either males
or females. At
doses of 400, and 1200 mg/kg, salivary secretions were inhibited.
Mice: At a dose of 1200 mg/kg, female mice showed a decreased incidence of
fatty
degeneration of the adrenal cortex. No other dose-related histopathological
changes were
observed.
26. Sodium Nitrite
90-Day Subchronic Dosed Water Study
Rats: Both sexes showed minimal to mild squamous epithelial hyperplasia near
the limiting
ridge in the forestomach.
Mice: There was minimal squamous epithelial hyperplasia in the forestomach
involving the
limiting ridge, in both sexes. Increased extramedullary hematopoiesis was
observed in
both sexes. Minimal to mild testicular degeneration was also seen.
27. Xylenesulfonic Acid, Sodium Salt
90-Day Subchronic Skin Painting Study
Painting of male rats at a maximum dose of 455 mg/kg and male mice at a
maximum dose
of 1333 mg/kg resulted in minimal epidermal hyperplasia at the site of
application.
28. t-Butylhydroquinone
90-Day Subchronic Dose-Feed Study
Rats: Exposure to the chemical was associated with hyperplasia of the nasal
respiratory
epithelium in both sexes. Marginally increased splenic pigmentation was
observed in
both sexes. Females showed atrophy of the red pulp and decreased renal
mineralization.
Mice: With both sexes, chemical exposure was associated with epithelial
hyperplasia of the skin
and forestomach, as well as with inflammation of the nasal cavity.
Related Information:
B.D. Astill, C.J. Terhaar, W.J. Krasavage, G.L. Wolf, and R.L. Roudabush.
Safety
evaluation and biochemical behavior of monotertiary-butylhydroquinone. J. Am.
Oil.
Chem. Soc. 52(1975) 53-58.
29. Tetrahydrofuran
90-Day Subchronic Inhalation Study
Rats: Exposure to 5000 ppm resulted in minimal to slight acanthosis and (or)
suppurative
inflammation of the forestomach.
Mice: Exposure to 5000 ppm resulted in minimal to slight centrilobular
cytomegaly of the liver.
In addition, female mice exposed to 5000 ppm showed degeneration of the x-zone
of the
adrenal gland as well as uterine atrophy.
Related Information:
R.S. Chhabra, M.R. Elwell, B. Chou, R.A. Miller, and R.A. Renne. Subchronic
toxicity
of tetrahydrofuran vapors in rats and mice. Fundam. Appl. Toxicol. 14(1990)
338-345.
30. Vanadium Pentoxide
90-Day Subchronic Inhalation Study
Rats: Both males and females displayed proliferative pneumonitis (epithelial
hyperplasia,
inflammation, bronchiolar exudate, fibrosis, of the lung). Lesions in the
respiratory
epithelium of the nose consisted of inflammation, hyperplasia, and metaplasia.
The recommended high dose for a 2-year study is 2.0 mg/m3.
Mice: Both sexes showed epithelial hyperplasia and inflammation of the lung.
The
recommended high dose for the 2-year study is between 4.0 and 8.0 mg/m3.
It is anticipated that the 2-year chronic study will begin in 1994.
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--Boundary (ID j19WSOBMJM0a0KVa1F0h0A)--
