Federal Register: December 4, 2000 (Volume 65, Number 233)
DOCID: FR Doc 00-30715
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: National Toxicology Program:
SUBJECT CATEGORY:
National Toxicology Program; Request for Comments on Substances Nominated to the National Toxicology Program (NTP) for Toxicological Studies and on the Testing Recommendations Made by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC)
DOCUMENT SUMMARY:
Summary
The National Toxicology Program (NTP) routinely solicits, accepts
and reviews for consideration nominations for toxicological studies to
be undertaken by the Program on substances of potential human health
concern. Nominations are solicited widely from Federal agencies, the
public, and other interested parties and those received undergo several
levels of review before toxicological studies are designed and
implemented. The NTP Interagency Committee for Chemical Evaluation and
Coordination (ICCEC) serves as the first level of review for NTP
nominations. At the October 27, 2000 ICCEC meeting, 18 new nominations
were reviewed and testing recommendations were made. As part of an
effort to inform the public and to obtain input for consideration when
selecting chemicals for evaluation, the NTP routinely seeks public
comment on (1) substances nominated to the Program for toxicological
studies and (2) the testing recommendations made by the ICCEC. This
announcement provides brief background information about the nomination of substances for NTP study; presents the ICCEC's testing
recommendations from the October 27, 2000 meeting; solicits public
comment on those nominations and recommendations; and requests the
submission of additional relevant information for consideration by the NTP in its subsequent evaluation of the nominations.
Background
The NTP actively seeks to identify and select for study chemicals and agents with the highest potential for
[[Page 75728]]
adversely impacting public health. The nomination process is open to
all interested parties and substances selected for study generally fall
into two broad overlapping categories: (1) Those substances of greatest
concern for public or occupational health based on the extent of human
exposure and suspicion of toxicity; and (2) substances for which
toxicological data gaps exist and additional studies would aid in
assessing potential human health risks by facilitating crossspecies
extrapolation and evaluation of doseresponse relationships. Particular
assistance is also sought for the nomination of studies that permit the
testing of hypotheses to enhance the predictive ability of future NTP
studies, address mechanisms of toxicity, or fill significant gaps in
the knowledge of the toxicity of chemicals or classes of chemicals.
Substances may be studied for a variety of healthrelated effects,
including but not limited to reproductive and developmental toxicity,
genotoxicity, immunotoxicity, metabolism and disposition, as well as
carcinogenicity. Selections for NTP testing also consider legislative
mandates that require responsible manufacturers to evaluate their own
chemicals or agents for health and environmental effects. The possible
human health consequences of anticipated or known human exposure,
however, remain the overriding factor in the decision to study a particular chemical or agent.
The review and selection of substances nominated for study is a multilevel process. A broad range of concerns are addressed during this process through the participation of representatives from Federal agencies, the NTP Board of Scientific Counselorsan external scientific advisory body, the NTP Executive Committeethe NTP Federal interagency policy body, and a public comment period. This process is described in further detail in a March 2, 2000 Federal Register Announcement (Volume 65, Number 42, pages 1132911331). As a result of this multistep evaluative process for NTP nominations, the Program receives appropriate direction and guidance to ensure that it's testing program addresses toxicological concerns relative to all areas of public health, and furthermore, that there is balance among the types of substances selected for study (e.g., industrial chemicals, consumer products, therapeutic agents, etc.). As such, it must be recognized that for any given committee review, the substances being considered for new testing do not necessarily reflect the overall balance of substances historically or currently being evaluated by NTP in it's testing program. For further information on NTP studies (previous or in progress) visit the NTP web page at the URL listed at the end of this announcement.
Nominated Substances and ICCEC Review
The NTP Interagency Committee for Chemical Evaluation and
Coordination (ICCEC) is composed of representatives from the Agency for
Toxic Substances and Disease Registry, Consumer Product Safety
Commission, Department of Defense, Environmental Protection Agency,
Food and Drug Administration's National Center for Toxicological
Research, National Cancer Institute, National Institute of
Environmental Health Sciences, National Institute for Occupational
Safety and Health, National Library of Medicine, and the Occupational
Safety and Health Administration. As part of the review and selection
process for nominations, the ICCEC meets once or twice annually to
review and evaluate the nominations and to make testing recommendations
with respect to both specific types of studies and testing priorities.
At its meeting on October 27, 2000, the ICCEC reviewed 18 new nominations for NTP studies. For 15 of these nominations,
pharmacokinetic, toxicity, and/or carcinogenicity studies were
recommended. A testing recommendation for three nominations was
deferred pending receipt of (1) additional information or data from the
nominator or other organizations on related studies completed,
anticipated or in progress, or (2) additional information on
production, exposure, use patterns, and regulatory needs. The nominated
substances with CAS numbers, nomination source, types of studies
recommended, study rationale and other information are given in the attached tables.
Request for Comment
Interested parties are encouraged to provide comments or supplementary information on the nominated substances and
recommendations identified in this announcement. The NTP would welcome
receiving toxicology and carcinogenesis information from completed,
ongoing, or planned studies, as well as information on current
production levels, human exposure, use patterns, environmental
occurrence, or public health concerns for any of the substances listed
in the attached tables. Comments or information should be sent to Dr.
Scott Masten at the address given below within 60 days of the
publication date of this announcement. Persons responding to this
request are asked to include their name, affiliation, mailing address,
phone, fax, email address and sponsoring organization (if any) with
the submission. An electronic copy of this announcement as well as
further information on the NTP and the NTP Chemical Nomination and
Selection Process can be accessed through the NTP web site. The URL for
the NTP homepage is http://ntpserver.niehs.nih.gov.
Contact may be made by mail to Dr. Scott Masten, NIEHS/NTP, P. O.
Box 12233, Research Triangle Park, North Carolina 27709; by telephone at (919) 5415710; by FAX at (919) 5587067; or by email to
masten@niehs.nih.gov.
Dated: November 20, 2000.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
AttachmentSubstances Nominated to the NTP for Study and Testing Recommendations Made by the ICCEC on October 27, 2000
Table 1.Substances Recommended for Testing
Study rationale; other
Substance [CAS Number] Nominated by ICCEC recommendations information
Aluminum complexes found in Environmental Longterm drinking water Drinking water contaminants
drinking water, Aluminum Protection studies to address with a high health research
fluoride, [7784181], Aluminum Agency; National pharmacokinetics, priority; known
citrate, [31142560]. Institute of neurotoxicity, bone neurotoxicity of aluminum;
Environmental development, and need for better
Health Sciences. reproduction and understanding of
developmental toxicity. pharmacokinetics and
toxicity of aluminum
species occurring in
drinking water.
Consider testing in
transgenic animal models of
neurodegenerative disease. [[Page 75729]]
Bilberry fruit extract, [84082 National Cancer In vitro and in vivo Widespread human exposure
348]. Institute. genotoxicity testing. through use as a dietary
supplement; lack of
toxicity information.
Black cohosh, [84776261]...... National Cancer Subchronic toxicity Widespread human exposure
Institute; testing in young and aged through use as a dietary
National female animals. supplement; reported
Institute of estrogenic activity;
Environmental inadequate toxicity
Health Sciences. information.
Twogeneration
reproductive and
developmental toxicity
study.
BlueGreen algae (dietary National Cancer Subchronic toxicity and Widespread human exposure
supplements and selected Institute. neurotoxicity studies of through drinking water and
toxins). commercial bluegreen algae via contamination of algal
dietary supplements. dietary supplements;
demonstrated acute toxicity
but only limited chronic
toxicity information
available.
Consider testing specific
cyanobacterial toxins
pending results of Blue
Green algae dietary
supplement and microcystin
LR studies.
Cefuroxime, [55268752]........ Food and Drug Genotoxicity testing Prescription drug with
Administration. (Syrian hamster embryo in widespread and potentially
vitro cell transformation longterm use; lack of
assay; in vivo micronucleus chronic toxicity data for
assay). any member of this class of
drugs.
Clarithromycin, [81103119].... Food and Drug Genotoxicity testing Prescription drug with
Administration. (Syrian hamster embryo in widespread and potentially
vitro cell transformation longterm use; numerous
assay; in vivo micronucleus known toxicities in short
assay). term studies; lack of
chronic toxicity data.
D&C Red No. 27, [13473262] and Food and Drug In vitro percutaneous Approved colorings for drugs
D&C Red No. 28, [18472872]. Administration. absorption testing. and cosmetics that can lead
to DNA damage; lack of
sufficient data on long
term phototoxicity or
photocarcinogenicity.
Photocarcinogenicity
testing dependent on
results of absorption
studies.
N,NDimethylptoluidine, [9997 National Cancer Subchronic toxicity High production volume
8]. Institute. testing pending review of chemical with potential for
industry test plans and/or widespread human exposure
data developed under EPA's and limited chronic
High Production Volume toxicity or carcinogenicity
Chemical Challenge Program. data; genotoxic; suspicion
of carcinogenicity.
Lemon Oil, [8008568] and Lime Food and Drug Photogenotoxicity testing. Widespread consumer exposure
Oil, [8008262]. Administration. as a fragrance component;
known phototoxicity; long
term toxicity unknown.
Photocarcinogenicity
testing dependent on
results of
phototogenotoxicity studies.
Local anesthetics that Private Shortterm in vitro/in Widespread clinical use and
metabolize to 2,6xylidine or o Individual; vivo mechanistic studies to human exposure; potentially
toluidine, Bupivacaine, [38396 National evaluate carcinogenic metabolized to carcinogenic
393], Prilocaine, [721506]. Institute of metabolite formation and and neurotoxic
Environmental genotoxicity of intermediates; little
Health Sciences. representative local available quantitative
anesthetic compounds. metabolism or genotoxicity
data.
MicrocystinLR, [101043372]... National Institute Toxicokinetic, subchronic, Cyanobacteria and their
of Environmental reproductive toxicity, toxins are drinking water
Health Sciences. chronic toxicity and contaminants with a high
carcinogenicity studies health research priority;
including doses relevant to many have high acute
environmental toxicity and known
concentrations in drinking hepatotoxicity and
water. hepatocarcinogenicity.
Consider carcinogenicity
testing in Japanese Medaka
fish model.
Organotins occurring in drinking Environmental Longterm single chemical Drinking water contaminants
water, Monomethyltin Protection and binary mixture drinking with a high health research
trichloride, [993168], Agency; National water studies to address priority; numerous
Dimethyltin dichloride, [75373 Institute of pharmacokinetics, organotins have
1], Monobutyltin trichloride, Environmental neurotoxicity, demonstrated a broad
[1118463], Dibutyltin Health Sciences. immunotoxicity, and spectrum of toxicity;
dichloride, [683181]. reproductive and chronic toxicity
developmental toxicity. information on organotin
species primarily found in
drinking water is limited.
Consider testing in
transgenic animal models of
neurodegenerative disease.
Alltransretinyl palmitate, [79 Food and Drug Phototoxicity and Widespread use in cosmetic
812]. Administration. photocarcinogenicity products; known biochemical
testing. and histological cutaneous
alterations; other
retinoids known to enhance
photocarcinogenesis. [[Page 75730]]
SAdenosylmethionine, [2990803 National Cancer In vitro genotoxicity Widespread exogenous human
0]. Institute. testing (Syrian hamster exposure through use as a
embryo cell transformation dietary supplement; limited
and DNA alkylation assays). toxicity data available.
Subchronic toxicity
testing dependent on
results of genotoxicity
studies.
Senna........................... Food and Drug..... Carcinogenicity testing in Data needed to complete
p53. safety
[8013114]..................... Administration.... transgenic mouse model...... evaluation of stimulant
laxatives; transgenic
studies will complement
manufacturer sponsored
carcinogenicity studies.
Table 2.Substances for Which a Testing Recommendation is Deferred Pending Receipt and Consideration of Additional Information Additional
Substance [CAS Number] Nominated by Nominated for Nomination rationale information needed
1,3Dichloropropane, [14228 Environmental Shortterm Drinking water Additional drinking
9], 2,2Dichloropropane, [594 Protection comprehensive contaminants with water occurrence
207], 1,1Dichloropropene, Agency; drinking water high health research data; production
[563586]. National toxicity priority; very volumes; potential
Institute of studies. limited toxicity sources of drinking
Environmental data; known toxicity water contamination;
Health Sciences. and carcinogenicity anticipated
of structurally regulatory value of
similar compounds. additional toxicity
data.
Pharmacokineti cs.
Medaka studies
Testing in
human bladder cell
transformation model.
Hydergine, [8067241]........ National Cancer Genotoxicity Ergot alkaloid Dietary supplement
Institute. testing. prescription drug sales and use
with recent increase information;
in ``off label'' and regulatory agency
dietary supplement information needs.
use in healthy
individuals; lack of
available
information on
toxicity and
carcinogenicity.
Yohimbe bark extract, [85117 National Cancer Micronucleus Significant human Dietary supplement
222], Yohimbine, [146485]. Institute. assay. exposure through use use levels and
as a dietary patterns; regulatory
supplement; agency informaiton
suspicion of needs.
carcinogenicity of
yohimbine based on
structural
similarity to
reserpine.
[FR Doc. 0030715 Filed 12100; 8:45 am]
BILLING CODE 414000M
SUMMARY:
Chemicals nominated for toxicology studies; testing recommendations; comment request,
DOCUMENT BODY 2:
Summary
The National Toxicology Program (NTP) routinely solicits, accepts
and reviews for consideration nominations for toxicological studies to
be undertaken by the Program on substances of potential human health
concern. Nominations are solicited widely from Federal agencies, the
public, and other interested parties and those received undergo several
levels of review before toxicological studies are designed and
implemented. The NTP Interagency Committee for Chemical Evaluation and
Coordination (ICCEC) serves as the first level of review for NTP
nominations. At the October 27, 2000 ICCEC meeting, 18 new nominations
were reviewed and testing recommendations were made. As part of an
effort to inform the public and to obtain input for consideration when
selecting chemicals for evaluation, the NTP routinely seeks public
comment on (1) substances nominated to the Program for toxicological
studies and (2) the testing recommendations made by the ICCEC. This
announcement provides brief background information about the nomination of substances for NTP study; presents the ICCEC's testing
recommendations from the October 27, 2000 meeting; solicits public
comment on those nominations and recommendations; and requests the
submission of additional relevant information for consideration by the NTP in its subsequent evaluation of the nominations.
Background
The NTP actively seeks to identify and select for study chemicals and agents with the highest potential for
[[Page 75728]]
adversely impacting public health. The nomination process is open to
all interested parties and substances selected for study generally fall
into two broad overlapping categories: (1) Those substances of greatest
concern for public or occupational health based on the extent of human
exposure and suspicion of toxicity; and (2) substances for which
toxicological data gaps exist and additional studies would aid in
assessing potential human health risks by facilitating crossspecies
extrapolation and evaluation of doseresponse relationships. Particular
assistance is also sought for the nomination of studies that permit the
testing of hypotheses to enhance the predictive ability of future NTP
studies, address mechanisms of toxicity, or fill significant gaps in
the knowledge of the toxicity of chemicals or classes of chemicals.
Substances may be studied for a variety of healthrelated effects,
including but not limited to reproductive and developmental toxicity,
genotoxicity, immunotoxicity, metabolism and disposition, as well as
carcinogenicity. Selections for NTP testing also consider legislative
mandates that require responsible manufacturers to evaluate their own
chemicals or agents for health and environmental effects. The possible
human health consequences of anticipated or known human exposure,
however, remain the overriding factor in the decision to study a particular chemical or agent.
The review and selection of substances nominated for study is a multilevel process. A broad range of concerns are addressed during this process through the participation of representatives from Federal agencies, the NTP Board of Scientific Counselorsan external scientific advisory body, the NTP Executive Committeethe NTP Federal interagency policy body, and a public comment period. This process is described in further detail in a March 2, 2000 Federal Register Announcement (Volume 65, Number 42, pages 1132911331). As a result of this multistep evaluative process for NTP nominations, the Program receives appropriate direction and guidance to ensure that it's testing program addresses toxicological concerns relative to all areas of public health, and furthermore, that there is balance among the types of substances selected for study (e.g., industrial chemicals, consumer products, therapeutic agents, etc.). As such, it must be recognized that for any given committee review, the substances being considered for new testing do not necessarily reflect the overall balance of substances historically or currently being evaluated by NTP in it's testing program. For further information on NTP studies (previous or in progress) visit the NTP web page at the URL listed at the end of this announcement.
Nominated Substances and ICCEC Review
The NTP Interagency Committee for Chemical Evaluation and
Coordination (ICCEC) is composed of representatives from the Agency for
Toxic Substances and Disease Registry, Consumer Product Safety
Commission, Department of Defense, Environmental Protection Agency,
Food and Drug Administration's National Center for Toxicological
Research, National Cancer Institute, National Institute of
Environmental Health Sciences, National Institute for Occupational
Safety and Health, National Library of Medicine, and the Occupational
Safety and Health Administration. As part of the review and selection
process for nominations, the ICCEC meets once or twice annually to
review and evaluate the nominations and to make testing recommendations
with respect to both specific types of studies and testing priorities.
At its meeting on October 27, 2000, the ICCEC reviewed 18 new nominations for NTP studies. For 15 of these nominations,
pharmacokinetic, toxicity, and/or carcinogenicity studies were
recommended. A testing recommendation for three nominations was
deferred pending receipt of (1) additional information or data from the
nominator or other organizations on related studies completed,
anticipated or in progress, or (2) additional information on
production, exposure, use patterns, and regulatory needs. The nominated
substances with CAS numbers, nomination source, types of studies
recommended, study rationale and other information are given in the attached tables.
Request for Comment
Interested parties are encouraged to provide comments or supplementary information on the nominated substances and
recommendations identified in this announcement. The NTP would welcome
receiving toxicology and carcinogenesis information from completed,
ongoing, or planned studies, as well as information on current
production levels, human exposure, use patterns, environmental
occurrence, or public health concerns for any of the substances listed
in the attached tables. Comments or information should be sent to Dr.
Scott Masten at the address given below within 60 days of the
publication date of this announcement. Persons responding to this
request are asked to include their name, affiliation, mailing address,
phone, fax, email address and sponsoring organization (if any) with
the submission. An electronic copy of this announcement as well as
further information on the NTP and the NTP Chemical Nomination and
Selection Process can be accessed through the NTP web site. The URL for
the NTP homepage is http://ntpserver.niehs.nih.gov.
Contact may be made by mail to Dr. Scott Masten, NIEHS/NTP, P. O.
Box 12233, Research Triangle Park, North Carolina 27709; by telephone at (919) 5415710; by FAX at (919) 5587067; or by email to
masten@niehs.nih.gov.
Dated: November 20, 2000.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
AttachmentSubstances Nominated to the NTP for Study and Testing Recommendations Made by the ICCEC on October 27, 2000
Table 1.Substances Recommended for Testing
Study rationale; other
Substance [CAS Number] Nominated by ICCEC recommendations information
Aluminum complexes found in Environmental Longterm drinking water Drinking water contaminants
drinking water, Aluminum Protection studies to address with a high health research
fluoride, [7784181], Aluminum Agency; National pharmacokinetics, priority; known
citrate, [31142560]. Institute of neurotoxicity, bone neurotoxicity of aluminum;
Environmental development, and need for better
Health Sciences. reproduction and understanding of
developmental toxicity. pharmacokinetics and
toxicity of aluminum
species occurring in
drinking water.
Consider testing in
transgenic animal models of
neurodegenerative disease. [[Page 75729]]
Bilberry fruit extract, [84082 National Cancer In vitro and in vivo Widespread human exposure
348]. Institute. genotoxicity testing. through use as a dietary
supplement; lack of
toxicity information.
Black cohosh, [84776261]...... National Cancer Subchronic toxicity Widespread human exposure
Institute; testing in young and aged through use as a dietary
National female animals. supplement; reported
Institute of estrogenic activity;
Environmental inadequate toxicity
Health Sciences. information.
Twogeneration
reproductive and
developmental toxicity
study.
BlueGreen algae (dietary National Cancer Subchronic toxicity and Widespread human exposure
supplements and selected Institute. neurotoxicity studies of through drinking water and
toxins). commercial bluegreen algae via contamination of algal
dietary supplements. dietary supplements;
demonstrated acute toxicity
but only limited chronic
toxicity information
available.
Consider testing specific
cyanobacterial toxins
pending results of Blue
Green algae dietary
supplement and microcystin
LR studies.
Cefuroxime, [55268752]........ Food and Drug Genotoxicity testing Prescription drug with
Administration. (Syrian hamster embryo in widespread and potentially
vitro cell transformation longterm use; lack of
assay; in vivo micronucleus chronic toxicity data for
assay). any member of this class of
drugs.
Clarithromycin, [81103119].... Food and Drug Genotoxicity testing Prescription drug with
Administration. (Syrian hamster embryo in widespread and potentially
vitro cell transformation longterm use; numerous
assay; in vivo micronucleus known toxicities in short
assay). term studies; lack of
chronic toxicity data.
D&C Red No. 27, [13473262] and Food and Drug In vitro percutaneous Approved colorings for drugs
D&C Red No. 28, [18472872]. Administration. absorption testing. and cosmetics that can lead
to DNA damage; lack of
sufficient data on long
term phototoxicity or
photocarcinogenicity.
Photocarcinogenicity
testing dependent on
results of absorption
studies.
N,NDimethylptoluidine, [9997 National Cancer Subchronic toxicity High production volume
8]. Institute. testing pending review of chemical with potential for
industry test plans and/or widespread human exposure
data developed under EPA's and limited chronic
High Production Volume toxicity or carcinogenicity
Chemical Challenge Program. data; genotoxic; suspicion
of carcinogenicity.
Lemon Oil, [8008568] and Lime Food and Drug Photogenotoxicity testing. Widespread consumer exposure
Oil, [8008262]. Administration. as a fragrance component;
known phototoxicity; long
term toxicity unknown.
Photocarcinogenicity
testing dependent on
results of
phototogenotoxicity studies.
Local anesthetics that Private Shortterm in vitro/in Widespread clinical use and
metabolize to 2,6xylidine or o Individual; vivo mechanistic studies to human exposure; potentially
toluidine, Bupivacaine, [38396 National evaluate carcinogenic metabolized to carcinogenic
393], Prilocaine, [721506]. Institute of metabolite formation and and neurotoxic
Environmental genotoxicity of intermediates; little
Health Sciences. representative local available quantitative
anesthetic compounds. metabolism or genotoxicity
data.
MicrocystinLR, [101043372]... National Institute Toxicokinetic, subchronic, Cyanobacteria and their
of Environmental reproductive toxicity, toxins are drinking water
Health Sciences. chronic toxicity and contaminants with a high
carcinogenicity studies health research priority;
including doses relevant to many have high acute
environmental toxicity and known
concentrations in drinking hepatotoxicity and
water. hepatocarcinogenicity.
Consider carcinogenicity
testing in Japanese Medaka
fish model.
Organotins occurring in drinking Environmental Longterm single chemical Drinking water contaminants
water, Monomethyltin Protection and binary mixture drinking with a high health research
trichloride, [993168], Agency; National water studies to address priority; numerous
Dimethyltin dichloride, [75373 Institute of pharmacokinetics, organotins have
1], Monobutyltin trichloride, Environmental neurotoxicity, demonstrated a broad
[1118463], Dibutyltin Health Sciences. immunotoxicity, and spectrum of toxicity;
dichloride, [683181]. reproductive and chronic toxicity
developmental toxicity. information on organotin
species primarily found in
drinking water is limited.
Consider testing in
transgenic animal models of
neurodegenerative disease.
Alltransretinyl palmitate, [79 Food and Drug Phototoxicity and Widespread use in cosmetic
812]. Administration. photocarcinogenicity products; known biochemical
testing. and histological cutaneous
alterations; other
retinoids known to enhance
photocarcinogenesis. [[Page 75730]]
SAdenosylmethionine, [2990803 National Cancer In vitro genotoxicity Widespread exogenous human
0]. Institute. testing (Syrian hamster exposure through use as a
embryo cell transformation dietary supplement; limited
and DNA alkylation assays). toxicity data available.
Subchronic toxicity
testing dependent on
results of genotoxicity
studies.
Senna........................... Food and Drug..... Carcinogenicity testing in Data needed to complete
p53. safety
[8013114]..................... Administration.... transgenic mouse model...... evaluation of stimulant
laxatives; transgenic
studies will complement
manufacturer sponsored
carcinogenicity studies.
Table 2.Substances for Which a Testing Recommendation is Deferred Pending Receipt and Consideration of Additional Information Additional
Substance [CAS Number] Nominated by Nominated for Nomination rationale information needed
1,3Dichloropropane, [14228 Environmental Shortterm Drinking water Additional drinking
9], 2,2Dichloropropane, [594 Protection comprehensive contaminants with water occurrence
207], 1,1Dichloropropene, Agency; drinking water high health research data; production
[563586]. National toxicity priority; very volumes; potential
Institute of studies. limited toxicity sources of drinking
Environmental data; known toxicity water contamination;
Health Sciences. and carcinogenicity anticipated
of structurally regulatory value of
similar compounds. additional toxicity
data.
Pharmacokineti cs.
Medaka studies
Testing in
human bladder cell
transformation model.
Hydergine, [8067241]........ National Cancer Genotoxicity Ergot alkaloid Dietary supplement
Institute. testing. prescription drug sales and use
with recent increase information;
in ``off label'' and regulatory agency
dietary supplement information needs.
use in healthy
individuals; lack of
available
information on
toxicity and
carcinogenicity.
Yohimbe bark extract, [85117 National Cancer Micronucleus Significant human Dietary supplement
222], Yohimbine, [146485]. Institute. assay. exposure through use use levels and
as a dietary patterns; regulatory
supplement; agency informaiton
suspicion of needs.
carcinogenicity of
yohimbine based on
structural
similarity to
reserpine.
[FR Doc. 0030715 Filed 12100; 8:45 am]
BILLING CODE 414000M