Federal Register: June 12, 2002 (Volume 67, Number 113)
DOCID: FR Doc 02-14821
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: National Toxicology Program:
SUBJECT CATEGORY:
National Toxicology Program (NTP)
DOCUMENT SUMMARY:
Announcement of and Request for Public Comments on Substances Nominated to the National Toxicology Program (NTP) for Toxicological Studies and on Study Recommendations Made by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC)
Summary
The NTP continuously solicits and accepts nominations for toxicological
[[Page 40330]]
studies to be undertaken by the program. Nominations of substances of
potential human health concern are received from Federal agencies, the
public, and other interested parties. These nominations undergo several
levels of review before selections for testing are made and
toxicological studies are designed and implemented. Evaluation by the
NTP ICCEC is the initial external review step in the NTP's formal
selection process for NTP study nominations. On April 17, 2002 the
ICCEC met to review 19 new nominations and make study recommendations.
This announcement (1) provides brief background information regarding
the substances nominated to NTP for study, (2) presents the ICCEC's
study recommendations from its April 17, 2002 meeting, (3) solicits
public comment on the nominations themselves and on the study
recommendations by the ICCEC, and (4) requests the submission of
additional relevant information for consideration by the NTP in its continued evaluation of these nominations.
Review of Study Nominations
At it's meeting on April 17, 2002, the ICCEC reviewed 19 new nominations for NTP studies. For 14 of these nominations, one or more types of toxicological studies were recommended, and for 5 nominations, no studies were recommended at this time. The nominated substances with CAS numbers, nomination source, nomination rationale, specific study recommendations, and other pertinent information are given in the attached tables.
Evaluation by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC) is the initial external review step in the NTP's formal selection process for NTP study nominations. The ICCEC is composed of representatives from the Agency for Toxic Substances and Disease Registry, U.S. Consumer Product Safety Commission, Department of Defense, U.S. Environmental Protection Agency, U.S. Food and Drug Administration's National Center for Toxicological Research, National Cancer Institute, National Center for Environmental Health, National Institute of Environmental Health Sciences, National Institute for Occupational Safety and Health, National Library of Medicine, and the Occupational Safety and Health Administration. The ICCEC meets once or twice annually to evaluate groups of new study nominations and to make recommendations with respect to both specific types of studies and testing priorities.
Request for Public Comments
Interested parties are invited to submit comments or supplementary information on the nominated substances and study recommendations that appear in the attached tables. The NTP welcomes toxicology and carcinogenesis information from completed, ongoing, or planned studies, as well as information on current production levels, use patterns, human exposure, environmental occurrence, or public health concerns for any of the nominated substances. The NTP is also interested in identifying appropriate new animal models for mechanistic based research, including transgenic or knockout mice, and welcomes comments regarding the use of specific animal models to address scientific questions relevant to the nominated substances and studies under consideration. All information received will be considered by the NTP in its continued review of these nominations. Comments or information should be sent to Dr. Scott Masten by August 12, 2002. Persons responding to this request should include their name, affiliation, mailing address, phone, fax, email address and sponsoring organization (if any) with the submission. Written submissions will be made available electronically on the NTP's web site as they are received.
An electronic copy of this announcement, internet links to electronic versions of supporting documents for each nomination, and further information on the NTP and the NTP Chemical Nomination and Selection Process can be accessed through the NTP web site: http://ntp server.niehs.nih.gov.
Send comments or information to Dr. Scott A. Masten, Office of Chemical Nomination and Selection, NIEHS/NTP, P. O. Box 12233, MD A3 07, Research Triangle Park, North Carolina 27709; telephone: (919) 541 5710; FAX: (919) 5413647; email: masten@niehs.nih.gov. Background
The NTP actively seeks to identify and select for study chemicals and other agents for which sufficient information is not available to adequately evaluate potential human health hazards. The NTP accomplishes this goal through a formal open nomination and selection process. Substances considered appropriate for study generally fall into two broad yet overlapping categories: (1) Those substances of greatest concern for public health based on the extent of human exposure and/or suspicion of toxicity; and (2) substances for which toxicological data gaps exist and additional studies would aid in assessing potential human health risks, e.g. by facilitating cross species extrapolation or evaluating doseresponse relationships. Input is also solicited regarding 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 classes of chemical, biological, or physical substances. Substances may be studied to evaluate a variety of healthrelated effects, including but not limited to reproductive and developmental toxicity, genotoxicity, immunotoxicity, neurotoxicity, metabolism and disposition, and carcinogenicity. In reviewing and selecting nominated substances, the NTP also considers legislative mandates that require responsible private sector commercial organizations to evaluate their products for health and environmental effects. The possible human health consequences of anticipated or known human exposure, however, remain the overriding factor in the NTP's decision to study a particular substance.
The review and selection of substances nominated for study is a
multistep process. A broad range of concerns are addressed during this
process through the participation of representatives from the National
Institute of Environmental Health Sciences, other Federal agencies, the
NTP Board of Scientific Counselorsan external scientific advisory
body, the NTP Executive Committeethe NTP Federal interagency policy
body, and the public. This process is described in further detail in a
March 2, 2000 Federal Register announcement (Volume 65, Number 42,
pages 1132911331). This multistep evaluative process provides the NTP
with 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). As such, it should be recognized that at
any given time, the new study nominations under consideration do not
necessarily reflect the overall balance of substances historically or
currently being evaluated by the NTP in it's testing program. For
further information on NTP toxicology studies (previous or in progress) visit
[[Page 40331]]
the NTP web site at http://ntpserver.niehs.nih.gov.
Dated: June 5, 2002.
Samuel Wilson,
Deputy Director, National Toxicology Program.
Attachment
Substances Nominated to the NTP for Toxicological Studies and Recommendations Made by the ICCEC on April 17, 2002
Table 1.Substances Recommended for Study
Nomination rationale; Recommendations for
Substance [CAS No.] Nominated by other information toxicological studies
Abrasive blasting agents; Coal slag; National Institute for High production volume Chronic inhalation
Crushed glass; Garnet; Sand; Occupational Safety and widespread toxicity in male rats;
Specular hematite; Steel grit. and Health; occupational exposure; Pulmonary tissue
Occupational Safety lack of adequate burden analysis.
and Health health effects
Administration. information; data
needed to establish
safe exposure limits.
5Aminoocresol [2835952]......... National Cancer Widely used in Metabolism;
Institute. permanent hair dyes; Developmental and
some evidence of reproductive toxicity;
toxicity; lack of Carcinogenicity.
carcinogenicity data.
tertButyl hydroperoxide [75912]... National Cancer High production volume Carcinogenicity;
Institute. industrial chemical; Consider mechanistic
evidence for studies related to
genotoxicity and tumor carcinogenicity of
promotion activity; organic peroxides as a
lack of class.
carcinogenicity data.
ChloramineT [127651] and p Private Individual..... Investigational new In vitro and in vivo
Toluenesulfonamide [70553]. animal drug for genotoxicity;
antimicrobial use in Subchronic toxicity;
aquaculture; evidence and/or carcinogenicity
for toxicity further studies may be
studies needed to considered when
establish safe residue results of
levels. genotoxicity studies
are available for
review.
Cobalt metal dust [7440484]........ Cobalt Development Widespread occupational Toxicological
Institute; exposure; evidence for characterization
International Union, toxicity; insufficient including
United Auto Workers; data to assess chronic carcinogenicity and
Occupational Safety toxicity and developmental toxicity
and Health carcinogenic potential. (inhalation studies). Administration.
Ephedrine alkaloid dietary National Cancer Widely used dietary Developmental and
supplements [no CAS No.]. Institute; National supplement; reports of reproductive toxicity;
Institutes of Health adverse effects in Subchronic toxicity;
Office of Dietary consumers; lack of Special emphasis on
Supplements. adequate toxicological assessment of
information for multi potential
component dietary cardiovascular and
supplement central ervous systems
formulations. effects;
Studies should use
commercial ephedra
products with and
without caffeine and
other additives.
Ethanone, 1(1,2,3,4,5,6,7,8 Private Individual..... High production volume Toxicological
octahydro2,3,8,8tetramethyl2 fragrance material; characterization
naphthalenyl)(IsoE Super) [54464 widespread consumer including
572]. exposure; lack of genotoxicity.
toxicity data.
Hexafluorosilicic acid [16961834] Private Individuals Primary agents used to Chemical
and Sodium hexafluorosilicate [16893 (multiple nominations). fluoridate public characterization
859]. drinking water studies to assess
systems; lack of chemical fate under
toxicity information; aqueous conditions;
assumed complete Toxicological studies
dissociation to free may be considered when
fluoride under normal results of chemical
conditions of use not characterization
supported by studies are available
experimental evidence. for review.
Ketamine hydrochloride [1867669]... U.S. Food and Drug Approved drug for Comprehensive
Administration. anesthetic use in neurotoxicity
adults; offlabel assessment and
pediatric use thought toxicokinetics in
to occur; causes developing (post
severe lesions in natal) nonhuman
developing rat brain; primates.
further studies needed
to assess safety of
pediatric use. [[Page 40332]]
Mercury, ((ocarboxyphenyl)thio)ethyl U.S. Food and Drug Organomercurial Toxicokinetics;
,sodium salt (Thimerosal) [54648]. Administration. preservative widely Neurodevelopmental
used in vaccines and toxicity;
other therapeutics; Comparative studies
large exposed with ethylmercury and
population; methylmercury under
insufficient toxicity different dosing
data. regimens in nonhuman
primates;
Coordinate with
ongoing federally
sponsored research
efforts.
Nitrogen trifluoride [7783542]..... National Cancer Rapidly increasing Genotoxicity;
Institute. industrial demand; Metabolism.
acute toxic effects
well described;
potential for toxicity
based on oxidizing
properties.
Sodium metasilicate [6834920]...... National Institute for Widespread occupational Subchronic toxicity
Occupational Safety exposure; evidence for (inhalation studies);
and Health. biological activity; Respiratory
insufficient toxicity hypersensitivity.
data.
Turpentine [8006642]............... International Union, Widespread occupational Chronic toxicity;
United Auto Workers. and consumer exposure; Carcinogenicity.
reports of kidney
toxicity in exposed
humans; insufficient
chronic toxicity
information.
Welding fume: Gas metal arc welding National Institute for Widespread Occupational Acute and subchronic
with stainless steel electrode; Gas Occupational Safety exposure; evidence for inhalation exposure
metal arc welding with mild steel and Health; toxicity of mixture studies to assess
electrode; Manual arc welding with International Union; and components; gaps neurotoxicity,
stainless steel electrode. United Auto Workers. in available health immunotoxicity, and
effects data. pulmonary toxicity of
all 3 welding fume
types;
Chronic inhalation
toxicity and
carcinogenicity
studies with one or
more welding fume
types.
Table 2.Substances for Which No Study Is Recommended at This Time
Rationale for
Nomination recommending no
Substance [CAS No.] Nominated by Nominated for rationale; other toxicological
information studies
Hexachloro1,3butadiene [8768 Carcinogen Carcinogenicity Persistent Low commercial
3]. Identification (at doses industrial by production
Committee intermediate to product widely volume,
(Advisory Body those used in dispersed in insufficient
for California previous studies). environment; some evidence of
Environmental evidence for significant human
Protection carcinogenicity; exposure, and
Agency). existing data availability of
insufficient to adequate
characterize toxicological
carcinogenic data.
hazard.
Infrasound [no CAS No.]......... National Institute Toxicological Low frequency Insufficient
of Environmental characterization. sound ubiquitous information on
Health Sciences. in occupational human exposures
and community in community
settings; settings and
insufficient questionable
settings; utility of
insufficient data additional
to address public studies in
concerns available animal
regarding models/test
potential health systems; Consider
hazards at low seeking
exposure levels. additional expert
opinion on human
exposure and
toxicity data
needs.
Magnesium oxide [1309484]..... National Cancer Biological High production Adequate available
Institute. disposition. volume industrial toxicological
Chronic chemical; data.
inhalation widespread
toxicity. occupational
exposure; lack of
chronic
inhalation
toxicity data.
Methylolurea [1000824]........ National Institute Toxicological High production Inclusion in the
of Environmental characterization. volume industrial High Production
Health Sciences. chemical; Volume Chemical
widespread use Challenge
and potential for Program.
human exposure;
lack of toxicity
information. [[Page 40333]]
4Methylquinoline [491350].... Carcinogen Comparative Ubiquitous Low commercial
Identification metabolism environmental production
Committee studies (with contaminant; some volume,
(Advisory Body quinoline). evidence for insufficient
for California Carcinogenicity. carcinogenicity; evidence of
Environmental existing data significant human
Protection insufficient to exposure, and
Agency). characterize availability of
carcinogenic adequate
hazard. toxicological
data.
[FR Doc. 0214821 Filed 61102; 8:45 am]
BILLING CODE 414001P
SUMMARY:
Chemicals nominated for toxicological studies; testing recommendations; comment request,
DOCUMENT BODY 2:
Announcement of and Request for Public Comments on Substances Nominated to the National Toxicology Program (NTP) for Toxicological Studies and on Study Recommendations Made by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC)
Summary
The NTP continuously solicits and accepts nominations for toxicological
[[Page 40330]]
studies to be undertaken by the program. Nominations of substances of
potential human health concern are received from Federal agencies, the
public, and other interested parties. These nominations undergo several
levels of review before selections for testing are made and
toxicological studies are designed and implemented. Evaluation by the
NTP ICCEC is the initial external review step in the NTP's formal
selection process for NTP study nominations. On April 17, 2002 the
ICCEC met to review 19 new nominations and make study recommendations.
This announcement (1) provides brief background information regarding
the substances nominated to NTP for study, (2) presents the ICCEC's
study recommendations from its April 17, 2002 meeting, (3) solicits
public comment on the nominations themselves and on the study
recommendations by the ICCEC, and (4) requests the submission of
additional relevant information for consideration by the NTP in its continued evaluation of these nominations.
Review of Study Nominations
At it's meeting on April 17, 2002, the ICCEC reviewed 19 new nominations for NTP studies. For 14 of these nominations, one or more types of toxicological studies were recommended, and for 5 nominations, no studies were recommended at this time. The nominated substances with CAS numbers, nomination source, nomination rationale, specific study recommendations, and other pertinent information are given in the attached tables.
Evaluation by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC) is the initial external review step in the NTP's formal selection process for NTP study nominations. The ICCEC is composed of representatives from the Agency for Toxic Substances and Disease Registry, U.S. Consumer Product Safety Commission, Department of Defense, U.S. Environmental Protection Agency, U.S. Food and Drug Administration's National Center for Toxicological Research, National Cancer Institute, National Center for Environmental Health, National Institute of Environmental Health Sciences, National Institute for Occupational Safety and Health, National Library of Medicine, and the Occupational Safety and Health Administration. The ICCEC meets once or twice annually to evaluate groups of new study nominations and to make recommendations with respect to both specific types of studies and testing priorities.
Request for Public Comments
Interested parties are invited to submit comments or supplementary information on the nominated substances and study recommendations that appear in the attached tables. The NTP welcomes toxicology and carcinogenesis information from completed, ongoing, or planned studies, as well as information on current production levels, use patterns, human exposure, environmental occurrence, or public health concerns for any of the nominated substances. The NTP is also interested in identifying appropriate new animal models for mechanistic based research, including transgenic or knockout mice, and welcomes comments regarding the use of specific animal models to address scientific questions relevant to the nominated substances and studies under consideration. All information received will be considered by the NTP in its continued review of these nominations. Comments or information should be sent to Dr. Scott Masten by August 12, 2002. Persons responding to this request should include their name, affiliation, mailing address, phone, fax, email address and sponsoring organization (if any) with the submission. Written submissions will be made available electronically on the NTP's web site as they are received.
An electronic copy of this announcement, internet links to electronic versions of supporting documents for each nomination, and further information on the NTP and the NTP Chemical Nomination and Selection Process can be accessed through the NTP web site: http://ntp server.niehs.nih.gov.
Send comments or information to Dr. Scott A. Masten, Office of Chemical Nomination and Selection, NIEHS/NTP, P. O. Box 12233, MD A3 07, Research Triangle Park, North Carolina 27709; telephone: (919) 541 5710; FAX: (919) 5413647; email: masten@niehs.nih.gov. Background
The NTP actively seeks to identify and select for study chemicals and other agents for which sufficient information is not available to adequately evaluate potential human health hazards. The NTP accomplishes this goal through a formal open nomination and selection process. Substances considered appropriate for study generally fall into two broad yet overlapping categories: (1) Those substances of greatest concern for public health based on the extent of human exposure and/or suspicion of toxicity; and (2) substances for which toxicological data gaps exist and additional studies would aid in assessing potential human health risks, e.g. by facilitating cross species extrapolation or evaluating doseresponse relationships. Input is also solicited regarding 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 classes of chemical, biological, or physical substances. Substances may be studied to evaluate a variety of healthrelated effects, including but not limited to reproductive and developmental toxicity, genotoxicity, immunotoxicity, neurotoxicity, metabolism and disposition, and carcinogenicity. In reviewing and selecting nominated substances, the NTP also considers legislative mandates that require responsible private sector commercial organizations to evaluate their products for health and environmental effects. The possible human health consequences of anticipated or known human exposure, however, remain the overriding factor in the NTP's decision to study a particular substance.
The review and selection of substances nominated for study is a
multistep process. A broad range of concerns are addressed during this
process through the participation of representatives from the National
Institute of Environmental Health Sciences, other Federal agencies, the
NTP Board of Scientific Counselorsan external scientific advisory
body, the NTP Executive Committeethe NTP Federal interagency policy
body, and the public. This process is described in further detail in a
March 2, 2000 Federal Register announcement (Volume 65, Number 42,
pages 1132911331). This multistep evaluative process provides the NTP
with 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). As such, it should be recognized that at
any given time, the new study nominations under consideration do not
necessarily reflect the overall balance of substances historically or
currently being evaluated by the NTP in it's testing program. For
further information on NTP toxicology studies (previous or in progress) visit
[[Page 40331]]
the NTP web site at http://ntpserver.niehs.nih.gov.
Dated: June 5, 2002.
Samuel Wilson,
Deputy Director, National Toxicology Program.
Attachment
Substances Nominated to the NTP for Toxicological Studies and Recommendations Made by the ICCEC on April 17, 2002
Table 1.Substances Recommended for Study
Nomination rationale; Recommendations for
Substance [CAS No.] Nominated by other information toxicological studies
Abrasive blasting agents; Coal slag; National Institute for High production volume Chronic inhalation
Crushed glass; Garnet; Sand; Occupational Safety and widespread toxicity in male rats;
Specular hematite; Steel grit. and Health; occupational exposure; Pulmonary tissue
Occupational Safety lack of adequate burden analysis.
and Health health effects
Administration. information; data
needed to establish
safe exposure limits.
5Aminoocresol [2835952]......... National Cancer Widely used in Metabolism;
Institute. permanent hair dyes; Developmental and
some evidence of reproductive toxicity;
toxicity; lack of Carcinogenicity.
carcinogenicity data.
tertButyl hydroperoxide [75912]... National Cancer High production volume Carcinogenicity;
Institute. industrial chemical; Consider mechanistic
evidence for studies related to
genotoxicity and tumor carcinogenicity of
promotion activity; organic peroxides as a
lack of class.
carcinogenicity data.
ChloramineT [127651] and p Private Individual..... Investigational new In vitro and in vivo
Toluenesulfonamide [70553]. animal drug for genotoxicity;
antimicrobial use in Subchronic toxicity;
aquaculture; evidence and/or carcinogenicity
for toxicity further studies may be
studies needed to considered when
establish safe residue results of
levels. genotoxicity studies
are available for
review.
Cobalt metal dust [7440484]........ Cobalt Development Widespread occupational Toxicological
Institute; exposure; evidence for characterization
International Union, toxicity; insufficient including
United Auto Workers; data to assess chronic carcinogenicity and
Occupational Safety toxicity and developmental toxicity
and Health carcinogenic potential. (inhalation studies). Administration.
Ephedrine alkaloid dietary National Cancer Widely used dietary Developmental and
supplements [no CAS No.]. Institute; National supplement; reports of reproductive toxicity;
Institutes of Health adverse effects in Subchronic toxicity;
Office of Dietary consumers; lack of Special emphasis on
Supplements. adequate toxicological assessment of
information for multi potential
component dietary cardiovascular and
supplement central ervous systems
formulations. effects;
Studies should use
commercial ephedra
products with and
without caffeine and
other additives.
Ethanone, 1(1,2,3,4,5,6,7,8 Private Individual..... High production volume Toxicological
octahydro2,3,8,8tetramethyl2 fragrance material; characterization
naphthalenyl)(IsoE Super) [54464 widespread consumer including
572]. exposure; lack of genotoxicity.
toxicity data.
Hexafluorosilicic acid [16961834] Private Individuals Primary agents used to Chemical
and Sodium hexafluorosilicate [16893 (multiple nominations). fluoridate public characterization
859]. drinking water studies to assess
systems; lack of chemical fate under
toxicity information; aqueous conditions;
assumed complete Toxicological studies
dissociation to free may be considered when
fluoride under normal results of chemical
conditions of use not characterization
supported by studies are available
experimental evidence. for review.
Ketamine hydrochloride [1867669]... U.S. Food and Drug Approved drug for Comprehensive
Administration. anesthetic use in neurotoxicity
adults; offlabel assessment and
pediatric use thought toxicokinetics in
to occur; causes developing (post
severe lesions in natal) nonhuman
developing rat brain; primates.
further studies needed
to assess safety of
pediatric use. [[Page 40332]]
Mercury, ((ocarboxyphenyl)thio)ethyl U.S. Food and Drug Organomercurial Toxicokinetics;
,sodium salt (Thimerosal) [54648]. Administration. preservative widely Neurodevelopmental
used in vaccines and toxicity;
other therapeutics; Comparative studies
large exposed with ethylmercury and
population; methylmercury under
insufficient toxicity different dosing
data. regimens in nonhuman
primates;
Coordinate with
ongoing federally
sponsored research
efforts.
Nitrogen trifluoride [7783542]..... National Cancer Rapidly increasing Genotoxicity;
Institute. industrial demand; Metabolism.
acute toxic effects
well described;
potential for toxicity
based on oxidizing
properties.
Sodium metasilicate [6834920]...... National Institute for Widespread occupational Subchronic toxicity
Occupational Safety exposure; evidence for (inhalation studies);
and Health. biological activity; Respiratory
insufficient toxicity hypersensitivity.
data.
Turpentine [8006642]............... International Union, Widespread occupational Chronic toxicity;
United Auto Workers. and consumer exposure; Carcinogenicity.
reports of kidney
toxicity in exposed
humans; insufficient
chronic toxicity
information.
Welding fume: Gas metal arc welding National Institute for Widespread Occupational Acute and subchronic
with stainless steel electrode; Gas Occupational Safety exposure; evidence for inhalation exposure
metal arc welding with mild steel and Health; toxicity of mixture studies to assess
electrode; Manual arc welding with International Union; and components; gaps neurotoxicity,
stainless steel electrode. United Auto Workers. in available health immunotoxicity, and
effects data. pulmonary toxicity of
all 3 welding fume
types;
Chronic inhalation
toxicity and
carcinogenicity
studies with one or
more welding fume
types.
Table 2.Substances for Which No Study Is Recommended at This Time
Rationale for
Nomination recommending no
Substance [CAS No.] Nominated by Nominated for rationale; other toxicological
information studies
Hexachloro1,3butadiene [8768 Carcinogen Carcinogenicity Persistent Low commercial
3]. Identification (at doses industrial by production
Committee intermediate to product widely volume,
(Advisory Body those used in dispersed in insufficient
for California previous studies). environment; some evidence of
Environmental evidence for significant human
Protection carcinogenicity; exposure, and
Agency). existing data availability of
insufficient to adequate
characterize toxicological
carcinogenic data.
hazard.
Infrasound [no CAS No.]......... National Institute Toxicological Low frequency Insufficient
of Environmental characterization. sound ubiquitous information on
Health Sciences. in occupational human exposures
and community in community
settings; settings and
insufficient questionable
settings; utility of
insufficient data additional
to address public studies in
concerns available animal
regarding models/test
potential health systems; Consider
hazards at low seeking
exposure levels. additional expert
opinion on human
exposure and
toxicity data
needs.
Magnesium oxide [1309484]..... National Cancer Biological High production Adequate available
Institute. disposition. volume industrial toxicological
Chronic chemical; data.
inhalation widespread
toxicity. occupational
exposure; lack of
chronic
inhalation
toxicity data.
Methylolurea [1000824]........ National Institute Toxicological High production Inclusion in the
of Environmental characterization. volume industrial High Production
Health Sciences. chemical; Volume Chemical
widespread use Challenge
and potential for Program.
human exposure;
lack of toxicity
information. [[Page 40333]]
4Methylquinoline [491350].... Carcinogen Comparative Ubiquitous Low commercial
Identification metabolism environmental production
Committee studies (with contaminant; some volume,
(Advisory Body quinoline). evidence for insufficient
for California Carcinogenicity. carcinogenicity; evidence of
Environmental existing data significant human
Protection insufficient to exposure, and
Agency). characterize availability of
carcinogenic adequate
hazard. toxicological
data.
[FR Doc. 0214821 Filed 61102; 8:45 am]
BILLING CODE 414001P