The Registry of Toxic Effects of Chemical Substances

Caffeine

RTECS #: EV6475000

CAS #: 58-08-2

UPDATE: May 2005 MW: 194.22 MF: C8H10N4O2


NOTE:

TABLE OF CONTENTS:
  1. SYNONYMS:
  2. MUTATION DATA:
  3. REPRODUCTIVE EFFECTS DATA:
  4. TUMORIGENIC DATA:
  5. ACUTE TOXICITY DATA:
  6. OTHER MULTIPLE DOSE DATA:
  7. REVIEWS:
  8. STANDARDS AND REGULATIONS:
  9. NIOSH DOCUMENTATION AND SURVEILLANCE:
  10. STATUS IN FEDERAL AGENCIES:
  11. REFERENCES:

SYNONYMS:

  1. Anhydrous caffeine
  2. Caffeina (Italian)
  3. Caffein
  4. Coffein (German)
  5. Coffeine
  6. Coffeinum
  7. 3,7 - Dihydro - 1,3,7 - trimethyl - 1H - purine - 2,6 - dione
  8. Eldiatric C
  9. Guaranine
  10. Kofein (Czech)
  11. Koffein (German)
  12. Methyltheobromide
  1. NCI - C02733
  2. NO - Doz
  3. Organex
  4. 1H - Purine - 2,6 - dione, 3,7 - dihydro - 1,3,7 - trimethyl -
  5. Thein
  6. Theine
  7. Theobromine, 1 - methyl -
  8. Theophylline, 7 - methyl
  9. 1,3,7 - Trimethyl - 2,6 - dioxopurine
  10. 1,3,7 - Trimethylxanthine
  11. Xanthine, 1,3,7 - trimethyl


SKIN AND EYE IRRITATION DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
N/R
 N/R N/R N/R


MUTATION DATA AND REFERENCES:

SYSTEM TEST ROUTE/
ORGANISM/
TISSUE 		DOSE REFERENCE
cytogenetic analysis chicken fibroblast 25 mmol/L NATWAY 59,277,1972
cytogenetic analysis hamster ovary 2 mmol/L CGCGBR 41,202,1986
cytogenetic analysis hamster lung 10 mmol/L HEREAY 69,35,1971
cytogenetic analysis hamster other cell types 25 mmol/L/2 hour- continuous MUREAV 12,463,1971
cytogenetic analysis hamster fibroblast 1 gm/L ESKHA5 (96),55,1978
cytogenetic analysis human leukocyte 100 mg/L MUREAV 3,249,1966
cytogenetic analysis human fibroblast 2,600 µmol/L/24 hour MUREAV 46,297,1977
cytogenetic analysis human lymphocyte 100 µg/L/24 hour MUREAV 48,205,1977
cytogenetic analysis human embryo 50 ppm/24 hour IDZAAW 46,337,1971
cytogenetic analysis human HeLa cell 500 mg/L RBPMB2 10,60,1977
cytogenetic analysis oral
mouse 		14 mg/kg/7 day- continuous DCTODJ 17,113,1994
cytogenetic analysis intravenous
mouse 		50 mg/kg MUREAV 60,329,1979
cytogenetic analysis mouse Ascites tumor 7,700 µmol/L PHARAT 32,178,1977
cytogenetic analysis mouse lymphocyte 100 mg/L ENMUDM 5,383,1983
cytogenetic analysis intraperitoneal
mouse 		50 mg/kg ETOPFR 15,79,2004
cytogenetic analysis other microorganisms 5,000 ppm IJEBA6 13,387,1975
dominant lethal test oral
mouse 		2,520 mg/kg/1 week- continuous DMWOAX 92,2315,1967
DNA damage Escherichia coli 1,000 ppm/3 minute MGGEAE 118,373,1972
DNA damage mammal (species unspecified) lymphocyte 100 mmol/L PNASA6 48,686,1962
DNA damage intraperitoneal
mouse 		100 mg/kg ATSUDG 5,355,1982
DNA damage mouse leukocyte 100 µmol/L CRNGDP 12,1781,1991
DNA inhibition Escherichia coli 10 mmol/L CBINA8 40,141,1982
DNA inhibition hamster lung 1 mmol/L CNREA8 33,2444,1973
DNA inhibition human HeLa cell 1 mmol/L RAREAE 37,334,1969
DNA inhibition human other cell types 4 mmol/L BIOJAU 35,665,1981
DNA inhibition mammal (species unspecified) lymphocyte 10 mmol/L CRNGDP 3,151,1982
DNA inhibition intraperitoneal
mouse 		50 mg/kg IJEBA6 20,433,1982
DNA inhibition oral
mouse 		208 mg/kg/7 day- continuous IJEBA6 22,608,1984
DNA inhibition mouse lymphocyte 5 mmol/L MUREAV 26,73,1974
DNA inhibition mouse fibroblast 5 mmol/L MUREAV 26,73,1974
DNA inhibition other microorganisms 2,500 mg/L MGGEAE 150,301,1977
DNA inhibition other microorganisms 30 mmol/L CRNGDP 3,151,1982
DNA inhibition other microorganisms 10 mmol/L CRNGDP 3,151,1982
DNA inhibition rat other cell types 200 µmol/L REXMAS 192,115,1992
DNA repair Bacillus subtilis 1 gm/L MUREAV 16,165,1972
DNA repair Escherichia coli 10 pph AGACBH 4,286,1974
DNA repair human fibroblast 750 µmol/L ASMACK 75,107,1975
DNA repair Salmonella typhimurium 10 pph AGACBH 4,286,1974
unscheduled DNA synthesis human other cell types 1 mmol/L BIOJAU 35,665,1981
host-mediated assay mouse
Ascites tumor 		150 mg/kg MUREAV 243,109,1990
mutation in microorganisms Bacillus subtilis 2,500 mg/L (-enzymatic activation step) MUREAV 117,55,1983
mutation in microorganisms Escherichia coli 6,000 ppm/48 hour (-enzymatic activation step) AMNTA4 85,119,1951
mutation in microorganisms Klebsiella pneumoniae 2 gm/L (-enzymatic activation step) EXPEAM 25,85,1969
mutation in microorganisms other microorganisms 2,000 ppm (-enzymatic activation step) HEREAY 36,134,1950
mutation in microorganisms other microorganisms 400 mg/L (-enzymatic activation step) MUREAV 43,37,1977
micronucleus test oral
hamster 		300 mg/kg MUREAV 174,53,1986
micronucleus test mouse embryo 7 mmol/L TCMUD8 5,123,1985
micronucleus test oral
mouse 		100 mg/kg MUREAV 174,53,1986
micronucleus test multiple
non-mammalian species 		100 ppm/8 day- continuous MUREAV 125,275,1984
micronucleus test rat kidney 10 mmol/L MUREAV 189,299,1987
gene conversion and mitotic recombination Saccharomyes cerevisiae 10 pph AGACBH 4,286,1974
gene conversion and mitotic recombination Schizosaccharomyces pombe 1,000 ppm MUREAV 26,83,1974
mutation in mammalian somatic cells mouse lymphocyte 500 mg/L ENMUDM 5,383,1983
morphological transform hamster embryo 125 mg/L CBINA8 13,105,1976
morphological transform rat embryo 320 µg/plate JJATDK 1,190,1981
other mutation test systems Escherichia coli 1,500 mg/L MILEDM 26,7,1984
other mutation test systems human lymphocyte 1 mmol/L MUREAV 15,197,1972
other mutation test systems intraperitoneal
mouse 		50 mg/kg IJEBA6 20,433,1982
other mutation test systems other microorganisms 1 pph IJEBA6 13,387,1975
sister chromatid exchange hamster lung 4 mmol/L MUREAV 174,21,1986
sister chromatid exchange oral
hamster 		300 mg/kg MUREAV 174,53,1986
sister chromatid exchange human lymphocyte 1 mmol/L HEREAY 91,135,1979
sister chromatid exchange intravenous
mouse 		50 mg/kg MUREAV 60,329,1979
sister chromatid exchange oral
mouse 		5 gm/kg/5 day- continuous MUREAV 122,347,1983
sister chromatid exchange mouse other cell types 100 µmol/L TJADAB 32,213,1985
sex chromosome loss and nondisjunction oral
Drosophila melanogaster 		5,000 ppm GENEA3 44,146,1973
sex chromosome loss and nondisjunction parenteral
Drosophila melanogaster 		5,000 ppm AMNTA4 93,135,1959
sex chromosome loss and nondisjunction Neurospora crassa 750 mg/L MUREAV 167,35,1986
sex chromosome loss and nondisjunction Saccharomyes cerevisiae 250 mg/L EVHPAZ 31,97,1979
specific locus test oral
Drosophila melanogaster 		3,000 ppm FCTOD7 24,835,1986
specific locus test intraperitoneal
mouse 		35 mg/kg ENMUDM 1,120,1979


REPRODUCTIVE EFFECTS DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
intraperitoneal
mouse 		lowest published toxic dose: 250 mg/kg (10 day pregnant) Reproductive: Effects on embryo or fetus: Fetal death KAIZAN 36,521,1961
intraperitoneal
mouse 		lowest published toxic dose: 500 mg/kg (11-12 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Other developmental abnormalities 		TJADAB 28,427,1983
intraperitoneal
mouse 		lowest published toxic dose: 200 mg/kg (12 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) 		JJPAAZ 19,134,1969
intraperitoneal
mouse 		lowest published toxic dose: 200 mg/kg (12 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system

Reproductive: Other developmental abnormalities 		JJPAAZ 19,134,1969
intraperitoneal
rat 		lowest published toxic dose: 420 mg/kg (1-21 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on fertility: Litter size (e.g., # fetuses per litter; measured before birth)

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) 		JRPFA4 34,495,1973
intraperitoneal
rat 		lowest published toxic dose: 75 mg/kg (12 day pregnant) Reproductive: Specific developmental abnormalities: Central nervous system

Reproductive: Specific developmental abnormalities: Eye, ear 		TJADAB 25,95,1982
intravenous
mouse 		lowest published toxic dose: 200 mg/kg (13 day pregnant) Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue)

Reproductive: Other developmental abnormalities 		JJPAAZ 26,751,1976
intravenous
rat 		lowest published toxic dose: 37,500 µg/kg (11 day pregnant) Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) TJADAB 25(2),54A,1982
intravenous
rat 		lowest published toxic dose: 25 mg/kg (6 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system ANANAU 168,109,1989
intravenous
rat 		lowest published toxic dose: 113 mg/kg (11 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system TOXID9 3,65,1983
multiple
mouse 		lowest published toxic dose: 408 mg/kg (9 week prior to copulation/12 day pregnant) Reproductive: Specific developmental abnormalities: Skin and skin appendages SEIJBO 6,171,1966
oral
hamster 		lowest published toxic dose: 8,160 mg/kg (60 day male) Reproductive: Effects on newborn: Sex ratio JRPFA4 43,141,1975
oral
mouse 		lowest published toxic dose: 1 gm/kg (8-12 day pregnant) Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain) JTEHD6 10,541,1982
oral
mouse 		lowest published toxic dose: 350 mg/kg (8 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system TCMUD8 5,3,1985
oral
mouse 		lowest published toxic dose: 1,650 mg/kg (6-16 day pregnant) Reproductive: Specific developmental abnormalities: Central nervous system

Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue)

Reproductive: Specific developmental abnormalities: Musculoskeletal system 		TXCYAC 23,57,1982
oral
mouse 		lowest published toxic dose: 1,650 mg/kg (6-16 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) 		TXCYAC 23,57,1982
oral
mouse 		lowest published toxic dose: 2,691 mg/kg (5-18 day pregnant) Reproductive: Other developmental abnormalities TXCYAC 23,57,1982
oral
mouse 		lowest published toxic dose: 3.26 gm/kg (7 day male/7 day prior to copulation/21 day pregnant) Reproductive: Effects on newborn: Sex ratio NTIS** #PB85101202/AS
oral
mouse 		lowest published toxic dose: 4 gm/kg (1 week male/12 week prior to copulation) Reproductive: Effects on newborn: Live birth index (Litter size (e.g., # fetuses per litter; measured after birth) NTIS** #PB85101202/AS
oral
mouse 		lowest published toxic dose: 88 mg/kg (multigenerations) Reproductive: Specific developmental abnormalities: Hepatobiliary system

Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain) 		NTIS** #PB85101202/AS
oral
mouse 		lowest published toxic dose: 770 mg/kg (7 day male/7 day prior to copulation/21 day pregnant) Reproductive: Effects on newborn: Live birth index (Litter size (e.g., # fetuses per litter; measured after birth) NTIS** #PB85101202/AS
oral
rat 		lowest published toxic dose: 627 mg/kg (1-22 day pregnant) Reproductive: Effects on newborn: Biochemical and metabolic

Reproductive: Effects on newborn: Other postnatal measures or effects 		EXPEAM 36,1105,1980
oral
rat 		lowest published toxic dose: 85 mg/kg (3-19 day pregnant) Reproductive: Effects on newborn: Behavioral

Reproductive: Effects on newborn: Physical 		NTOTDY 8,29,1986
oral
rat 		lowest published toxic dose: 200 mg/kg (13-14 day pregnant) Reproductive: Effects on embryo or fetus: Extra embryonic structures (e.g., placenta, umbilical cord)

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus) 		TJADAB 26(3),8A,1982
oral
rat 		lowest published toxic dose: 1,750 mg/kg (15-21 day pregnant) Reproductive: Specific developmental abnormalities: Blood and lymphatic systems (including spleen and marrow)

Reproductive: Specific developmental abnormalities: Homeostasis 		TXAPA9 22,449,1972
oral
rat 		lowest published toxic dose: 660 mg/kg (1-22 day pregnant) Reproductive: Effects on fertility: Female fertility index (e.g., # females pregnant per # sperm positive females; # females pregnant per # females mated)

Reproductive: Specific developmental abnormalities: Urogenital system

Reproductive: Effects on newborn: Weaning or lactation index (e.g., # alive at weaning per # alive at day 4) 		TXAPA9 44,1,1978
oral
rat 		lowest published toxic dose: 114 mg/kg (1-19 day pregnant) Reproductive: Specific developmental abnormalities: Musculoskeletal system FCHNA9 22(26),35,1980
oral
rat 		lowest published toxic dose: 120 mg/kg (12 day pregnant) Reproductive: Effects on embryo or fetus: Maternal- fetal exchange FAATDF 4,240,1984
oral
rat 		lowest published toxic dose: 150 mg/kg (2-11 day pregnant) Reproductive: Other developmental abnormalities RFDEEH 11,211,1999
oral
rat 		lowest published toxic dose: 2,975 mg/kg (multigeneration) Reproductive: Effects on fertility: Litter size (e.g., # fetuses per litter; measured before birth)

Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain) 		TOXID9 30,121,1996
oral
rat 		lowest published toxic dose: 11,900 mg/kg (multigeneration) Reproductive: Effects on embryo or fetus: Fetal death TOXID9 30,121,1996
oral
rat 		lowest published toxic dose: 12.5 mg/kg (multigenerations) Reproductive: Effects on newborn: Growth statistics (e.g., reduced weight gain) NTIS** #PB96-211743
oral
rat 		lowest published toxic dose: 25 mg/kg (multigenerations) Reproductive: Specific developmental abnormalities: Urogenital system NTIS** #PB96-211743
oral
rat 		lowest published toxic dose: 437.5 mg/kg (7 day male/7 day prior to copulation/21 day pregnant) Reproductive: Effects on newborn: Other neonatal measures or effects NTIS** #PB96-211743
oral
rat 		lowest published toxic dose: 50 mg/kg (multigenerations) Reproductive: Effects on newborn: Live birth index (Litter size (e.g., # fetuses per litter; measured after birth) NTIS** #PB96-211743
oral
woman 		lowest published toxic dose: 6,750 mg/kg (1-39 week pregnant) Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue)

Reproductive: Specific developmental abnormalities: Musculoskeletal system 		LANCAO 1,1415,1981
oral
woman 		lowest published toxic dose: 3,276 mg/kg (1-39 week pregnant) Reproductive: Maternal effects: Parturition

Reproductive: Effects on newborn: Stillbirth 		POMDAS 62,64,1977
oral
woman 		lowest published toxic dose: 1,092 mg/kg (1-91 day pregnant) Reproductive: Effects on fertility: Abortion POMDAS 62,64,1977
oral
woman 		lowest published toxic dose: 84 mg/kg (1-42 day pregnant) Reproductive: Effects on fertility: Abortion NEJMAG 343,1839,2000
subcutaneous
mouse 		lowest published toxic dose: 200 mg/kg (12 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on embryo or fetus: Fetotoxicity (except death, e.g., stunted fetus)

Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue) 		JJPAAZ 19,134,1969
subcutaneous
mouse 		lowest published toxic dose: 150 mg/kg (13 day pregnant) Reproductive: Specific developmental abnormalities: Craniofacial (including nose and tongue)

Reproductive: Specific developmental abnormalities: Musculoskeletal system

Reproductive: Other developmental abnormalities 		TJADAB 12,79,1975
subcutaneous
mouse 		lowest published toxic dose: 150 mg/kg (13 day pregnant) Reproductive: Effects on fertility: Post- implantation mortality (e.g., dead and/or resorbed implants per total number of implants)

Reproductive: Effects on fertility: Litter size (e.g., # fetuses per litter; measured before birth) 		TJADAB 12,79,1975
subcutaneous
mouse 		lowest published toxic dose: 400 mg/kg (13 day pregnant) Reproductive: Specific developmental abnormalities: Gastrointestinal system FOMOAJ 29,316,1970
subcutaneous
rat 		lowest published toxic dose: 200 mg/kg (4 day male) Reproductive: Effects on newborn: Viability index (e.g., # alive at day 4 per # born alive) PCBRD2 36,49,1980


TUMORIGENIC DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
oral
mouse 		lowest published toxic dose: 30,800 mg/kg/44 week- continuous Tumorigenic: Carcinogenic by RTECS criteria

Skin and Appendages: Tumors

Tumorigenic: Increased incidence of tumors in susceptible strains 		CNREA8 48,2078,1988
oral
rat 		lowest published toxic dose: 4,200 mg/kg/10 week- continuous Tumorigenic: Neoplastic by RTECS criteria

Gastrointestinal: Colon tumors

Tumorigenic: Facilitates action of known carcinogens 		CALEDQ 143,229,1999


ACUTE TOXICITY DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
intramuscular
infant 		lowest published toxic dose: 36 mg/kg Behavioral: Tremor

Behavioral: Ataxia 		AJDCAI 134,495,1980
intramuscular
rabbit 		lowest published lethal dose: 200 mg/kg N/R JPETAB 1,572,1910
intraperitoneal
cat 		lowest published lethal dose: 180 mg/kg N/R HBAMAK 4,1335,1935
intraperitoneal
guinea pig 		lowest published lethal dose: 220 mg/kg N/R HBAMAK 4,1335,1935
intraperitoneal
mouse 		lethal dose (50 percent kill): 168 mg/kg Behavioral: Change in motor activity (specific assay)

Behavioral: Aggression

Kidney, Ureter, and Bladder: Urine volume increased 		CPBTAL 22,1459,1974
intraperitoneal
rat 		lethal dose (50 percent kill): 240 mg/kg N/R ZERNAL 15,64,1976
intraperitoneal
rat 		lowest published toxic dose: 0.3 mg/kg Behavioral: Change in psychophysiological tests BJMRDK 35,1201,2002
intraperitoneal
rabbit 		lowest published lethal dose: 150 mg/kg N/R HBAMAK 4,1335,1935
intravenous
cat 		lowest published lethal dose: 80 mg/kg N/R HBAMAK 4,1335,1935
intravenous
cat 		lowest published toxic dose: 20 mg/kg Vascular: Measurement of regional blood flow FATOAO 50,39,1987
intravenous
cattle 		lowest published toxic dose: 2.5 mg/kg Gastrointestinal: Nausea or vomiting JAPTO* 21,229,2001
intravenous
dog 		lowest published lethal dose: 4 mg/kg N/R HBAMAK 4,1335,1935
intravenous
human 		lowest published toxic dose: 7 mg/kg Behavioral: Convulsions or effect on seizure threshold APTOA6 15,331,1959
intravenous
infant 		lowest published toxic dose: 68 mg/kg Behavioral: Somnolence (general depressed activity)

Behavioral: Tremor

Behavioral: Ataxia 		AJDCAI 134,495,1980
intravenous
mouse 		lethal dose (50 percent kill): 62 mg/kg Behavioral: Convulsions or effect on seizure threshold

Lung, Thorax, or Respiration: Dyspnea 		TOLED5 29,25,1985
intravenous
rat 		lethal dose (50 percent kill): 105 mg/kg Lung, Thorax, or Respiration: Acute pulmonary edema

Kidney, Ureter, and Bladder: Structural or functional change in ureter 		JPETAB 82,89,1944
intravenous
rat 		lowest published toxic dose: 5 mg/kg Behavioral: Alteration of operant conditioning NEROEW 26,422,2002
intravenous
rat 		lowest published toxic dose: 0.5 mg/kg Biochemical: Neurotransmitters or modulators (putative): Dopamine at other sites NEROEW 27,182,2002
intravenous
rabbit 		lethal dose (50 percent kill): 58 mg/kg N/R KSRNAM 13,791,1979
intravenous
woman 		lowest published lethal dose: 57 mg/kg Behavioral: Convulsions or effect on seizure threshold

Vascular: BP elevation not characterized in autonomic section 		APTOA6 15,331,1959
oral
wild bird 		lethal dose (50 percent kill): 316 mg/kg N/R AECTCV 12,355,1983
oral
cat 		lowest published lethal dose: 100 mg/kg N/R HBAMAK 4,1335,1935
oral
child 		lowest published toxic dose: 140 mg/kg Behavioral: Muscle contraction or spasticity

Cardiac: Pulse rate increased without fall in BP

Blood: Hemorrhage 		PECAE5 10,349,1994
oral
child 		lowest published lethal dose: 320 mg/kg Behavioral: Convulsions or effect on seizure threshold

Lung, Thorax, or Respiration: Cyanosis 		FNSCA6 3,275,1974
oral
dog 		lethal dose (50 percent kill): 140 mg/kg N/R NIIRDN 6,174,1982
oral
guinea pig 		lethal dose (50 percent kill): 230 mg/kg Behavioral: Convulsions or effect on seizure threshold

Lung, Thorax, or Respiration: Respiratory depression 		TXAPA9 2,23,1960
oral
hamster 		lethal dose (50 percent kill): 230 mg/kg Gastrointestinal: Hypermotility, diarrhea TXAPA9 44,1,1978
oral
human 		lowest published lethal dose: 192 mg/kg N/R JNDRAK 5,252,1965
oral
human 		lowest published toxic dose: 2 mg/kg Behavioral: Toxic psychosis

Vascular: BP elevation not characterized in autonomic section 		PSCHDL 157,373,2001
oral
human 		lowest published toxic dose: 8.57 mg/kg Behavioral: Change in psychophysiological tests

Cardiac: Change in rate

Gastrointestinal: Nausea or vomiting 		PSCHDL 159,238,2002
oral
human 		lowest published toxic dose: 2.14 mg/kg Behavioral: Change in psychophysiological tests NEROEW 28,371,2003
oral
infant 		lowest published toxic dose: 14,700 µg/kg Behavioral: Muscle contraction or spasticity CLBIAS 10,148,1977
oral
man 		lowest published toxic dose: 51 mg/kg Cardiac: Change in rate

Kidney, Ureter, and Bladder: Changes in tubules (including acute renal failure, acute tubular necrosis)

Musculoskeletal: Tumors 		AEMED3 18,94,1989
oral
man 		lowest published toxic dose: 13 mg/kg Behavioral: Toxic psychosis AJPSAO 143,1320,1986
oral
mouse 		lethal dose (50 percent kill): 127 mg/kg Gastrointestinal: Hypermotility, diarrhea TXAPA9 44,1,1978
oral
rat 		lethal dose (50 percent kill): 192 mg/kg Brain and Coverings: Other degenerative changes

Behavioral: Withdrawal

Kidney, Ureter, and Bladder: Interstitial nephritis 		JNDRAK 5,252,1965
oral
rabbit 		lethal dose (50 percent kill): 224 mg/kg Gastrointestinal: Hypermotility, diarrhea TXAPA9 44,1,1978
oral
woman 		lowest published lethal dose: 400 mg/kg Behavioral: Convulsions or effect on seizure threshold

Cardiac: Other changes

Skin and Appendages: Other: Sweating 		VHTODE 39,228,1997
oral
woman 		lowest published toxic dose: 96 mg/kg/1 day- intermittent Behavioral: Hallucinations, distorted perceptions

Behavioral: Toxic psychosis

Gastrointestinal: Hypermotility, diarrhea 		JOPDAB 105,493,1984
oral
woman 		lowest published lethal dose: 1 gm/kg Gastrointestinal: Nausea or vomiting BIATDR -,6,1973
parenteral
frog 		lowest published lethal dose: 120 mg/kg Behavioral: Convulsions or effect on seizure threshold

Behavioral: Stiffness

Cardiac: Other changes 		AEPPAE 166,437,1932
rectal
rat 		lethal dose (50 percent kill): 300 mg/kg N/R JCPHB8 7,131,1967
subcutaneous
cat 		lowest published lethal dose: 150 mg/kg N/R HBAMAK 4,1335,1935
subcutaneous
dog 		lethal dose (50 percent kill): 100 mg/kg N/R NIIRDN 6,174,1982
subcutaneous
frog 		lowest published lethal dose: 120 mg/kg N/R APTOA6 15,331,1959
subcutaneous
guinea pig 		lowest published lethal dose: 200 mg/kg N/R HBAMAK 4,1335,1935
subcutaneous
mouse 		lethal dose (50 percent kill): 242 mg/kg N/R ARZNAD 6,601,1956
subcutaneous
pigeon 		lowest published lethal dose: 140 mg/kg N/R JPETAB 1,572,1910
subcutaneous
rat 		lethal dose (50 percent kill): 170 mg/kg N/R JCPHB8 7,131,1967
subcutaneous
rabbit 		lowest published lethal dose: 275 mg/kg N/R JPETAB 1,572,1910
unreported route
mouse 		lethal dose (50 percent kill): 251 mg/kg N/R NYKZAU 53,2S,1957


OTHER MULTIPLE DOSE DATA AND REFERENCES:

ROUTE/
ORGANISM 		DOSE
EFFECT

 REFERENCE
intramuscular
mouse 		lowest published toxic dose: 13,671 mg/kg/21 week- continuous Nutritional and Gross Metabolic: Weight loss or decreased weight gain NTIS** #PB85101202/AS
intramuscular
mouse 		lowest published toxic dose: 13,671 mg/kg/21 week- continuous Liver: Changes in liver weight

Reproductive: Paternal effects: Testes, epididymis, sperm duct

Reproductive: Paternal effects: Prostate, seminal vesicle, Cowper's gland, accessory glands 		NTIS** #PB85101202/AS
intramuscular
mouse 		lowest published toxic dose: 1,540 mg/kg/5 week- continuous Skin and Appendages: Other: Hair NTIS** #PB85101202/AS
intramuscular
rat 		lowest published toxic dose: 87.5 mg/kg/7 day- intermittent Nutritional and Gross Metabolic: Weight loss or decreased weight gain NTIS** #PB96-211743
intramuscular
rat 		lowest published toxic dose: 175 mg/kg/7 day- intermittent Behavioral: Food intake (animal) NTIS** #PB96-211743
intramuscular
rat 		lowest published toxic dose: 87.5 mg/kg/7 day- intermittent Reproductive: Paternal effects: Spermatogenesis (including genetic material, sperm morphology, motility, and count) NTIS** #PB96-211743
intramuscular
rat 		lowest published toxic dose: 1,750 mg/kg/20 week- intermittent Kidney, Ureter, and Bladder: Changes in kidney weight NTIS** #PB96-211743
intramuscular
rat 		lowest published toxic dose: 1,750 mg/kg/20 week- intermittent Liver: Changes in liver weight NTIS** #PB96-211743
intraperitoneal
rat 		lowest published toxic dose: 1,050 mg/kg/21 day- intermittent Behavioral: Withdrawal JOPSEQ 11,219,1997
oral
mouse 		lowest published toxic dose: 9.66 mg/kg/15 week- continuous Behavioral: Food intake (animal)

Behavioral: Change in motor activity (specific assay)

Biochemical: Metabolism (intermediary): Lipids including transport 		LIFSAK 73,1383,2003
oral
rat 		lowest published toxic dose: 33,210 mg/kg/90 day- continuous Gastrointestinal: Changes in structure or function of salivary glands TOXID9 5,97,1985
oral
rat 		lowest published toxic dose: 380 mg/kg/4 week- intermittent Endocrine: Changes in pituitary weight

Blood: Changes in other cell count (unspecified) 		IJEBA6 22,298,1984
oral
rat 		lowest published toxic dose: 39,900 mg/kg/19 week- continuous Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Related to Chronic Data: Changes in testicular weight 		JEPTDQ 2(3),687,1979
oral
rat 		lowest published toxic dose: 16,800 mg/kg/8 week- continuous Behavioral: Food intake (animal)

Endocrine: Changes in thymus weight

Related to Chronic Data: Changes in testicular weight 		FCTOD7 22,365,1984
oral
rat 		lowest published toxic dose: 157 gm/kg/75 week- continuous Endocrine: Changes in adrenal weight

Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Related to Chronic Data: Changes in testicular weight 		JEPTDQ 2(3),687,1979
oral
rat 		lowest published toxic dose: 303.24 mg/kg/12 week- continuous Nutritional and Gross Metabolic: Weight loss or decreased weight gain

Tumorigenic: Active as anti-cancer agent 		FCTOD7 39,541,2001
oral
rat 		lowest published toxic dose: 7,280 mg/kg/52 week- continuous Tumorigenic: Protects against induction of experimental tumors EMMUEG 39,271,2002
skin
mouse 		lowest published toxic dose: 2,880 mg/kg/12 week- intermittent Tumorigenic: Protects against induction of experimental tumors PNASA6 99,13455,2002


REVIEWS:

ORGANIZATION STANDARD
REFERENCE
International Agency for Research on Cancer (IARC) Cancer Review Human Inadequate Evidence IMEMDT 51,291,1991
International Agency for Research on Cancer (IARC) Cancer Review Animal Inadequate Evidence IMEMDT 51,291,1991
International Agency for Research on Cancer (IARC) Cancer Review Group 3 IMEMDT 51,291,1991
TOXICOLOGY REVIEW
FCTOD7 40,1271,2002
TOXICOLOGY REVIEW
FCTOD7 40,1235,2002
TOXICOLOGY REVIEW
FCTOD7 40,1243,2002
TOXICOLOGY REVIEW
CLPTAT 5,480,1964
TOXICOLOGY REVIEW
32XPAD -,49,1975
TOXICOLOGY REVIEW
ADVPA3 4,263,1966
TOXICOLOGY REVIEW
FNSCA6 2,67,1973
TOXICOLOGY REVIEW
FAATDF 13,747,1989
TOXICOLOGY REVIEW
EPIRD7 14,83,1992
TOXICOLOGY REVIEW
FCTOD7 40,9,2001
TOXICOLOGY REVIEW
TOLED5 144,383,2003


STANDARDS AND REGULATIONS:

ORGANIZATION STANDARD
REFERENCE
Occupational Exposure Limit - RUSSIA short term exposure limit 0.5 mg/m3, JAN1993


NIOSH DOCUMENTATION AND SURVEILLANCE:

ORGANIZATION STANDARD or SURVEY
REFERENCE
National Occupational Hazard Survey 1974 National Occupational Hazard Survey 1974: Hazard Code: M1132;
Number of Industries 6;
Total Number of Facilities 893;
Number of Occupations 7;
Total Number of Employees Exposed 5,715
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: M1132;
Number of Industries 19;
Total Number of Facilities 1,707;
Number of Occupations 23;
Total Number of Employees Exposed 19,593;
Total Number of Female Employees Exposed 11,199
National Occupational Exposure Survey 1983 National Occupational Exposure Survey 1983: Hazard Code: X9210;
Number of Industries 2;
Total Number of Facilities 38;
Number of Occupations 5;
Total Number of Employees Exposed 373;
Total Number of Female Employees Exposed 92


STATUS IN FEDERAL AGENCIES:

ORGANIZATION
REFERENCE
EPA GENETOX PROGRAM 1988, Positive: Cell transform.-SA7/SHE; In vitro cytogenetics-nonhuman
EPA GENETOX PROGRAM 1988, Positive: D melanogaster-whole sex chrom. loss
EPA GENETOX PROGRAM 1988, Positive: D melanogaster-nondisjunction; N crassa-aneuploidy
EPA GENETOX PROGRAM 1988, Positive: E coli polA without S9; In vitro SCE-human
EPA GENETOX PROGRAM 1988, Positive: D melanogaster Sex-linked lethal; S cerevisiae-aneuploidy
EPA GENETOX PROGRAM 1988, Positive/dose response: In vitro cytogenetics-human lymphocyte
EPA GENETOX PROGRAM 1988, Negative: SHE-clonal assay; Rodent dominant lethal
EPA GENETOX PROGRAM 1988, Negative: Histidine reversion-Ames test; In vitro SCE-nonhuman
EPA GENETOX PROGRAM 1988, Negative: Mouse specific locus; Sperm morphology-mouse
EPA GENETOX PROGRAM 1988, Negative: UDS in mouse germ cells; V79 cell culture-gene mutation
EPA GENETOX PROGRAM 1988, Negative: TRP reversion
EPA GENETOX PROGRAM 1988, Negative/limited: Carcinogenicity-mouse/rat
EPA GENETOX PROGRAM 1988, Inconclusive: In vivo cytogenetics-nonhuman bone marrow
EPA GENETOX PROGRAM 1988, Inconclusive: Cytogenetics-male germ cell
EPA GENETOX PROGRAM 1988, Inconclusive: Rodent heritable translocation; Mammalian micronucleus
EPA GENETOX PROGRAM 1988, Inconclusive: Mouse spot test; B subtilis rec assay
EPA GENETOX PROGRAM 1988, Inconclusive: In vitro SCE-human lymphocytes; In vivo SCE-nonhuman
EPA TSCA Section 8(b) CHEMICAL INVENTORY
Used as a pharmaceutical and veterinary drug
EPA TSCA Section 8(d) unpublished health/safety studies
EPA TSCA TEST SUBMISSION (TSCATS) DATA BASE, JANUARY 2001


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CODEN
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Used as a pharmaceutical and veterinary drug

FDA-over the counter and proprietary drug

RTECS Compound Description:
   Tumorigen
   Drug
   Mutagen
   Reproductive Effector
   Human Data
   Natural Product

 Click Here for Additional Information about RTECS