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CAS No.:4759-48-2

Name: Isotretinoin

Details Introduction

TOXICITY DATA with REFERENCE:

Organism Test Type Route Reported Dose (Normalized Dose) Effect Source
child TDLo oral 30mg/kg/21W (30mg/kg) MUSCULOSKELETAL: OTHER CHANGES

SKIN AND APPENDAGES (SKIN): "DERMATITIS, IRRITATIVE: AFTER SYSTEMIC EXPOSURE"

SKIN AND APPENDAGES (SKIN): NAILS: OTHER
American Journal of Diseases of Children. Vol. 142, Pg. 316, 1988.
child TDLo oral 360mg/kg/26W- (360mg/kg) SKIN AND APPENDAGES (SKIN): SWEATING: OTHER CUTIS; Cutaneous Medicine for the Practitioner. Vol. 38, Pg. 275, 1986.
man TDLo oral 24mg/kg/4W-I (24mg/kg) GASTROINTESTINAL: "HYPERMOTILITY, DIARRHEA"

GASTROINTESTINAL: OTHER CHANGES
Gastroenterology. Vol. 93, Pg. 606, 1987.
man TDLo oral 37mg/kg/5W-I (37mg/kg) SKIN AND APPENDAGES (SKIN): "DERMATITIS, IRRITATIVE: AFTER SYSTEMIC EXPOSURE"

IMMUNOLOGICAL INCLUDING ALLERGIC: DECREASED IMMUNE RESPONSE
Archives of Dermatology. Vol. 122, Pg. 815, 1986.
man TDLo unreported 21mg/kg/3W-I (21mg/kg) SKIN AND APPENDAGES (SKIN): "DERMATITIS, OTHER: AFTER SYSTEMIC EXPOSURE" British Medical Journal. Vol. 290, Pg. 820, 1985.
mouse LD50 intraperitoneal 138mg/kg (138mg/kg)   "The Retinoids, Vol.2," Sporn, M.B., et al., eds., New York, Academic Press, Inc., 1984Vol. 2, Pg. 287, 1984.
mouse LD50 oral 3389mg/kg (3389mg/kg)   "The Retinoids, Vol.2," Sporn, M.B., et al., eds., New York, Academic Press, Inc., 1984Vol. 2, Pg. 287, 1984.
rabbit LD50 oral 1960mg/kg (1960mg/kg)   "The Retinoids, Vol.2," Sporn, M.B., et al., eds., New York, Academic Press, Inc., 1984Vol. 2, Pg. 287, 1984.
rat LD50 intraperitoneal 901mg/kg (901mg/kg)   Journal of the American Academy of Dermatology. Vol. 6, Pg. 652, 1982.
rat LD50 oral > 4gm/kg (4000mg/kg)   Journal of the American Academy of Dermatology. Vol. 6, Pg. 652, 1982.
women TDLo oral 56mg/kg/8W-I (56mg/kg) SKIN AND APPENDAGES (SKIN): "DERMATITIS, IRRITATIVE: AFTER SYSTEMIC EXPOSURE" CUTIS; Cutaneous Medicine for the Practitioner. Vol. 37, Pg. 115, 1986.


Consensus Reports:

Reported in EPA TSCA Inventory.


SAFETY PROFILE:

Hazard Codes: ToxicT
Risk Codes: 61-36/37/38-20/21/22
R61:May cause harm to the unborn child. 
R20/21/22: Harmful by inhalation, in contact with skin and if swallowed. 
R36/37/38: Irritating to eyes, respiratory system and skin.
Safety Codes: 53-26-36/37/39-45
S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical
advice. 
S36/37/39: Wear suitable protective clothing, gloves and eye/face protection.
S45: In case of accident or if you feel unwell, seek medical advice immediately (show the
label whenever possible.)
S53: Avoid exposure - obtain special instructions before use.
WGK Germany: 3
RTECS: VH6440000
Poison by intraperitoneal route. Moderately toxic by ingestion. A human teratogen by ingestion with fetal developmental abnormalities of the skin and appendages and other postnatal effects. Human reproductive effects. Human systemic effects: decreased immune response, diarrhea, hypermotility, irritative dermatitis, sweating. Human mutation data reported. An experimental teratogen. Other experimental reproductive effects. When heated to decomposition it emits acrid smoke and irritating fumes.


Standards and Recommendations:

 


Analytical Methods:

 


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