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: T
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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