A cosmetic ingredients review panel concluded that magnesium stearate was not a mutagen in Salmonella TA 1535, TA 1537, TA 1538 and D4 with or with metabolic activation typhimurium Saccharomyces cerevisiae by liver and lung preparations from rats, mice and monkeys. 7.15. Chronic toxicity/carcinogenicity Lithium complex grease (80% (w/w) base oil, lithium 12-hydroxy stearate (7.5%), other additives (12%). Fifty mg of test material was applied twice weekly to the shorn interscapular region of C3H mice (50/sex). Positive controls were treated with 50 mg of a 0.05% solution of BaP in toluene and negative controls received toluene or were untreated. Applications were continued for 104 weeks or until a horny lesion on the surface of the skin grew to 1 mm3. Potential tumours were examined histologically. Species/Strain Mouse/C3H of Administration Dermal non-occluded. – Exposure Information Total exposure: 104 weeks Dose regimen: 2 days per week. Vehicle None. Group Number of mice with Number of mice with Latent period (weeks) malignant tumours benign tumours Untreated controls 46 males 0 0 50 females 1 2 Toluene controls 48 males 3 3 87 50 females 5 2 72 Test substance 47 males 0 2 67 50 females 1 0 82 BaP 46 males 21 5 48 49 females 45 2 49 The test substance was not a skin carcinogen. Developmental toxicity/teratogenicity The teratogenic effect of lithium compounds has been reviewed by Leonard (1995). A number of studies et al. in various animal species have produced mixed results. Lithium carbonate given to mice over several days to produce serum levels comparable to those achieved in patients with manic depressive disorders did not result in any effects but dosages at a 6 times higher level caused malformations in the offspring. Many authors have reported that lithium given to women in the first trimester of pregnancy causes congenital defects, especially of the cardiovascular system. As a result registers of babies” have been set up. “lithium 8. ENVIRONMENT
A cosmetic ingredients review panel concluded that magnesium stearate was not a mutagen in Salmonella typhimurium TA 1535, TA 1537, TA 1538 and Saccharomyces cerevisiae D4 with or with metabolic activation by liver and lung preparations from rats, mice and monkeys. 7.15. Chronic toxicity/carcinogenicity Lithium complex grease (80% (w/w) base oil, lithium 12-hydroxy stearate (7.5%), other additives (12%). Fifty mg of test material was applied twice weekly to the shorn interscapular region of C3H mice (50/sex). Positive controls were treated with 50 mg of a 0.05% solution of BaP in toluene and negative controls received toluene or were untreated. Applications were continued for 104 weeks or until a horny lesion on the surface of the skin grew to 1 mm3. Potential tumours were examined histologically. Species/Strain Mouse/C3H of Administration Dermal – non-occluded. Exposure Information Total exposure: 104 weeks Dose regimen: 2 days per week. Vehicle None. Group Number of mice with malignant tumours Number of mice with benign tumours Latent period (weeks) Untreated controls 46 males 50 females 0 1 0 2 Toluene controls 48 males 50 females 3 5 3 2 87 72 Test substance 47 males 50 females 0 1 2 0 67 82 BaP 46 males 49 females 21 45 5 2 48 49 The test substance was not a skin carcinogen. Developmental toxicity/teratogenicity The teratogenic effect of lithium compounds has been reviewed by Leonard et al. (1995). A number of studies in various animal species have produced mixed results. Lithium carbonate given to mice over several days to produce serum levels comparable to those achieved in patients with manic depressive disorders did not result in any effects but dosages at a 6 times higher level caused malformations in the offspring. Many authors have reported that lithium given to women in the first trimester of pregnancy causes congenital defects, especially of the cardiovascular system. As a result registers of “lithium babies” have been set up. 8. ENVIRONMENT
STD1160FR.docx