Registration Dossier
Registration Dossier
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EC number: 200-888-1 | CAS number: 75-64-9
Endpoint summary
Administrative data
Description of key information
NOAEC: 0.2 mg/L air (females only), however there was no NOAEL for males.
Key value for chemical safety assessment
Additional information
In a 4 week study four groups of 15 male and 15 female Sprague-Dawley rats per group were exposed to tertiary butylamine (TBA)vapor at 0, 0.2, 0.5 and 1.98 mg/L for six hours each workday for four weeks. Gross signs of toxicity were limited to the high exposure group and included an decrease in mean body weight, generally poor health, nasal irritation, respiratory difficulties and death in one male. In the high dose group other treatment-related effects observed were increased organ to body weight ratios for the brain in both sexes and for the adrenal and testes in males. According the report the „no-effect" (NOEC) level for both male and female rats was 0.5 mg/L t-butylamine vapor (Monsanto 1981; reliability score: 2).
In a 13 week study four groups of 15 male and 15 female Sprague-Dawley rats were exposed to TBA-vapor at 0, 0.2, 0.5 and 2.01 mg/L for 6h/d, each workday for a ca.13 week period. Clinical signs were similar to the 4 week study. Four male and 7 female rats in the high exposure group died or were sacrificed. High exposure male and female rats exhibited mild lymphopenia, neutrophilia, an elevation in liver associated enzymes and decreased blood glucose. Microscopic examinations revealed severe chronic inflammation of the trachea and a secondary increase in neutrophilic leucocytes of the bone marrow in the high exposure grou . The study showed an elevation in liver associated enzymes; ALP, SGOT and SGPT were increased in the high dose group. This suggests mild liver toxicity. There was no NOAEC for males; however, the NOAEC and LOAEC for females was 0.2 mg/L, the lowest dose tested, and 0.5 mg/L, respectively. (Monsanto 1985; reliability score: 2).
Justification for classification or non-classification
There is no need for classification based on repeated dose studies.
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