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Key value for chemical safety assessment

Effects on fertility

Additional information

For toxicity to reproduction, the most recent reliable studies were selected as the key study.

Short description of key information:
In a repeated-dose male reproductive toxicity study (NTP-CERHR, 2003 citing Wu, 1999), which was not conducted in accordance with an applicable OECD Guideline or GLP, several effects of subcutaneous injection of 2-bromopropane at increasing concentrations in mature and immature rats were observed at the lowest dose tested (200 mg/kg bw/day). Rats were dosed 5 days/week for 5 or 7 weeks. Adverse effects observed in male rats included dose-related reductions in sperm count and viability and increases in deformed sperm and testicular lesions.

Supporting studies documented dose-dependent reductions in spermatogonia numbers in male rats, depletion of ovarian follicle pools in female mice, amenorrhea in female rats and impaired development of reproductive organs of offspring at maternally toxic doses in the rat.

Effects on developmental toxicity

Additional information

Based upon the available studies for toxicity to reproduction in combination with the human exposure observations, 2-bromopropane should be classified as Reproductive Toxicant Category 1A: Known Human Reproductive Toxicant as described in EC No 1272/2008, and labeling as R60 (May Impair Fertility) and R61 (May Cause Harm to the Unborn Child) is appropriate.

Justification for classification or non-classification

Additional information