Registration Dossier

Administrative data

Description of key information

The key repeated dose oral toxicity study (HSDB 2002 citing Jeong 2002), which was not conducted in accordance with the applicable OECD Guideline or GLP, showed immunitoxicity to cells in the male rat spleen and thymus at 1,000 mg/kg bw/day (LOAEL) 2-bromopropane ingested daily for 28 consecutive days.   No adverse effects were observed at 330 mg/kg bw/day (NOAEL) during the same exposure period.
The key repeated dose inhalation toxicity study (JBRC 1999), which was conducted according to OECD 422 and to GLP, showed decreases in male testis weight in the rat following 6-hour daily exposure to 2-bromopropane for 14 consecutive days at a vapour concentration of 1,000 ppm (LOAEC). No adverse effects were observed at 500 ppm (NOAEC) during the same exposure period.
Supporting documentation from genetic toxicity and toxicity to reproduction studies indicated that repeated exposure to 2-bromopropane resulted in adverse effects.

Key value for chemical safety assessment

Additional information

For repeated dose oral and inhalation toxicity, the most recent reliable study was selected as the key study.

Justification for classification or non-classification

Based upon the available studies for repeated exposures via ingestion and inhalation, 2-bromopropane does not require classification as STOT-RE Category 1 or 2 as described in EC No 1272/2008, because the LOAEL and LOAEC determined in the key studies were higher than the guideline value ranges. Labeling as R48/20 (Harmful: Danger of Serious Damage to Health by Prolonged Exposure Through Inhalation) is appropriate based upon the body of evidence.