Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Mode of Action Analysis / Human Relevance Framework

Additional information

Justification for classification or non-classification

Repeated oral toxicity:

An OECD guideline study (No. 415) was reported from BASF (2002). Male and female rats were given concentrations of 50, 200 and 800 ppm (= about 6, 21 and 77 mg/kg) over a study period of 18 weeks over the drinking water. No substance-related signs or any disturbance of behaviour was noted in all parental animals during the entire administration period. One high dose female was found dead during premating week 10. Erosions/ulcerations of glandular stomach mucosa was found at necropsy, but this was assessed as being not causative for death. No other mortalities occurred. The NOAEL was found to be 77 mg/kg/d for systemic toxicity for male and female parental animals. The NOEL was 21 mg/kg in this study, based on the reduced water and food consumption at the top dose level.

Classification according to Directive 67/548/EEC for repeated acute oral toxicity is not warranted.

Repeated inhalation toxicity:

BASF (1994) reported an OECD guideline 412 study. In this study, male and female rats were given vapour concentrations of 30, 100 and 300 ppm (= 0.10, 0.34 and 1.02 mg/l) over a study period of 28 days. The test substance was given for 6 hours each working day. Concentrations at or above 100 ppm (= 0.34 mg/l) caused irritation of the upper respiratory tract as demonstrated mainly by the concentration-dependent focal metaplasia of respiratory epithelium into squamous epithelium. No systemic toxic effects occurred up to the high concentration of 300 ppm. The NOAEC for systemic toxicity was 300 pm for both genders, the NOEC was 30 ppm (both sexes). The LOAEC for local irritation of the upper respiratory tract was found to be 100 ppm for male and female rats.

According to the effects found in this study, classification proposal according to Directive 67/548/EEC concerning repeated inhalation toxicity can be made with R 48.

No data ara available for repeated dermal toxicity.