Registration Dossier

Administrative data

Key value for chemical safety assessment

Justification for classification or non-classification

BASF (2002) reported an 1-generation study done with OECD guideline 415. Male and female rats were given 6, 21 and 77 mg/kg bw via the drinking water. No substance-related adverse effects in all three dose groups were found. The NOAEL was 800 ppm (= 77 mg/kg/bw/d) concerning reproductive performance and fertility, systemic toxicity and developmental toxicity for the F0 parental rats and their progeny. The NOEL was found to be 200 ppm (= 21 mg/kg/d) for the parental animals.

Classification concerning reproduction toxicity is not warranted.

3-methyl-2-butenal was tested in a prenatal developmental toxicity study (BASF, 2002). Rats were given orally (gavage) doses of 50, 150 and 450 mg/kg from day 6 to day 19 p.c. The test substance was already lethal for the dams at 450 mg/kg, evoked only transient salivation in nearly all 300 mg/kg females and in a few 150 mg/kg dams, and did not induce any effect on the females at 50 mg/kg. The administration had no effects on the gestational parameters and induced no signs of prenatal developmental toxicity, in particular no indications for teratogenicity at dose leevls, where fetuses for further assessment were available. The NOAEL for fetotoxicity was 300 mg/kg, the NOAEL for embryotoxicity was found to be 300 mg/kg, the NOAEL for maternal toxicity was 300 mg/kg and the NOAEL for teratogenicity was found to be 300 mg/kg.

Classification regarding developmental toxicity is not warranted.