Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Endpoint Conclusion:

Justification for classification or non-classification

In vitro:

BASF (1991) found a positive result when tested 3-methyl-2-butenal in an Ames test. Concentrations used were 20, 100, 500, 2000, 2500, 3000, 4000, 5000 and 6000 ug/plate with and without metabolic activation. This test was done according to Ames et al. (1973).

In an older BASF study (1979) a negative Ames test result was obtained. Concentrations ranged from 4 - 2500 ug/plate with and without metabolic activation. Also, this test was done according to Ames et al. (1973).

In vivo:

An unscheduled DNA synthesis test done with OECD guideline 486 (BASF, 2001). Male rats were given doses of 350 and 700 mg/kg as a single application (gavage). 3-methyl-2-butenal did not induce DNA damage as evidenced by the negative result in the UDS assay when given to rats in sublethal doses which led to clear signs of acute toxicity. Cell viability and cell morphology were not affected by the treatment.

BASF (1992) reported a micronucleus test (according to OECD guideline 474). No clastogenicity and no impairment of chromosome distrubion was found in this study. 3-methyl-2-butenal was given as a single treatment to male and female mice via gavage. Doses tested were 175, 350 and 700 mg/kg.

Since both in vivo studies showed negative results, classification regarding genotoxicity is not necessary.