Registration Dossier
Registration Dossier
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EC number: 240-596-1 | CAS number: 16529-56-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Reverse gene mutation assay
Only one study is available and is considered as a key study ( Reynolds, 1991). In a reverse gene mutation assay in bacteria performed according to the OECD test guideline No. 473 and in compliance with GLP, strains TA 1535, TA 97, TA 98 and TA 100 ofS. typhimuriumwere exposed to 2 -methyl - 3 - butenenitrile (97.2% pure) in DMSO at concentrations of 0, 10, 50, 100, 500, 1000, 2500 and 5000 µg/plate in the presence and absence of mammalian metabolic activation (S-9 mix from male Crl:CD rat injected i.p. with Aroclor 1254).There was no evidence of induced mutant colonies over background in this study. Therefore, 2 -methyl - 3 - butenenitrile is not mutagenic in bacteria.
In vivo data
In a genetic toxicity in vivo study, a micronucleus assay was performed on male swiss mice. 2 -methyl-3 -butenenitrile was admistered by gavage twice at 24 -hours interval at dose concentration of 0.01 and 0.05 mL/kg. Arachis oil was used as vehicle.
This study was performed equivalent to OECD Guideline 474, but with no GLP compliance. A preliminary study was performed to determine dose.
Animals were sacrified 6 hours after the second administration of 2 -methyl-3 -butenenitrile. Polychromatophyle erythocyte sampling was performed in the femur. 2000 cells were coloured with May Grünwald-Giemsa and analysed for micronuclei. Positive control (benzene) and negative control (vehicle) were valids.
Only the percentage of micronuclei in polychromatic erythrocytes is determined. There is no information concerning proportion of immature erythrocytes among total erythrocytes and the accessibility of the product to the bone marrow. The cytotoxicity of the product is missing. There are several other deviations. Therefore no conclusion can be established (Kr:3)
Short description of key information:
Bacterial reverse mutation assay / Ames test: S. typhimurium TA 1535, TA 97, TA 98 and TA 100: negative with and without metabolic activation.
micronucleus assay: due to the bad quality of the study, no conclusion can be established.
Endpoint Conclusion:
Justification for classification or non-classification
Based on these studies (cited above), no classification can be established due to a lack of data.
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