Registration Dossier
Registration Dossier
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EC number: 203-703-2 | CAS number: 109-77-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Ames-Test:
The test material showed toxic efficacy in the presence and in the absence of metabolic activation at the concentration of 5000 MCG per plate, so that an evaluation of the potential mutagenic activity was prevented at this dose.
Up to the highest evaluted dose 1580 MCG per plate +/- activation system, no relevant increase of the revertant colony numbers was obtained in any strain in comparison with the corresponding controls.
In conclusion, no gene mutagenic activity could be demonstrated under the experimental conditions.
CA-Test:
The test compound dose levels for analysis were selected by determining mitotic indices from a broad range of doses up to 5000 MCG/ml.
It is concluded that Malononitrile was able to induce chromosome aberrations in cultured human lymphocytes both in the absence and presence of S-9 when tested to its limit of toxicity.
Micronucleus-Test:
Malononitrile did not induce chromosomal or other damage leading to micronucleus formation in polychromatic erythrocytes in the bone marrow of mice treated once by the oral route and killed 24, 48 or 72 hours later.
The test procedure was highly sensitive to the chromosome-damaging action of chlorambucil.
Short description of key information:
Ames test (in vitro): according to OECD 471
Salmonella Thyphimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538
With and without liver microsomal activation
Eight concentration: 1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 and 5000 MCG per plate, each compound concentration including controls was tested in triplicate.
CA-test (in vitro): according to OECD 473
Malononitrile was tested in an in vitro cytogenetics assay using duplicate human lymphocyte cultures from a single male donor. +/- metabolic activation by a rat liver postmitochondrial fraction (S-9) from Aroclor-1254 induced animals.
Micronucleus-Test (in vivo): according to OECD 474
The effect of Malononitrile on chromosome structure in bone marrow cells was investigated following acute oral administration to mice. Chromosome damage was measured indirectly by counting micronucle.
Dose: 2.5, 5, 10 and 20 mg/kg
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Ames-test - negative
CA-test - positive
Micronucleus-test - negative
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