Registration Dossier
Registration Dossier
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EC number: 943-366-5 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Acetic anhydride (Ames, WoE.1)
No evidence of mutagenicity in the Ames test (bacteria), with and without activation (McMahon et al., 1979). Results in the mouse lymphoma gene mutation assay were equivocal without metabolic activation and not mutagenic with metabolic activation. The equivocal result may be due to acidification of the culture medium. (OECD; SIDS, 1997).
Acetic acid (Cytogenicity, WoE.2; Ames, WoE.3, WoE.5)
Acetic acid in concentrations of 100–6 666 μmole/plate with and without metabolic activation was negative in mutagenicity assays using Salmonella typhimurium strains TA97, TA98, TA100 and TA1535 (Zeiger et al 1992). Acetic acid was non-mutagenic in the Ames assay at concentrations of up to 10 mg/plate with metabolic activation (Ishidate et al., 1992). Acetic acid at concentrations close to those showing cytotoxicity (up to 16 mM) was concluded not to be clastogenic when tested in cultured Chinese hamster K1 cells; the observed induction of chromosome aberrations were considered to be due to pH-effects (Morita, 1990).
Adipic acid (Ames, WoE.4)
Adipic acid was not mutagenic in the Ames test in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 or in Escherichia coli (WP2(uvrA)) with or without rat microsomal activation. (Shimizu et al., 1985).
Justification for selection of genetic toxicity endpoint
As WoE approach was used for assessment no single study was selected
Short description of key information:
Acetic anhydride:
Ames test (OECD 471): Non-mutagenic with or without metabolic activation (McMahon et al., 1979).
Mouse lymphoma mutagenesis assay: Negative with metabolic activation and equivocal response without metabolic activation (OECD; SIDS, 1997).
Acetic acid:
Ames test (OECD 471): Non-mutagenic with metabolic activation (Ishidate et al., 1984).
Ames test (OECD 471): Non-mutagenic with metabolic activation (Zeiger et al., 1992).
Mammalian in vitro cytogenicity test (OECD 473): Negative with or without metabolic activation (Morita et al., 1990).
Adipic acid:
Ames test (OECD 471): Non-mutagenic with metabolic activation (Shimizu et al., 1985).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the genetic toxicity studies available of the components of the target substance the target substance will not be classified for germ cell mutagenicity in accordance with the criteria of CLP Regulation 1272/2008.
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