Registration Dossier
Registration Dossier
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EC number: 219-144-2 | CAS number: 2372-45-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
As sodium butanolate is a highly unstable substance and hydrolysis can already be expected at air humidity, in vitro genotoxicity testing is not feasible.
Therefore, data from the hydrolysis products NaOH and n-Butanol are used to assess the potential for genetic toxicity of sodium butanolat in vitro.
The in vitro genetic toxicity tests with NaOH, CAS 1310-73-2, indicated no evidence of mutagenic activity. According to the REACH Regulation, further mutagenicity studies shall be considered in case of a positive result (column 2, Annexes VII, VIII). Therefore, further testing for mutagenicity is not relevant for NaOH. In vivo genetic toxicity tests with NaOH, CAS 1310-73-2 indicated no evidence for a mutagenic activity. Futhermore NaOH is not expected to be systemically available in the body under normal handling and use conditions (EU RAR, 2007; section 4.1.2.6.3, page 72). Therefore, additional testing is considered unnecessary.
Under the experimental conditions reported the test item n-butanol did not induce gene mutations at the HPRT locus in V79 cells.
n-Butanol did not induce chromosomal aberrations in an in vitro mammalian cell micronucleus test with V79 cells.
In none of the treatments of an Ames test, the maximum revertant factor exceeded a value of 1.5, indicating that the test substance n-butanol is not mutagenic in the Ames test under the tested conditions.
n-Butanol does not have any chromosome-damaging (clastogenic) effect, and there were no indications of any impairment of chromosome distribution in the course of mitosis in a micronucleus assay in vivo.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Existing data of the hydrolysis products of sodium butanolat (NaOH and n-Butanol) do not demonstrate any genotoxic or mutagenic properties.
Since hydrolysis of sodium butanolat occures immediately at air humidity, the properties of the hydolysis products can be used to derive its genetic toxicity potential. Therefore, sodium butanolate is considered not to be genotoxic and mutagenic.
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