Registration Dossier
Registration Dossier
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EC number: 248-580-6 | CAS number: 27619-97-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro gene mutation study in bacteria -OECD 471; Ames mutation in S. typhimurium. Negative. Reliability = 1.
In vitro cytogenicity / chromosome aberration study in mammalian cells- OECD 473; Chromosome aberrations in CHO.Positive for the induction of structural chromosome aberrations in cells treated 4-hours in the presence and absence of metabolic activation. Negative for the induction of structural chromosome aberrations in cells treated 20-hours in the absence of metabolic activation. Negative for the induction of numerical chromosome aberrations in cells under all exposure conditions. Reliability = 1
In vivomammalian somatic cell studyOECD 475; bone marrow chromosome aberrations in mouse. Negative. Reliability = 1.
In vivomammalian somatic cell study: OECD 474;bone marrow micronucleus induction in mouse.Negative. Reliability = 1.
In vivomammalian somatic cell study: OECD 486, DNA repair (UDS) in liver of rat. Negative. Reliability = 1.
In vivomammalian somatic cell study: OECD 489, DNA damage (Comet) in liver and stomach of rat. Negative. Reliability = 2.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The test substance was negative for mutagenicity in bacterial cells. It was positive for the induction of structural and negative for the induction of numerical chromosome aberrations in mammalian cell culture. In vivo, the test substance was negative by two measures of clastogenicity, micronucleus and chromosome aberrations. Genetoxicity also proved negative in two additional in vivo tests, induction of DNA repair by the test substance, and DNA damage by a structural analogue. Based on an assessment of the robust genetic toxicity data for this substance and its structural analogue, the substance does not need to be classified for mutagenicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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