Registration Dossier
Registration Dossier
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EC number: 816-856-0 | CAS number: 5205-01-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Under the requirements of REACh Annex VII the genotoxicity assessment is restricted to an in vitro gene mutation study in bacteria. When tested in vitro, 3-methyl-1,3-butanediol acetate (IPD-AC) was negative in an Ames test. I
It was concluded that IPD-AC did not induce mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) ofSalmonella typhimuriumwhen tested under the conditions of this study. These conditions included treatments at concentrations up to 5.0 µL/plate (the maximum recommended concentration according to current regulatory guidelines) in the absence and in the presence of a rat liver metabolic activation system (S9), utilising plate incorporation and pre-incubation methodologies.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Under the requirements of REACh Annex VII the genotoxicity assessment is restricted to an in vitro gene mutation study in bacteria.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
Under the requirements of REACh Annex VII the genotoxicity assessment is restricted to an in vitro gene mutation study in bacteria. When tested in vitro, IPD-AC was negative in an Ames test.
Additional information
Justification for classification or non-classification
Comparison with the CLP criteria
There was no indication that IPD-AC has a mutagenic effect in the in vitro bacterial (reverse) gene mutation assay. However, no data were available with respect to the germ cell mutation potential of IPD-AC in human cells. Therefore, criteria for classification for germ cell mutagenicity could not be met based on data lacking.
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