Registration Dossier
Registration Dossier
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EC number: 287-836-1 | CAS number: 85586-34-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Studies were carried out on the read-across substance, ESBO.
No evidence for the induction of reverse mutation was seen in an Ames test performed in S. typhimuriumstrains TA 98, TA 100, TA 1535, TA 1537 and TA 102) at concentrations up to the limit of 5000 µg/plate in the absence and presence of metabolic activation. A non-guideline test was also carried out on TA 98, TA 100, TA 1535, TA 1537 and was also negative.
No evidence for the induction of micronuclei was seen in a study performed in cultured primary human peripheral lymphocytes in the absence and presence of metabolic activation at the limit of solubility (55 µg/mL).
No evidence for the induction of forward mutation was seen in a mouse lymphoma assay performed in L5178Y cells in the absence and presence of metabolic activation and at highest dose concentrations of 5000 µg/mL.
A mammalian mutation assay (CHO/HGPRT) is also available. This study was conducted prior to the adoption of the test guideline. It was concluded that the substances (ESO and chlorinated ESO) were non-mutagenic in CHO cells under the test conditions.
The available data in in vitro studies demonstrate the absence of genotoxicity for soybean oil, epoxydised, ether with ethylene glycol.
Justification for selection of genetic toxicity endpoint
A weight of evidence appraoch is followed for this endpoint: no key study is identified
Short description of key information:
The genotoxicity of the read-across substance ESBO has been investigated in an appropriate battery of studies in vitro.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification for genotoxicity is proposed, based on the clear negative results obtained in an appropriate battery of studies in vitro.
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