Registration Dossier
Registration Dossier
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EC number: 500-109-8 | CAS number: 43011-20-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In genetic toxicity in vitro studies, the substance and a structurally-similar category member (ZAN 573, 5 -isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol) were found to be negative (non-mutagenic and non-clastogenic).
A category approach is used for the assessment of this endpoint. The hypothesis for the category of cyclic acid anhydrides is the similar chemical behaviour and analogous breakdown products in environmental and biological systems. The common functional group is a 1,3-dioxo-1,3-dihydro-2-furan ring (i. e., a cyclic acid anhydride) directly attached to an aromatic ring. The cyclic anhydride moiety is quickly hydrolysed to form a dioic acid. The cyclic acid anhydride moiety and its dioic acid derivatives are the principal loci of toxicity, rather than the remainder of the molecule. Within the category, oligomeric forms of the cyclic acid anhydrides are less likely to be absorbed across biological membranes than the simple, monomeric forms, so that this read-across represents the worst case scenario. The read-across information to acceptable to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling.
Justification for selection of genetic toxicity endpoint
experimental result
Short description of key information:
The substance and a structurally-similar category member were nongenotoxic in studies in vitro.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The substance and a structurally-similar category member were nongenotoxic in studies in vitro, and do not meet the criteria for classification according to Regulation EC No. 1272/2008.
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