Registration Dossier
Registration Dossier
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EC number: 243-296-9 | CAS number: 19780-11-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
n-Dodecenyl succinic anhydride (n-DDSA) has been tested in a guideline bacterial reverse mutation assay (both plate incorporation method and preincubation method) and found to be negative (not mutagenic). Other members of the C8-12 Alkenyl Succinic Anhydride category (tetrapropenyl succinic anhydride, octenyl succinic anhydride, and tripropenyl succinic anhydride) have also been nonmutagenic in the Ames assay. Tripropenyl succinic anhydride was tested in a guideline chromosomal aberrations assay and mammalian mutation assay (mouse lymphoma assay), and was found to be negative. An in vivo Unscheduled DNA Synthesis (UDS) assay on tripropenyl succinic anhydride was negative. In the review by the World Health Organization of Cyclic Acid Anhydrides (CICAD 75, 2009), genotoxicity tests for a variety of category members were negative for genotoxicity. These data indicate that the alkenyl succinic anhydrides are not genotoxic.
A category approach is used for the hazard assessment of several endpoints. The hypothesis for the category of C8-12 Alkenyl Succinic Anhydrides is that data can be read-across among members of the category because their properties and behaviours are similar, based on common functional groups and similar breakdown products, and based on a constant pattern in changing of the potency of properties of the various carbon chain lengths. Functional groups include a dihydro-2,5 -furandione cyclic anhydride ring, a carbon chain of length 8 -12 carbons, and a single double-bond within the carbon chain. The primary functional group associated with toxicity is the succinic anhydride moiety, which quickly is hydrolysed to form a butanedioic acid. A constant pattern may also be displayed in acute toxicity, dermal irritancy and biodegradation, with the lowest carbon chain length (C8) displaying the highest activity. Irritation, toxicity and degradation potential diminish with increasing carbon chain length. Read-across among the category members is substantiated by the common behaviour in physico-chemical and toxicity behaviours, as provided in the Chemical Category Report Format (CCRF) attached to the IUCLID file. It is adequate to fulfill the information requirements of Annex IX, to be the basis for classification and labelling decisions, and for risk assessment.
Justification for selection of genetic toxicity endpoint
Guideline study under GLP
Short description of key information:
The substance has been tested in a guideline bacterial reverse mutation assay and found to be negative (not mutagenic). Other members of the C8-12 Alkenyl Succinic Anhydride category have also been nonmutagenic in in vitro genotoxicity tests. The conclusion is that the substance is not genotoxic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
This substance does not meet the criteria for mutagenicity in Regulation EC No. 1272/2008.
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