Registration Dossier
Registration Dossier
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EC number: 800-766-3 | CAS number: 1424148-97-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Justification for the read-across approach using (Tetrapropylensuccinimido)-caproic acid as supporting substance:
The acid form of the registration substance and proposed supporting substance (Tetrapropylensuccinimido)-caproic acid are homolog series of (Polypropylensuccinimido)-caproic acid. The only structural difference is that the alkyl moiety of the registratoin substance is composed of five propylen unit, whereas that of the supporting substance is composed of four propylen unit. The given structural difference is not likely to be associated with significantly deviating genotoxicity potential, because significantly different chemical reactivities cannot be expected.
Evaluation of the genotoxicity of the registration substance
The read-across supporting substance is not mutagenic in Ames test, not mutagenic in HPRT test. It is however clastogenic in in-vitro chromosome aberration test and not clastogenic in in-vivo chromosme aberration test.
The observed clastogenicity in in-vitro assay may be related to the highly branched alkyl moiety that may be able to form stabilized radical species. This property is certainly linked to the technical profile in that the substance is used as corrosion inhibitor. In the in-vivo chromosome aberration assay no clastogenic acitivity was found in the bone marrow of orally treated animals. The study is valid, since cytoxicity was found in the bone marrow cells, demonstrating that the bioavailbility to the bone marrow cells was given. Overall, no significant genotoxicity can be assigned for the read-across supporting substance based on the available data.
Likewise no significant genotoxicity property can be derived for the registration substance.
Justification for selection of genetic toxicity endpoint
Four studies are available and all studies are equally valid.
Short description of key information:
No significant genotoxicity property can be derived for the registration substance.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The overall genotoxicity is assessed to be of no concern.
No classification is warranted.
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