Registration Dossier
Registration Dossier
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EC number: 807-715-4 | CAS number: 1354569-12-2
Carcinogenicity
Administrative data
Description of key information
In accordance with REACH Article 18, testing is not required for this type of submission. However, two QSAR models were conducted to support classification and labelling: i) DEREK model had a structural alert, which was assessed to be relevant for rodents only (Klimisch 4). ii) The equivocal result of the TOPKAT modelling was outside the domain and therefore not reliable (Klimisch 3).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with REACH Article 18, testing is not required for this type of submission.
Available very limited QSAR evidence from the DEREK modelling does not support human carcinogenicity classification.Additional information
Bis-(2-ethylhexyl)-citraconate had DEREK QSAR alert for Carcinogenicity as equivocal (alpha,beta-Unsaturated ester). Expert assessment concludes the carcinogenesis alert refers to a specific non-genotoxic mechanism involving repeat dose with local tissue damage (cytotoxicity) in rodent studies. It is concluded that this phenomenon has little or no relevance for human health, and the carcinogenic effect is rodent-specific. The reliability of the modelling is rated as Klimisch 4 (not assignable). Result is used as weight of evidence for classification and labelling and PBT assessment.
The TOPKAT model 4.5 carcinogenicity weight-of-evidence model predicted bis(2-ethylhexyl)citraconate as a non-carcinogen with a probability 0.50 and average similarity of 39 % with the four analogues. The liver tumours observed on rodent studies are most likely caused by peroxisome proliferation, and therefore not considered as relevant for humans. As the substance is outside the OPS domain, the result is rated as not reliable (Klimisch 3).
Conclusion:
Available very limited QSAR evidence from the DEREK modelling does not support human carcinogenicity classification.
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