Registration Dossier
Registration Dossier
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EC number: 807-715-4 | CAS number: 1354569-12-2
Endpoint summary
Administrative data
Description of key information
In accordance with REACH Article 18, testing is not required for this type of submission. There are two QSAR models conducted on repeated dose toxicity: i) DEREK Nexus model, rated as Klimisch 4, and ii) TOPKAT model (Klimisch 2) predicting a rat chronic LOAEL of 141 mg/kg. This was used as weight of evidence for classification and labelling and PBT assessment.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LOAEL
- 141 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- A QSAR rated as Klimisch 2.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bis-(2-ethylhexyl)-citraconate had DEREK alert for Peroxisome proliferation (Alkylalkane carboxylic acid or precursor) as doubted. The expert assessment concludes that the peroxisome proliferator alert refers to a hepatic effect only seen in rats, so it has no human health consequences. Chemicals that cause this effect it rats are seen to cause liver enlargement, with characteristic changes at the cellular level. The reliability of the result cannot be assigned (Klimisch 4).
The rat chronic LOAEL of 141 mg/kg bw was predicted using TOPKAT v 4.5 QSAR software. An external expert assessment rated the result as conclusive and verifies that the 5 OECD principles for QSAR models validation are met. The prediction is therefore considered as Klimisch 2 (reliable with restrictions) and used as weight of evidence for classification and labelling and PBT assessment.
Conclusion:
The rat chronic LOAEL of 141 mg/kg bw was predicted by QSAR modelling (Klimisch 2).
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
A QSAR modelling (A. Ruzgyte Frère 2016) predicts LOAEL of 141 mg/kg on rat.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
In accordance with REACH Article 18, testing is not required for this type of submission.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
In accordance with REACH Article 18, testing is not required for this type of submission.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
In accordance with REACH Article 18, testing is not required for this type of submission.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
In accordance with REACH Article 18, testing is not required for this type of submission.
Justification for classification or non-classification
In accordance with REACH Article 18, testing is not required for this type of submission.
Bis(2 -ethylhexyl) citraconate is not classified regarding repeated dose toxicity, as the predicted LOAEL 141 mg/kg exceeds the lowest classification limit of the CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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