Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 807-715-4 | CAS number: 1354569-12-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In accordance with REACH Article 18, testing is not required for this type of submission.
Classification and labelling are based on negative i) in vitro screening bioassays in human embryonic stem cells (Klimisch 2) and ii) a TOPKAT QSAR modelling .
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In accordance with REACH Article 18, testing is not required for this type of submission.
Short description of key information:
In accordance with REACH Article 18, testing is not required for this type of submission.
Effects on developmental toxicity
Description of key information
In accordance with REACH Article 18, testing is not required for this type of submission.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In accordance with REACH Article 18, testing is not required for this type of submission.
Toxicity to reproduction: other studies
Additional information
An in vitro human embryonic stem based devTOX Discovery assay and associated statistical models (metabolomics) were applied for predicting the potential for developmental toxicity. Exposure to bis(2-ethylhexyl) citraconate was made for three treatment levels (3, 30, and 300 μM). Based on these data, the compound did not show metabolic perturbation indicative of the potential to exhibit teratogenicity over the exposure range studied. In addition, the compound showed no cytotoxcity over the exposure range tested in either the dose ranging or metabolomics portions of the study. Only two significantly changed mass features were detected when treated cells were compared with DMSO controls, further indicating the compound exerts little impact on the growth and metabolism of hES cells. The study was conducted in accordance with Stemina's Standard Operating Procedures under non-GLP (non applicable OECD or EU test methods were yet available). The results are rated as Klimisch 2 and used as weight of evidence for classification and labelling and PBT assessment.
The extended TOPKAT QSAR model predicts the developmental toxicity potential of the test substance as negative with moderate confidence. An external expert assessment verifies that the 5 OECD principles for QSAR models validation are met. The prediction is therefore considered as Klimisch 2 and used as weight of evidence for classification and labelling and PBT assessment.
Conclusion:
Based on negative weight of evidence from in vitro screening assays on human embryonic cells and TOPKAT modelling results, there are no indications of reproductive toxicity of bis(2 -ethylhexyl)citraconate to humans.
Justification for classification or non-classification
In accordance with REACH Article 18, testing is not required for this type of submission.
Non-classification and labelling are based on negative weight of evidence from in vitro metabolomics study on human embryonic stem cells and TOPKAT QSAR modelling.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
