Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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.
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.