Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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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
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.
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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