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Diss Factsheets
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EC number: 810-495-2 | CAS number: 93452-03-0
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No study was available on the substance itself, therefore a read-across approach was used. The supporting substance is considered adequate for read-across purpose as data relates to a mixture of cis- and trans-isomers whereas the registered substance is the pure cis-isomer (see Iuclid section 13 for additional justification).
Two skin sensitisation studies were identified on the supporting substance. Although these studies provided information to assess the skin sensitisation potential of the registered substance, none of them was considered as sufficient to be the key study on its own. Therefore, a weight-of-evidence approach was built:
- A Local Lymph Node Assay (LLNA, BRT, 2004, Rel.2)) was performed in compliance with GLP and similarly to the OECD test guideline No. 429 and in compliance with GLP. A significant lymphoproliferation was noted in the positive control group, therefore the study was considered valid. The test material (1%-40%) did not induce delayed contact hypersensitivity in this assay. None of the mice assigned to this study experienced visible irritation or other adverse toxic effects. In this study, the maximum concentration tested was not justified: a screening study was not performed and ear thickness measurements were not included.
- A Guinea-Pig Maximisation test (GMPT, Instituto di Recerche Biomediche, 1995, Rel.2) was performed according to the OECD test guideline No. 406 and in compliance with GLP. The test material, diluted in paraffin oil at 6.25% (v/v), was administered by injection for intradermal induction. Topical induction was performed with the test material as supplied, 7 days after intradermal injections. For the challenge, the test material was tested at 100% and 50% v/v in paraffin oil. There were no responses apparent in the treated and control groups. Under the test conditions, the test material is not classified as skin sensitizer. This study does not include positive control data, the sensitivity and the reliability of the method cannot be ascertained.
The registered substance is present at 25 -30% in the mixture, i.e. well above the concentration triggering classification of mixture as skin sensitizer as defined in the Annex VI of the Regulation (EC) No. 1272/2008, therefore it can be safely concluded that the pure cis-isomer does not need to be classified as skin sensitizer.
Migrated from Short description of key information:
- LLNA, Not sensitising (similar to OECD 429, GLP, read-across, WoE, Rel.2);
- GPMT, Not sensitising (OECD 406, GLP, read-across, WoE, Rel.2).
Justification for selection of skin sensitisation endpoint:
No study was available on the substance itself, therefore a read-across approach was used. The supporting substance is considered adequate for read-across purpose as data relates to a mixture of cis- and trans-isomers whereas the registered substance is the pure cis-isomer (see Iuclid section 13 for additional justification). No study was selected as Key since a weight-of-evidence approach using the LLNA and the GPMT assay on the supporting substance was considered more robust.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP4.
Self-classification:
Based on the available data on the supporting substance, no additional self-classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EC.
No data was available regarding respiratory sensitisation.
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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