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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 265-779-3 | CAS number: 65443-14-3
- 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:
Existing human data (HRIPT, Biotest, 1978) concluded that the registered substance has no skin sensitization potential at 10% in White petrolatum. However, the reliability of those data on its own was not considered adequate to meet the REACH requirements and to make a conclusion on classification and labelling.
Therefore, a weight-of evidence approach using the HRIPT result, the GPMT result on the supporting substance (2-pentylcyclopentan-1-ol, see IUCLID section 13 for read-across justification), and two QSARs, which was considered sufficiently robust to conclude on the skin sensitisation potential of the substance.
The GPMT study on 2-pentylcyclopentan-1-ol (Toxicol, 1995, rel.2) was performed according to the OECD test guideline no. 406 and in compliance with GLP using the Guinea-Pig Maximisation Test method (20 treated animals + 10 controls).
The test material (in 1:1 mixture of Freund’s Complete Adjuvant and water) diluted in light liquid paraffin at 5% (v/v) was administered by injection for intradermal induction. As the substance was not a skin irritant, 24 hours prior to the topical application, the site was pre-treated with 10% w/w sodium lauryl sulphate in light liquid paraffin. Topical induction was performed with the test material as supplied, 7 days after intradermal injections. For the challenge, 21 days after study initiation, the test material was tested undiluted.
One test animal was killed in extremis on the day of patch removal following topical induction and was found to have a prolapsed uterus following a post-mortem examination.
Following challenge, none of the remaining 19 test animals responded positively at the 24 or 48 hour observations, resulting in a response incidence of 0 %. Similarly, none of the 19 animals responded positively to challenge with the vehicle.
The historical positive control, hexyl cinnamic aldehyde, produces evidence of skin sensitization in 8 of 10 animals at 50 %, resulting in a response incidence of 80 %. These results confirmed that hexyl cinnamic aldehyde is a sensitizer under the conditions of this study and the test system was therefore considered to be validated.
Under the test conditions, the supporting substance is not a skin sensitizer.
Both the OECD QSAR Toolbox and ToxTree did not show any alert for protein binding with the substance.
Based on the whole data, it can be concluded that the substance is not a skin sensitizer.
Migrated from Short description of key information:
Skin sensitisation: Not sensitising, WoE (GPMT data on a supporting substance, HRIPT, QSARs)
Justification for selection of skin sensitisation endpoint:
No key study was selected since all studies were used within a weight-of-evidence approach.
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.
Self-classification:
Based on the available information, no additional self-classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP.
No information is 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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