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Diss Factsheets
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EC number: 273-309-3 | CAS number: 68956-56-9
- 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
Key value for chemical safety assessment
Additional information
In two reverse gene mutation assays in bacteria with two different batches of the substance (low and high content of alcohols), performed according to the OECD guideline 471 and in compliance with GLP, the substance was negative in S. typhimurium strains (TA 1535, TA 1537, TA 98, TA 100 and TA 102) in presence and absence of metabolic activation, up to limit or cytotoxic concentrations.
The substance (batch with high content of alcohols) was also negative in presence and absence of metabolic activation in a chromosome aberration test performed in cultured human lymphocytes performed according to OECD guideline 473 and in compliance with GLP, except an ambiguous response in condition 20h exposure without S9. This result was counterbalanced by a clear negative result in in vitro micronucleus test in the same experimental conditions (20h exposure without S9) in the same test system (cultured human lymphocytes).
The substance (batch with high content of alcohols) was also negative in presence and absence of metabolic activation in a gene mutation test (HPRT) performed according to OECD guideline 476 and in compliance with GLP.
In a bone marrow micronucleus test, performed according to GLP and OECD guideline 474 with camphene, one of the main constituent of the substance, no statistically significant increases in the frequency of micronucleated PCEs or NCEs and PCE:NCE ratios were observed at any dose levels.
Justification for selection of genetic toxicity endpoint
No robust study summary was chosen for this endpoint because more than one study was used to complete this endpoint; therefore, it was not possible to select only one of the studies used for this endpoint.
Short description of key information:
The substance was found negative in the Ames test and the HPRT test. It was also negative in chromosome aberration test except an ambiguous response in condition 20h exposure without S9. However, this result was counterbalanced by a clear negative result in an in vitro micronucleus test in the same experimental conditions (20h exposure without S9) in the same test system (cultured human lymphocytes).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
As the registered substance is globally negative in all in vitro tests performed (mutagenicity in bacteria, mutagenicity in mammalian cells and clastogenicity tests) and as camphene is negative in an in vivo bone marrow micronucleus test, the susbtance is not classified for mutagenicity according to the annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) No.1272/2008.
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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