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EC number: 261-629-6 | CAS number: 59151-19-8
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 February to 23 March 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- rel-(1R,6S)-ethyl 2-methyl-4-oxo-6-pentylcyclohex-2-enecarboxylate
- Molecular formula:
- C15H24O3
- IUPAC Name:
- rel-(1R,6S)-ethyl 2-methyl-4-oxo-6-pentylcyclohex-2-enecarboxylate
- Reference substance name:
- rel-(1R,6R)-ethyl 2-methyl-4-oxo-6-pentylcyclohex-2-enecarboxylate
- Molecular formula:
- C15H24O3
- IUPAC Name:
- rel-(1R,6R)-ethyl 2-methyl-4-oxo-6-pentylcyclohex-2-enecarboxylate
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Test material name (as stated in the report): Calyxol
- Batch No. 748444534002
- Sanple received on 13 February 2007
- Storage: Room temperature in the dark
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver
- Test concentrations with justification for top dose:
- Salmonella strains: 5, 15, 50, 150, 500, 1500 and 5000 microg/plate (determined in a preliminary toxicity assay)
E.Coli strain WP2uvrA: 50, 150, 500, 1500 and 5000 microg/plate (determined in a preliminary toxicity assay) - Vehicle / solvent:
- Dimethyl Sulphoxide
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA1535, TA1537, TA98, TA100 and WP2uvrA-
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- TA1535 in presence of S9 at and above 1500 microg/plate in both range fiding and main tests
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The test material caused a visible reduction in the growth of the bacterial background lawn of Samonella Typhimurium strains TA100 and TA1537 (absence of S9 only) and TA1535 (presence and absence of S9), initally from 500 to 1500 microg/plate in the absence and presence of S9, respectively. No weakening of the bacterial background lawns were noted for any of the remaining bacterial strains. The sensitivity of the bacterial tester strain to the toxicity of of the test material varied slightly between strain type, exposures with and without S9 and Experiment number. The test material was, therefore, tested up to the maximum recommended dose level of 5000 microg/plate.
No significant increases in the frequency of the revertant colonies were recorded for any of the bacterial strains with any dose of the test material, either with or without matabolic activation.
Applicant's summary and conclusion
- Conclusions:
- The test material was considered to be non-mutagenic under the conditions of this test, Calyxol does not met the criteria for mutagenic classication according the CLP Regulation (EC) No. 1272/2008.
- Executive summary:
Samonella Typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia Coli strain WP2uvrA- were treated with the test material using the Ames plate incorporation method at up to seven dose levels, in triplicate, both with and without the addition of rat liver homogenate metabolising system (10% liver S9 in standard co factors). The dosage range for the range finding test was determined in a preliminary toxicity assay and was 5 to 5000 microg/plate and 50 to 5000 microg/plate for the Samonella Typhimurium and Escherichia Coli strain WP2uvrA-, respectively. The experiment was repeated on a separate day using an amended dose range, fresh cultures of the bacterial strains and fresh test material formulations.
Additional dose levels were included for the Samonella Typhimurium strains to allow for the test metarial induced toxicity, ensuring that at least four non toxic doses were archived.
The test material caused a visible reduction in the growth of the bacterial background lawn of Samonella Typhimurium strains TA100 and TA1537 (absence of S9 only) and TA1535 (presence and absence of S9), initally from 500 to 1500 microg/plate in the absence and presence of S9, respectively. No weakening of the bacterial background lawns were noted for any of the remaining bacterial strains. The sensitivity of the bacterial tester strain to the toxicity of of the test material varied slightly between strain type, exposures with and without S9 and Experiment number. The test material was, therefore, tested up to the maximum recommended dose level of 5000 microg/plate.
No significant increases in the frequency of the revertant colonies were recorded for any of the bacterial strains with any dose of the test material, either with or without matabolic activation.
The test material was considered to be non-mutagenic under the conditions of this test.
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