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EC number: 945-920-1 | CAS number: -
- 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
Genetic toxicity in vitro
Description of key information
The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay, performed according to OECD 471 and GLP principles.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 15, 2003 - June 05, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD guideline and according to GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2000/32/EC, L1362000, Annex 4D, dated May 19, 2000
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): VERNALDEHYDE
- Description: colourless to pale yellow liquid
- Lot/batch No.: 9000505038
- Expiration date of the lot/batch: August 27, 2003
- Storage condition of test material: approx. 4°C - Target gene:
- - S. typhimurium: Histidine gene
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- Preliminary test (without and with S9) all 5 strains: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment 1 (without and with S9) TA1535, TA1537, TA98, TA100 and TA102 (without S9): 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment 1 TA102 (with S9): 3, 10, 33, 100, 333 and 1000 µg/plate
Experiment 2 (without and with S9) all 5 strains: 33, 100, 333, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO was chosen because of its solubility properties and its relative nontoxicity to the bacteria. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: methyl methane sulfonate in water deionised 4.0 µL/plate for TA102
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine in DMSO, 10 µg/plate for TA98 and 50 µg/plate for TA1537
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide in water deionised, 10 µg/plate for TA100 and for TA1535
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene in DMSO, 2.5 µg/plate for TA98, TA100, TA1535, TA1537 and 10 µg/plate for TA102
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: exp.1 in agar (plate incorporation); exp.2 preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hour
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: no data
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA98, TA100 and TA102) or thrice (strains TA1535 and TA1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such as an increase is not considered biologically relevant. - Statistics:
- Not required.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp.1: TA1537 without S9 at 5000 µg/plate and TA102 with S9 at 333 and 1000 µg/plate. Exp.2: TA1537 without S9 at 333 µg/plate and with S9 at 1000-5000 µg/plate, TA1535 with S9 at 5000 µg/plate and TA100 with S9 at 1000 µg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES:
- No toxicity or mutagenicity was observed up to and including the top dose of 5000 µg/plate. Except in strain TA102 with S9, toxicity was observed at the dose of 333 µg/plate and above.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The historical control data in experiment 1 were slightly above the historicalcontrol range in strain TA98 (with S9, negative control) and TA100 (with S9, negative and solvent control). Since these deviations are rather small, these effects are considered to be based upon biologically irrelevant fluctuations in the number of colonies and have no detrimental impact on the outcome of the study.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Exp.1: TA1537 without S9 at 5000 µg/plate and TA102 with S9 at 333 and 1000 µg/plate.
Exp.2: TA1537 without S9 at 333 µg/plate and with S9 at 1000-5000 µg/plate, TA1535 with S9 at 5000 µg/plate and TA100 with S9 at 1000 µg/plate. - Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay, performed according to OECD 471 and GLP principles.
- Executive summary:
The genetic toxicity of the substance was assessed using Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 strains, in accordance with OECD 471 guideline and GLP principles. No precipitation was observed up to and including the top dose of 5000 µg/plate. Slight toxicity was observed in several strains.
All bacterial strains showed negative responses over the entire dose range, i.e. no biologically significant dose-related increase in the number of revertants in two independently repeated experiments with and without metabolic activation up to the highest concentration of 5000 µg/plate. Based on the results it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-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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