Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 270-887-9 | CAS number: 68480-11-5
- 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
Ames test (OECD TG 471): negative
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 May 2007 - 27 June 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- - S. typhimurium: Histidine gene
- E. Coli: Tryptophan gene - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- - Dose finding test 1:
TA 1535, TA 1537, TA 98, TA 100 and WP2uvrA (without and with S9): 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate
- Dose finding test 2:
Based on toxicity in dose finding test-1, the following dose levels were used in dose finding test-2:
TA 100, TA 1535, TA98, TA1537 (without and with S9) and WP2uvrA (without S9): 2.44, 4.88, 9.77, 19.5, 39.1 and 78.1 µg/plate
WP2uvrA (with S9): 9.77, 19.5, 39.1, 78.1, 156 and 313 µg/plate
- Main test:
Based on the results of dose finding test-1 and 2, following doses were used:
TA 100, TA 1535, TA98, TA1537 (without and with S9) and WP2uvrA (without S9): 2.44, 4.88, 9.77, 19.5, 39.1 and 78.1 µg/plate
WP2uvrA (with S9): 9.77, 19.5, 39.1, 78.1, 156 and 313 µg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: the test substance was insoluble in distilled water at 50 mg/mL and dissolved in DMSO at 50 mg/mL. The test substance solution of 50 mg/mL prepared with DMSO was considered to be stable from the facts that there was no change in color nor heat generation at room temperature within 2 hours after preparation. Therefore, DMSO was preferably selected as a solvent. - Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- furylfuramide
- other: ICR-191 and 2-Aminoanthracene
- Remarks:
- Use of a second indicator, next to 2-Aminoanthracene, of the efficacy of S9-mix is not mentioned in the report whlie required by the guideline. However, this is not expected to have influenced the study result.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Dose finding test-1, dose finding test-2 and main test: in agar (pre-incubation method)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:
- Duplicate plates per dose were used for the test substance treatment groups and the positive control groups.
- Triplicate plates were used for the negative control group.
DETERMINATION OF CYTOTOXICITY
- Method: bacterial growth inhibition - Evaluation criteria:
- The test substance was judged to be positive when the number of revertant colonies increased to twice or more that in the negative control in a concentration-dependent manner and also the reproducibility of the test results was obtained. In all ohter cases, it was judged to be negative.
- Statistics:
- Any statistical methods were not used.
- Key result
- Species / strain:
- other: S. thypimurium TA 100, TA 1535, TA 98, TA 1537 and E. coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test substance was not observed at any doses in the groups of with and without S9 mix.
DOSE FINDING TEST-1:
- The results of the dose finding test-1 showed that the number of revertant colonies in the test substance treatment groups was less than twice that in the solvent control. The bacterial growth inhibition was observed at 78.1 µg/pl or more in all test strains without S9 mix and in TA100, TA1535, TA98, TA1537 with S9 mix, and at 313 µg/pl or more in WP2uvrA with S9 mix. The precipitation of the test substance was not observed at any doses in the groups of with and without S9 mix.
DOSE FINDING TEST-2:
The results of the dose finding test-2 showed that the number of revertant colonies in the test substance treatment groups was less than twice that in the solvent control. The bacterial growth inhibition was observed at 39.1 µg/pl or more in TA 100, TA 1535, TA98 and TA 1537 without S9 mix, at 78,1 µg/pl in WP2uvrA without S9 mix and TA 100, TA 1535, TA 98 and TA 1537 with S9 mix, and at 156 µg/plate or more in WP2uvrA with S9 mix. The precipitation of the test substance was not observed at any doses in the groups of with and without S9 mix.
MAIN TEST:
The number of revertant colonies in the test substance treatment groups was less than twice that in the solvent control. The bacterial growth inhibition was observed at 39.1 µg/pl or more in TA 100, TA 1535, TA98 and TA 1537 without S9 mix, at 78,1 µg/pl in WP2uvrA without S9 mix and TA 100, TA 1535, TA 98 and TA 1537 with S9 mix, and at 156 µg/plate or more in WP2uvrA with S9 mix. The precipitation of the test substance was not observed at any doses in the groups of with and without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges.
ADDITIONAL INFORMATION:
- It was confirmed that the test system was free from bacterial contamination. - Conclusions:
- Under the conditions of this study the substance is not mutagenic.
- Executive summary:
The mutagenic activity of the substance was evaluated in a study according to OECD 471, according to GLP principles. The substance was tested in two dose finding tests and a main study using Salmonella thyphimurium strains TA 100, TA 1535, TA 98 and TA 1537 and Escherichia coli strain WP2uvrA using the pre-incubation method in the presence and absence of a metabolic activation system (S9 mix). Bacterial growth inhibition was observed at 39.1 µg/pl or more in TA 100, TA 1535, TA98 and TA 1537 without S9 mix, at 78,1 µg/pl in WP2uvrA without S9 mix and TA 100, TA 1535, TA 98 and TA 1537 with S9 mix, and at 156 µg/plate or more in WP2uvrA with S9 mix. Adequate negative and positive controls were included, though with S9 only one positive control is included, while two are preferred. This, however, is not thought to have impact on the study. The substance was judged to be negative because the number of the revertant colonies in the test substance treatment groups in all test strains was less than twice that in the negative control regardless of the presence or absence of S9 mix. Therefore it is concluded that the test substance had no ability to induce mutations under the present test conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The mutagenic activity of the substance was evaluated in a study according to OECD 471, according to GLP principles. The substance was tested in two dose finding tests and a main study using Salmonella thyphimurium strains TA 100, TA 1535, TA 98 and TA 1537 and Escherichia coli strain WP2uvrA using the pre-incubation method in the presence and absence of a metabolic activation system (S9 mix). Bacterial growth inhibition was observed at 39.1 µg/pl or more in TA 100, TA 1535, TA98 and TA 1537 without S9 mix, at 78,1 µg/pl in WP2uvrA without S9 mix and TA 100, TA 1535, TA 98 and TA 1537 with S9 mix, and at 156 µg/plate or more in WP2uvrA with S9 mix. Adequate negative and positive controls were included, though with S9 only one positive control is included, while two are preferred. This, however, is not thought to have impact on the study. The substance was judged to be negative because the number of the revertant colonies in the test substance treatment groups in all test strains was less than twice that in the negative control regardless of the presence or absence of S9 mix. Therefore it is concluded that the test substance had no ability to induce mutations under the present test conditions.
Justification for classification or non-classification
Based on the results of the Ames test, the substance does not have to be classified for mutagenicity in accordance with EU CLP and its amendments (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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.