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EC number: 608-408-6 | CAS number: 29736-24-1
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 19, 2009 - June 19, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-guideline study: The study was conducted in accordance with hte following guidelines: OECD-guidelines for the testing of chemicals Part 471, adopted July 21, 1997 "Bacterial Reverse Mutation Test" and EU-Guideline B.13/14 adopted may 31, 2008 "Mutagenicity-Salmonella typhimurium reverse mutation assay"
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
- Target gene:
- Five genetically manipulated strains of Salmonella typhimurium (TA 97a, TA 98, TA 100, TA 102 and TA 1535) were exposed to the test item.
plate incorboration method (first experiment)
pre-incubation method (second and third experiment)
Species / strainopen allclose all
- Species / strain / cell type:
- other: TA97a
- Additional strain / cell type characteristics:
- other: hisD6610, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: hisD3052, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: hisG428, pKM 101, rfa
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: hisG46, uvrB, rfa
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- First Experiment:
Five concentrations of the test item, dissolved in deionised water (ranging from 5014 to 50 µg/plate) were used.
concentrations tested: 5014/1504/501/150/50 µg/plate
Second Experiment:
To verify the results of the first experiment, a second experiment was performed, using five concentrations of the test item (ranging from 4999 to 312.5 µg/plate) and a modification in study performance (pre-incubation method).
Concentrations tested: 4999/2500/1250/625/312.5 µg/plate
Third Experiment:
To verify the results of the first experiment, a third experiment was performed, using five concentrations of the test item (ranging from 5004 to 312.5 µg/plate) and a modification in study performance (pre-incubation method).
Concentrations tested: 5004/2502/1251/625/312.5 µg/plate
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water and DMSO (historical data of the laboratory)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine (Strains 97a, 98, 102)
- Remarks:
- without metabolic activation system
- Untreated negative controls:
- yes
- Remarks:
- water and DMSO (historical data of the laboratory)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation system Migrated to IUCLID6: Strains 100 and 1535
- Untreated negative controls:
- yes
- Remarks:
- water and DMSO (historical data of the laboratory)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation system Migrated to IUCLID6: Strain 98
- Untreated negative controls:
- yes
- Remarks:
- water and DMSO (historical data of the laboratory)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (Strains 97a, 100, 102, 1535)
- Remarks:
- with metabolic activation system
Results and discussion
Test results
- Species / strain:
- other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Solubility and Toxicity (all three experiments):
No signs of toxicity towards the tested strains could be observed. The backround lawn was visible an the number of revertant colonies was not reduced.
Mutagenicity (all three experiments):
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item is not mutagenic in the Bacterial Reverse Mutation Test.
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