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EC number: 401-540-3 | CAS number: 84632-65-5
- 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

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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. GLP accordance not stated in the report. Test article precipitated in soft agar from the lowest concentration used in the Ames assay. No analytical monitoring of test concentration was done.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1981)
- Deviations:
- yes
- Remarks:
- no statistical analysis was performed
- GLP compliance:
- no
- Remarks:
- not stated in the report
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Purity: Commercial grade
- Lot/batch No.: Op. 11006
- Stability of test article: In the report it was stated that stability was guaranteed by the sponsor.
Constituent 1
Method
- Target gene:
- All strains are histidine auxotrophic mutants.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- One millilitre activation mixture contained 0.3 ml S9 fraction of liver from rats (Tif:RAIf(SPF)) induced with Aroclor 1254 and 0.7 ml of a solution of co-factors.
- Test concentrations with justification for top dose:
- A preliminary toxicity test was carried out with concentrations ranging from 0.08 to 5000 µg/plate suspended in dimethylsulfoxide.
Ames test (without and with microsomal activation): 20, 78, 313, 1250 and 5000 µg/plate suspended in dimethylsulfoxide. - Vehicle / solvent:
- - Vehicle used: dimethylsulfoxide (DMSO)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Without S9-Mix
- Positive control substance:
- other: Daunorubicin-HCl (5 and 10 µg/plate)
- Remarks:
- TA 98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Without S9-Mix
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- TA 100
Migrated to IUCLID6: 0.125 and 0.25 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Without S9-Mix
- Positive control substance:
- mitomycin C
- Remarks:
- TA 102
Migrated to IUCLID6: 0.5 and 1 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Without S9-Mix
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535
Migrated to IUCLID6: 2.5 and 5 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Without S9-Mix
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537
Migrated to IUCLID6: 50 and 100 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- With S9-Mix
- Positive control substance:
- other: 2-aminoanthracene 5 µg/plate
- Remarks:
- TA 98, TA 100, TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- With S9-Mix
- Positive control substance:
- other: 2-aminoanthracene 20 µg/plate
- Remarks:
- TA 102
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- With S9-Mix
- Positive control substance:
- cyclophosphamide
- Remarks:
- TA 1535
Migrated to IUCLID6: 250 µg/plate
- Details on test system and experimental conditions:
- The study consisted of a toxicity pre-screen test followed by the Ames assay (with and without S9-Mix).
OTHER EXAMINATIONS
A preliminary toxicity test was carried out with the concentrations ranging from 0.08 to 5000 µg/plate. Thereafter, the Ames test was performed with 20, 78, 313, 1250 and 5000 µg/plate test article (with and without microsomal activation). The substance precipitated in soft agar at and above a concentration of 20 µg/plate.
MUTATION TEST
Mutation assays with and without microsomal activation were performed twice in triplicate per strain and per group (standard plate test).
Each Petri dish contained approximately 20 ml of minimum agar, 0.1 ml of the test substance or the vehicle and 0.1 ml of a bacterial culture (in nutrient broth) in 2.0 ml of soft agar. Experiments with microsomal activation contained additionally 0.5 ml of an activation mixture, consistent of S9 fraction of liver from Aroclor 1254 induced rats and co-factors. The plates were incubated for about 48 hours at 37 ± 1.5°C in darkness.
EVALUATION CRITERIA
Arithmetic mean of revertant colonies was calculated. The test substance is considered to be non-mutagenic if the colony count in relation to the negative control is not doubled at any concentration. - Statistics:
- No statistical analysis
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Cytotoxicity was assessed in a pretest up to 5000 µg/plate. No further details are available.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Cytotoxicity was assessed in a pretest up to 5000 µg/plate. No further details are available.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The substance precipitated in soft agar at and above a concentration of 20 µg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The number of histidine-prototrophic mutants after treatment with the substance did not vary markedly in comparison to the negative control in any of the experiments.
Applicant's summary and conclusion
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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