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EC number: 436-000-6 | CAS number: 159010-67-0
- 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:
- weight of evidence
- Study period:
- From February 14th to 16th, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Blue REg 6080
- IUPAC Name:
- Blue REg 6080
Constituent 1
Method
Species / strain
- 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:
- S9 liver fractions of rats, induced with phenobarbital/ beta-naphthoflavone
- Test concentrations with justification for top dose:
- Concentration range in the main test (with and without metabolic activation): 33, 100, 333, 1000, 2500, 5000 µg/plate
- Vehicle / solvent:
- DMSO, chosen because of solubility and nontoxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation in the overlay agar: 1000 µg/plate and above.
Each concentration, including the controls, was tested in triplicate in a plate incorporation test. - Rationale for test conditions:
- A pre-experiment on toxicity was run on TA98 and TA100.
The plates incubated with the test item showed normal background growth up to 5000 μg/plate with and without metabolic activation in both independent experiments. - Evaluation criteria:
- A test item is considered mutagenic if in strains TA98, TA100, TA102 the numebr of reversions is at least twice as high and in strains TA1535, TA1537 at least three times higher as comparede to the spontaneous reversion rate.
Also a dose dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of test item regardeless whether the highest dose induced the above described enhancement factors or not.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA1537, TA98, TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1535, TA102
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Substantial and dose dependent increases in revertant colony numbers were observed following treatment with test item in strains TA 1537, TA 98, and TA 100 in the presence and absence of metabolic activation (S9 mix) and in strains TA 1535 and TA 102 in the presence of metabolic activaiton. The number of colonies exceeded the threshold of twice (strains TA 98, TA 100, and TA 102) and thrice (strains TA 1535 and TA 1537) the number of the corresponding solvent control. In the presence of metabolic activation, the number of revertant colonies was reduced at higher concentrations. This effect may either be based upon slight toxic effects of the test item or upon the heavy precipitation of the test item interfering with bacterial colony growth.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- During the described mutagenicity test and under the experimental conditions reported, the test item induced gene mutations by base pair changes and frameshifts in the genome of the strains TA 1535, TA 1537, TA 98, TA 100, and TA 102.
Therefore, test item is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
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