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Diss Factsheets
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EC number: 472-690-5 | 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
In the Ames test, all bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments. The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Based on the results of the study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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:
- 22 September - 2 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 8 June 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : rat liver microsomal enzymes were routinely prepared from adult male Wistar rats (Charles River, Sulzfeld, Germany)
- concentration or volume of S9 mix and S9 in the final culture medium : 5% or 10% (v/v)
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): all S9 batches were characterized with the metabolic activation requiring positive control benzo[a]pyrene in TA98 at 5 ug/plate. - Test concentrations with justification for top dose:
- Dose range finding test with all strains: 3-10-33-100-333-1000-3330-5000 ug/plate in the absence and presence of S9.
Precipiation was observed in the dose range finder at 1000 ug/plate and above, toxicity in the absence of S9 at 100 ug/plate and above (TA100) or 333 ug/plate and above (WP2uvrA), toxicity in the presence of S9 at 1000 ug/plate and above (TA100 and WP2uvrA).
Mutation test 1 with TA98, TA1535, TA1537: 0.3-1-3-10-33-100-333 ug/plate in the absence of S9; 3-10-33-100-333-1000 ug/plate in the presence of S9.
Mutation test 2 with TA98, TA100, TA1535, TA1537: 0.3-1-3-10-33-100 ug/plate in the absence of S9; 3-10-33-100-333-1000 ug/plate in the presence of S9.
Mutation test 2 with WP2uvrA: 1-3-10-33-100-333 ug/plate in the absence of S9; 3-10-33-100-333-1000 ug/plate in the presence of S9. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO. Test substance concentrations were used within 4 hours after preparation.
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- All concentrations were tested in triplicate.
- Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) the total number of revertants in TA100 is not greater than 2 times the concurrent control, and the total number of revertants in the other tester strains is not greater than 3 times the concurrent control.
b) the negative response should be reproducible in at least one independently repeated experiment. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- precipitation @ 1000 ug
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- @100 and 333 ug without S9, @1000 ug with S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- precipitation @ 1000 ug
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- @100 and 333 ug without S9, @1000 ug with S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- precipitation @ 1000 ug
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- @100 ug without S9, @1000 ug with S9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- precipitation @ 1000 ug
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- @100 and 333 ug without S9, @1000 ug with S9
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- precipitation @ 1000 ug
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- @ 100 and 333 ug without S9
- Conclusions:
- All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments. The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Based on the results of the study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
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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