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EC number: 289-530-3 | CAS number: 89899-25-2
- 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
An in vitro study was performed to investigate the potential of the test substance to induce gene mutations according to method equivalent to OECD Guideline 471.
The substance was tested for mutagenic effects with Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 without and with metabolic activation at doses from 0.2 to 2000 µg active ingredient/plate. The lack of evidence for mutagenicity existed both in the absence and presence of metabolic activation.
Under the experimental conditions followed in the protocol and employing a doubling of the spontaneous reversion rate and dose-effect relationship as criteria of mutagenicity, the product FAT 20290/A was not mutagenic for S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100. Therefore, FAT 20290/A was non-mutagenic in the Salmonella typhimurium reverse mutation assay.
Link to relevant study records
- 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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only 4 tester strains tested; no tester strain to detect cross-linking mutagens was included (TA 102 or E.coli WP2 uvra); maximum concentration tested 2000 mg/plate and not 5000 g/plate as recommended by the guideline as of today;
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine gene
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Mutagenicity tests: 0.2, 2, 20, 200 and 2000 µg (or nl) per Petri dish
- Vehicle / solvent:
- No data
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- other: 2-anthramine; N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), Daunomycine:
- Details on test system and experimental conditions:
- No data
- Evaluation criteria:
- The criteria of mutagenicity used in this test are a doubling of the spontaneous reversion rate and a dose-effect relationship.
- Statistics:
- No data.
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The substance FAT 20290/A was tested with the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at concentrations from 0.2 to 2000 M9 (or nl) per Petri dish both in the presence and absence of metabolic activation.
No mutagenic effect was observed. - Conclusions:
- FAT 20290/A was considered to be non-mutagenic in the Salmonella typhimurium reverse mutation assay.
- Executive summary:
An in vitro study was performed to investigate the potential of the test substance to induce gene mutations according to method equivalent to OECD Guideline 471.
The substance was tested for mutagenic effects with Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 without and with metabolic activation at doses from 0.2 to 2000 µg active ingredient/plate. The lack of evidence for mutagenicity existed both in the absence and presence of metabolic activation.
Under the experimental conditions followed in the protocol, and employing a doubling of the spontaneous reversion rate and dose-effect relationship as criteria of mutagenicity, the product FAT 20290/A was not mutagenic for S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100.
Therefore, FAT 20290/A was considered to be non-mutagenic in the Salmonella typhimurium 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
Based on the available genotoxicity study, the test substance does not need to be classified for genotoxicity according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 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.