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EC number: 281-866-9 | CAS number: 84045-65-8
- 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:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only four tester strains tested; no tester strain to detect cross-linking mutagens was included.
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate
- Cas Number:
- 84045-65-8
- Molecular formula:
- C31H21Na3ClN7O10S3
- IUPAC Name:
- Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- None
Method
- Target gene:
- Histidine-auxotrophic strains of Salmonella typhimurium
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction from rats
- Test concentrations with justification for top dose:
- 0.2, 2, 20, 200 and 2000 µg (or nl) per Petri dish
- Vehicle / solvent:
- distilled-water
Controls
- Untreated negative controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: TA 98 daunomycine (1 µg); TA 100 and TA 1535: MNNG (1.6 µg); and TA 1537: 9-aminoacridine (50 µg). With S9: all strains 2-anthramine.
- Details on test system and experimental conditions:
- GROWING AND CONSERVATION OF BACTERIAL TEST STRAINS
The bacterial strains were kept as frozen broth cultures, in aliquots of 0.5 ml at -70 °C with 8.0 % dimethylsulfoxide (DMSO). Fresh cultures were prepared by adding 0.1 ml of a thawed stock culture to 15 ml of nutrient broth (normal Difco nutrient broth for strains TA 1535 and TA 100, and double strength Difco nutrient broth for TA 1537 and TA 98, in 0.5 % NaCI). A nutrient agar (2.5 % Difco nutrient broth, 1.2% Difco agar) was also streaked. The broth was incubated in the dark in a shaking water bath at 37 °C for 16 hours, while the plate was incubated at 37 °C overnight. Broths and plates were then transferred
to the refrigerator, for up to one week.
PREPARATION OF MATERIALS
The minimal-glucose agar medium base was prepared from a 1.5 % Bacto-Difco agar in Vogel & Bonner E medium with 2 % glucose. The top agar is a 0.6 % Bacto-Difco agar, 0.6 % NaCI solution. Before use, the agar was melted in a boiling water bath and then left to equilibrate to 45 °C. Ten ml of sterile 0.5 mM L-histidine - 0.5 mM biotin were added per 100 ml of top agar.
The compounds to be tested were prepared fresh daily in DMSO or in sterile water. The appropriate dilutions were made from a 20 mg (or nl)/ml stock. The S-9 mix was prepared fresh daily from sterile stocks. 0.5 ml contains:
4.0 µ moles MgCl2
16.5 µ moles KCl
2.5 µ moles G-6-P
2.0 µ moles NADP
50.0 µ moles Phosphate Buffer, pH 7.4
150.0 µl liver homogenate. - Evaluation criteria:
- The criteria of mutagenicity used in this test are a doubling of the spontaneous reversion rate and a dose-effect relationship.
Results and discussion
Test results
- Key result
- Species / strain:
- other: Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
RESULTS
The lack of evidence for mutagenicity existed both in the absence and presence of a liver microsomal enzyme preparation (S-9 mix) from male rats pretreated with Aroclor 1254 and over a concentration range of 0.2 to 2000 µg of product per Petri dish.Applicant's summary and conclusion
- Conclusions:
- FAT 40147/D is considered to be non-mutagenic in the bacterial reverse mutation assay.
- Executive summary:
A study was performed to investigate the potential of FAT 40147/D to induce gene mutations according to the bacterial reverse mutation assay using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100. The test article was tested at the following concentrations: 0.2, 2, 20, 200 and 2000 µg (or nl) per Petri dish. The lack of evidence for mutagenicity existed both in the absence and presence of a liver microsomal enzyme preparation (S-9 mix) from male rats pretreated with Aroclor 1254 and over a concentration range of 0.2 to 2000 µg of product per Petri dish. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce gene mutations. Therefore, FAT 40147/D is considered to be non-mutagenic in this bacterial reverse mutation assay.
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