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EC number: 931-341-1 | CAS number: 68955-55-5
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1989-01-31 to 1989-02-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 308062-28-4
- EC Number:
- 608-528-9
- Cas Number:
- 308062-28-4
- IUPAC Name:
- 308062-28-4
- Details on test material:
- - Name of test material (as cited in study report): Genaminox LA
- Composition of test material, percentage of components: 30% lauryldimethylaminoxide; 70% water
- Lot/batch No.: 88/1307
-pH value in water: 6-8
- Storage condition of test material: Dark at 22 degrees Centigrade
Constituent 1
Method
- Target gene:
- Histidine for Salmonella typhimurium
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 100, TA 1535, TA 1537, TA 1538 and TA 98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: All five strains are deficient in complete structure of their lipopolysaccharide layer and in DNA excision repair system
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 rat liver induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Zero to 10,000 microgram/plate (see Tables 1-10, attached)
- Vehicle / solvent:
- Compound was dissolved in 100 uL DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With S9 mix
Migrated to IUCLID6: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene with TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: TA 100 and TA 1535
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: TA 1537
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: TA 98 and TA 1538
- Details on test system and experimental conditions:
- Preparation and storage of liver homogenate fraction (S-9)
Male Sprague Dawley rats (200-300 g) received a single intraperitoneal injection of Aroclor 1254 (500 mg/kg bodyweight) 5 days before sacrifice. Preparation was performed at 0 to 4 degrees Centigrade using cold sterile solution and glassware. The livers from at least 5-6 animals were removed and pooled before washing in 150 mM KCl (approximately 1 mL/g wet livers). The washed livers were cut into small pieces and homogenized in three volumes of KCl. The homogenate was then centrifuged at 9000 g for 10 minutes. The supernatent (the S-9 fraction) was divided into small portions, frozen rapidly and stored at -80 degrees Centigrade for not longer than three months.
Preparation of S-9 Mix
Sufficient S-9 fraction was thawed immediately before each test at room temperature. One volume of S-9 fraction was mixed with 9 volumes of the S-9 cofactor solution and kept on ice until required. That preparation was termed the S-9 mix and the composition was defined as follows: 8mM magnesium chloride; 33 mM potassium chloride; 5 mM glucose-6-phosphate; 4 mM NADP+; 100 mM phosphate buffer pH 7.4.
Bacteria
Bacteria were grown overnight in nutrient broth (25 g Oxoid Nutrient Broth No 2/L) at 37 degrees Centigrade. A presence of a suitable amount of bacteria in the cell suspension was checked by nephelometry. For inoculation, stock cultures stored at -80 degrees Centigrade were used and the various bacterial strains were periodically identified.
Toxicity experiments and dose range finding
The first experiment was performed with all tester strains using three plates per dose to obtain information on mutagenicity and toxicity for calculation of an appropriate dose range. A reduced rate of spontaneously occurring colonies was used as an indicator for toxicity together with visible thinning of the bacterial lawn. Thinning of the bacterial lawn was controlled microscopically.
In combination with the second experiment, toxicity testing was performed as follows: 0.1 mL of the relevant test compound dilution was thoroughly mixed with 0.1 mL of 10E-6 dilution the overnight culture of TA 100 and plated onto histidine and biotin rich top agar (3 plates per dose).
Mutagenicity test
Top agar was prepared for the Salmonella strains by mixing 100 mL agar (0.6% agar, 0.5 % sodium chloride) with 10 mL of a 0.5 mM histidine-biotin solution. The following ingredients were added (in order) to 2 mL of molten top agar at 45 degrees Centigrade: 0.1 mL of an overnight nutrient broth culture of the bacterial tester strain; 0.1 mL test compound solution; 0.5 mL S-9 mix (if required) or buffer. After mixing, the liquid was poured into a petridish with minimal agar (1.5 % agar, Vogel-Bonner E medium with 2 % glucose). - Evaluation criteria:
- The solvent control was compared with the number of colonies per plate in the presence of the test compound. Results were then presented as a ratio of these values (equal to surviving fraction). For the mutagenicity test, colonies (his+ revertants) were counted after incubation for 48 to 72 hours at 37 degrees Centigrade in the dark.
- Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: S. typhimurium TA 100, TA 1535, TA 1537, TA 1538 and TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA 100, TA 1535, TA 1537, TA 1538 and TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Referring to Tables 1-5 (attached), the test compound proved to be toxic to the bacterial strains at a dose of 2,500 microgram per plate with metabolic activation and very toxic to the bacterial strains at a dose of 20 microgram/plate without metabolic activation. For mutagenicity testing, 2,500 microgram/plate was chosen as the highest dose in the second experiment.
The test compound did not cause a significant increase in the number of revertant colonies with any of the tester strains either in the the absence or presence of S-9 mix. No dose dependent effect is shown by the results presented in Tables 6-10 (attached). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance is not mutagenic in the presence or absence of an exogenous metabolizing system
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