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EC number: 916-807-4 | 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
The test substance is not mutagenic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no Salmonella Typhimurium strain TA102 or E. Coli strain was used
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Description: Colourless liquid
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver
- Test concentrations with justification for top dose:
- 0, 3.09, 9.26, 27.78, 83.33, 250.00 µg/plate. Highest dose based on results preliminary test.
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 3 days
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: reduction of background lawn - Evaluation criteria:
- A positive response in the assay system is taken to be a two-fold or greater increase in the mean number of revertant colonies appearing in the test plates over and above the background spontaneous reversion rate observed with the vehicle, together with evidence of a dose response.
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
A preliminary test was carried out to assess the toxicity of the test substance for TA 98. Dose levels tested were 0, 3.78, 37.8, 378, 3780, and 37800 µg/plate. The results show that the test substance was toxic for the bacteria at dose levels of 378 µg/plate and higher, while no toxicity was observed at dose levels of 37.8 µg/plate and lower. At the highest dose levels used, the test substance precipitated in the plate.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
At the two highest dose levels, the test substance was toxic for TA 1537, TA 1538, TA 98, and TA 100, both in the absence and in the presence of the S9-mix, as evidenced by a diminished growth of the bacterial background lawn. With TA 1535 slight toxicity was observed at the highest dose level used, only in the absence of the S9-mix.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the first bacterial reverse mutation assay, performed according to OECD Guideline 471 and following GLP, Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100 and Escherichia coli strain WP2uvrA were exposed to the test material in DMSO (vehicle) with a pre-incubation method in the presence and absence of a metabolic activation system (S9 mix). Test concentrations used were without metabolic activation (µg/plate): 0, 0.610, 1.22, 2.44, 4.88, 9.77, 19.5, 39.1 (E. Coli only), 78.1 (E. Coli only) and with metabolic activation (µg/plate): 0, 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156, (E. Coli only) 313 (E. Coli only). These concentrations are based on the results of a preliminary test. The results of the vehicle and positive controls show the validity of the test. It was concluded that the test substance did not increase the number of revertants in the presence and absence of S9 -mix.
In the second bacterial reverse mutation assay, performed similar to OECD Guideline 471 and following GLP, Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100 were exposed to the test material in DMSO (vehicle) using the pre-incubation method. Test concentrations used were 0, 3.09, 9.26, 27.78, 83.33, and 250 µg/plate. These concentrations are based on the results of a preliminary test with Salmonella typhimurium strain TA 98. Strains were exposed in the presence and absence of a metabolic activation system (S9). The results of the vehicle and positive controls show the validity of the test. It was concluded that the test substance did not increase the number of revertants in the presence and absence of S9 -mix.
Justification for classification or non-classification
The test substance does not have to be classified for mutagenicity according to Regulation (EC) No 1272/2008.
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