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EC number: 233-915-0 | CAS number: 10433-41-7
- 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
Mutagenicity of the test substance was assessed in the bacterial reverse mutation test using five strains, Salmonella typhimurium TA100, TA1535, TA98, and TA1537 and Escherichia coli WP2 uvrA. The test was conducted up to 5000 µg/plate as the maximum dose using 8 doses with a common ratio of 4. According to the results, the number of revertant colonies treated with the lest substance was less than twice that treated with the negative control (solvent) in any tester strain with or without S9 mix. Moreover, microbial growth inhibition or precipitation of the test substance was not observed at any dose in all tester strains with and without S9 mix.
From these results described, it was concluded that the test substance was not mutagenic under the conditions employed in this study.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot number of test material: sponsor, 70404
- Purity: 96.8 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, shielded from light in airtight container. - 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: S9 mix
- Test concentrations with justification for top dose:
- 5000 µg/plate
- Vehicle / solvent:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-(2-Fury )-3-( 5-nitro-2-fury l) acrylamide (AF-2) and 2-Aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- According to the test guidelines, the preliminary test was performed at the following doses:
With and without S9 mix: 5000, 1250, 313, 78.1, 19.5, 4.88, 1.22, 0.305 µg/plate.
According to the results of the preliminary test, revertant colonies did not increase in any tester strains with or without S9 mix. Microbial growth inhibition was not observed in all strains. Based on these results, main tests I and II were performed at the following doses:
With and Without S9 mix: 5000, 2500, 1250, 625, 313 µg/plate
Pre-incubation method:
(1) For each treatment, 0.1 mL of the test substance solution, negative (solvent) control or 0.1 mL of positive control solution was added into a sterilized test tube with an aluminum top.
(2) For assays without S9 mix, 0.5 mL of 0.1 mol/L sodium phosphate buffer (pH 7.4) and 0.1 mL ofthe bacterial suspension were added to the test substance solutions.
(3) For assays with S9 mix, 0.5 mL of S9 mix was mixed in place of 0.1 mol/L sodium phosphate buffer.
(4) The mixture was incubated with gentle shaking (shaking frequency: 120 times/minute) at 37°C for 20 minutes (pre-incubation).
(5) After pre-incubation, 2 mL of the molten top agar was added to this mixture and then poured onto the minimal glucose agar plate.
(6) After the overlaid agar had solidified, the plates were incubated for 48 hours at 37°C.
Observation :
Precipitation: Precipitation was judged by observation of the plate surface macroscopically.
Microbial growth inhibition: Background lawn of the bacterial cells that have amino-acid requirement was observed by a stereoscopic microscope (40x; Nikon, SMZ-10), and microbial growth inhibition was judged by the relationship between the test substance treated plates and the non-treated plate.
Measurement of colony number.
Revertant colonies were measured using an automatic colony counter (Toyo Sokki Co. Ltd., CA-7) or manual counting. Revertant colonies in the positive control treatment groups and those in TAIOO ofthe test substance treatment groups were measured using an automatic colony counter and the others were measured by manual counting. Correction ofthe measuring area was employed using instrumental analysis.
Number of plate:
Preliminary test: 1 plate/dose; (negative and positive control treatment groups: 2 plates/dose)
Maintest I: 3 plates/dose
Maintest II: 3 plates/dose - Evaluation criteria:
- The main tests were accepted as valid if all the following criteria were satisfied. The preliminary test was accepted to obtain the data by which doses were set in the main test.
(1) The negative (solvent) control values (mean) and the positive control values (mean) are within the proper ranges calculated based on the historical data at the testing facility.
(2) The positive control values (mean) show clear positive responses in the respective tester strains, as evidenced by the number of revertant colonies being greater than 2-fold of the respective negative (solvent) control value.
(3) There are more than 4 doses showing no microbial growth inhibition and more than 5 doses applicable to the evaluation in the main test.
(4) The result of the sterility test indicates that there is no bacterial or fungous contamination.
(5) There are no plates that become invalid for measurement due to contamination or other unexpected situations. - Statistics:
- The mean and standard deviation of the revertant colonies were calculated for the negative (solvent) control, the positive control, and the test substance treatment groups. The mean and standard deviation were expressed by rounding to the first decimal place.
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- In the preliminary and two main tests, the number of revertant colonies induced by the test substance was less than twice the corresponding negative control value for all tester strains with and without S9 mix. Furthermore, all tests indicated that they were performed accurately as the tests satisfied acceptable the specified criteria.
From the results described above, it was concluded that the test substance was not mutagenic under the conditions employed in this study. - Executive summary:
Mutagenicity of the test substance was assessed in the bacterial reverse mutation test using five strains, Salmonella typhimurium TA100, TA1535, TA98, and TA1537 and Escherichia coli WP2 uvrA. The test was conducted by the pre-incubation method with and without S9 mix.
A preliminary test was performed at 5000 µg/plate as the maximum dose using 8 doses with a common ratio of 4. According to the results, the number of revertant colonies treated with the lest substance was less than twice that treated with the negative control (solvent) in any tester strain with or without S9 mix. Moreover, microbial growth inhibition or precipitation of the test substance was not observed at any dose in all tester strains with and without S9 mix.
Main test I was performed at 5000 µg/plate as the maximum dose using 5 doses with a common ratio of 2 based on the results of the preliminary test. According to the results, the number of revertant colonies treated with the test substance was less than twice that treated with the negative control in any tester strain with or without S9 mix. Moreover, microbial growth inhibition or precipitation of the test substance was not observed at any dose in all tester strains with and without S9 mix.
Main test II was performed using the same doses as main test I. According to the results, the number of revertant colonies treated with the test substance was less than twice that treated with the negative control in any tester strain with or without S9 mix. Moreover, microbial growth inhibition or precipitation of the test substance was not observed at any dose in all tester strains with and without S9 mix.From the results described above, it was concluded that the test substance was not mutagenic under the conditions employed in this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
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