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EC number: 208-798-4 | CAS number: 542-08-5
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test item was not mutagenic in bacteria strains in the absence or presence of metabolic activation (reference 7.6.1 -1).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-10-22 to 1996-11-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983-05-26
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Version / remarks:
- September 1985
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The study was conducted according to OECD 471 from 1983. According to that guideline version only 4 strains were required.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : rat liver
- method of preparation of S9 mix: Sufficient S9 fraction was thawed immediately at room temperature before each test. One volume of S9 fraction (protein concentration 49.9 g/L for both experiments) was mixed with 9 volumes of the S9 cofactor solution, which was kept on ice until used. The concentrations of the different compounds in the S9-mix were: 8 mM MgCI2, 33 mM KCI, 5 mM glucose-6-phosphate, 4 mM NADP, 100 mM phosphate buffer pH 7.4
- volume of S9 mix used in agar: 0.5 mL
- quality controls of S9: Sterility test was done on plates and for each batch of S9 an independent validation was performed with a minimum of two different mutagens, e.g. 2-aminoanthracene and dimethylbenzanthracene, to confirm metabolic activation by microsomal enzymes, - Test concentrations with justification for top dose:
- 4, 20, 100, 500, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle used: DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene With metabolic activation for all strains
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
Precise toxicity testing was performed as follows using dose levels selected on the basis of toxicity results in the first test: 0.1 mL of the different concentrations of the test compound were thoroughly mixed with 0.1 mL of 10^6 dilution of the overnight culture of TA 100 (designated TA 100 D) and plated with histidine and biotin rich top agar (3 plates per dose). The solvent control was compared with the number of colonies per plate in the presence of the test compound. Results were determined as a ratio of these values (= surviving fraction). - Evaluation criteria:
- A test compound was classified as mutagenic if it had either of the following effects:
a) it produced at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawns.
b) it induced a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawns.
If the test substance did not produce reproducible increases of at least 2 times the concurrent solvent controls, at any dose level with any bacterial strain, it was considered to show no evidence of mutagenic activity in this system.
The test results had to be reproducible. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- The test item was not mutagenic in bacteria strains in the absence or presence of metabolic activation.
- Executive summary:
A bacterial reverse mutation assay according to OECD 471 was conducted to evaluate the mutagenic potential of the test item. Bacterial strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 were treated with 4, 20, 100, 500, 2500 and 5000 µg test item/plate in the absence and presence of metabolic activation with S9-mix in two independent experiments with triplicates for each strain. Furthermore, positive, solvent and untreated controls were conducted. The test item did not precipitate on the plates up to the highest investigated dose of 5000 µg/plate and proved to be not toxic to the bacterial strains. In an additional toxicity test with a dilution of tester strain TA 100 (designated TA 100 D), which was performed in parallel with the second mutation experiment, no toxicity was found. The test item did not cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or in the presence of S9-mix in either mutation test. No dose-dependent effect was obtained. All positive controls produced significant increases in the number of revertant colonies. Thus, the sensitivity of the assay and the efficacy of the exogenous metabolic activation system were demonstrated. Based on results obtained it was concluded that the test item was not mutagenic in bacteria strains in the absence or presence of metabolic activation.
Reference
Table 1: Experiment 1
Dose (µg/plate) | Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium | |||
TA98 | TA100 | TA1535 | TA1537 | |
Results without S9 | ||||
DMSO | 18.7 ± 3.2 | 137.0 ± 21.1 | 17.0 ± 2.6 | 12.0 ± 2.0 |
untreated | 20.3 ± 6.1 | 163.3 ± 2.5 | 19.7 ± 3.1 | 10.7 ± 1.2 |
4 | 21.7 ± 6.4 | 128.3 ± 9.7 | 19.3 ± 2.5 | 14.7 ± 4.5 |
20 | 17.7 ± 0.6 | 109.3 ± 20.8 | 18.0 ± 3.0 | 10.3 ± 4.5 |
100 | 17.0 ± 1.7 | 117.7 ± 12.9 | 20.0 ± 4.0 | 14.0 ± 5.2 |
500 | 19.7 ± 0.6 | 124.0 ± 34.9 | 19.7 ± 2.9 | 11.3 ± 2.1 |
2500 | 18.0 ± 2.6 | 103.7 ± 17.9 | 19.3 ± 2.1 | 10.3 ± 4.2 |
5000 | 18.7 ± 2.1 | 62.7 ± 21.5 | 17.0 ± 1.0 | 11.7 ± 1.5 |
2-NF | 567.3 ± 95.1 | |||
SA (1) | 782.7 ± 21.0 | 397.7 ± 24.4 | ||
9-AA (50) | 169.7 ± 18.6 | |||
Results with S9 | ||||
DMSO | 22.7 ± 3.1 | 162.7 ± 13.1 | 20.3 ± 2.5 | 11.0 ± 3.6 |
untreated | 22.7 ± 1.5 | 146.3 ± 21.7 | 13.7 ± 1.5 | 15.7 ± 2.1 |
4 | 26.3 ± 8.4 | 137.0 ± 2.6 | 19.0 ± 4.6 | 11.0 ± 1.0 |
20 | 25.0 ± 4.6 | 141.0 ± 14.1 | 21.0 ± 2.0 | 11.7 ± 3.8 |
100 | 20.7 ± 3.8 | 137.0 ± 11.5 | 20.7 ± 1.4 | 11.0 ± 5.0 |
500 | 19.7 ± 3.2 | 122.7 ± 16.7 | 22.7 ± 1.5 | 9.0 ± 3.0 |
2500 | 22.7 ± 1.2 | 132.3 ± 10.3 | 19.7 ± 4.0 | 10.7 ± 2.1 |
5000 | 18.0 ± 1.0 | 116.7 ± 30.6 | 22.0 ± 1.0 | 10.3 ± 3.5 |
2-AA (0.5) | 1870.0 ± 71.6 | 1971.0 ± 128.7 | ||
2-AA (1) | 194.0 ± 14.7 | 331.0 ± 48.0 |
Table 2: Experiment 2
Dose (µg/plate) | Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium | |||
TA98 | TA100 | TA1535 | TA1537 | |
Results without S9 | ||||
DMSO | 24.0 ± 6.9 | 180.3 ± 12.3 | 25.0 ± 5.3 | 9.0 ± 1.7 |
untreated | 33.3 ± 6.0 | 174.0 ± 9.5 | 23.0 ± 4.6 | 9.3 ± 2.5 |
4 | 29.0 ± 1.0 | 153.3 ± 9.7 | 17.7 ± 2.9 | 8.0 ± 2.0 |
20 | 29.0 ± 0.0 | 176.3 ± 30.0 | 20.0 ± 3.5 | 7.3 ± 2.3 |
100 | 25.7 ± 3.2 | 153.0 ± 22.1 | 18.0 ± 6.1 | 8.3 ± 2.1 |
500 | 30.0 ± 7.5 | 144.7 ± 15.4 | 22.0 ± 1.7 | 8.7 ± 0.6 |
2500 | 28.0 ± 5.0 | 113.7 ± 8.7 | 15.3 ± 2.5 | 7.3 ± 0.6 |
5000 | 32.3 ± 1.5 | 113.3 ± 16.2 | 20.0 ± 6.2 | 9.0 ± 1.7 |
2-NF | 514.3 ± 49.9 | |||
SA (1) | 659.0 ± 26.2 | 365.7 ± 21.0 | ||
9-AA (50) | 182.7 ± 33.7 | |||
Results with S9 | ||||
DMSO | 23.3 ± 4.5 | 170.3 ± 29.2 | 24.7 ± 2.5 | 9.3 ± 0.6 |
untreated | 40.3 ± 4.9 | 194.7 ± 13.2 | 22.0 ± 1.0 | 9.3 ± 1.5 |
4 | 29.0 ± 1.7 | 181.0 ± 9.5 | 22.7 ± 1.2 | 9.3 ± 0.6 |
20 | 29.7 ± 4.5 | 172.7 ± 22.5 | 26.0 ± 8.2 | 8.7 ± 0.6 |
100 | 31.3 ± 3.2 | 189.3 ± 13.2 | 23.7 ± 6.4 | 11.3 ± 5.1 |
500 | 36.0 ± 3.5 | 178.3 ± 11.5 | 26.0 ± 6.2 | 10.3 ± 3.1 |
2500 | 27.3 ± 2.5 | 161.3 ± 7.8 | 19.7 ± 2.9 | 7.3 ± 1.2 |
5000 | 27.3 ± 2.5 | 168.3 ± 12.9 | 16.3 ± 2.5 | 9.0 ± 1.7 |
2-AA (0.5) | 2125.7 ± 75.0 | 2158.7 ± 26.3 | ||
2-AA (1) | 194.3 ± 28.7 | 473.3 ± 10.2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic toxicity in vitro
A bacterial reverse mutation assay according to OECD 471 was conducted to evaluate the mutagenic potential of the test item. Bacterial strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 were treated with 4, 20, 100, 500, 2500 and 5000 µg test item/plate in the absence and presence of metabolic activation with S9-mix in two independent experiments with triplicates for each strain. Furthermore, positive, solvent and untreated controls were conducted. The test item did not precipitate on the plates up to the highest investigated dose of 5000 µg/plate and proved to be not toxic to the bacterial strains. In an additional toxicity test with a dilution of tester strain TA 100 (designated TA 100 D), which was performed in parallel with the second mutation experiment, no toxicity was found. The test item did not cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or in the presence of S9-mix in either mutation test. No dose-dependent effect was obtained. All positive controls produced significant increases in the number of revertant colonies. Thus, the sensitivity of the assay and the efficacy of the exogenous metabolic activation system were demonstrated. Based on results obtained it was concluded that the test item was not mutagenic in bacteria strains in the absence or presence of metabolic activation.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on genetic toxicity, the test item does not require
classification for genetic toxicity according to Regulation (EC) No
1272/2008 (CLP), as
amended for the fifteenth time in Regulation (EU) 2020/1182.
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