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EC number: 252-525-1 | CAS number: 35355-77-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 15880:2.
- 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 itself showed no mutagenic effects in three salmonella strains with and without microsomal activation, in an Ames test comparable to OECD TG 471, non-GLP (1985).
An Ames test with five bacterial strains, including Prival modification was not performed for the test item. Reliable experimental data from two analogue substances are available. These substances were not considered to be mutagenic in S. typhimurium TA 1535, TA 100, TA 1537, TA 98 and E.coli WP2 uvrA in the absence or presence of a metabolic activation system (according to OECD TG 471 and GLP).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please, see the attached justification.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 10 - 21 january 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Only 3 strains tested, non-GLP study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- 3 strains had been tested instead of 5
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- other: S. typhimurium TA 98, TA 100 and TA 1537
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S-9 fraction
- Test concentrations with justification for top dose:
- The test substance was tested in concentrations of 20, 78, 313, 1250 and 5000 µg/ 0.1 mL with and wihout S9-mix
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (all strains)
- Remarks:
- With microsomal activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: daunorubicin-HC1 (TA 98), 4-nitroquinoline-N-oxide (TA 100), 9(5)aminoacridine-hydrochloride (TA 1537)
- Remarks:
- Without microsomal activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: The plates were incubated for about 48 hours at 37 ± 1.5 °C in darkness
NUMBER OF REPLICATIONS: Three Petri dishes were prepared per strain and per group.
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The test substance is generally considered to be nonmutagenic if the colony count in relation to the negative control is not doubled at any concentration.
- Statistics:
- When the colonies had been counted, the arithmetic mean was calculated.
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reduction in the colony count at the highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At the concentrations of 1250 and 5000 µg/ 0.1 mL the substance precipitated in soft agar.
RANGE-FINDING STUDIES: A preliminary toxicity test was carried out with the concentrations ranging from 0.08 to 5000 µg/0.1 mL.
COMPARISON WITH HISTORICAL CONTROL DATA: The spontaneous reversion in the control was within the historical control range for each strain.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Owing to a growth-inhibition effect of the substance on strain TA 100 a reduction in the colony count was observed at the highest concentration. - Conclusions:
- Under the conditions of this study, no mutagenicity was observed in the screening test with 3 strains of S. typhimurium.
- Executive summary:
In a reverse gene mutation assay in bacteria, three strains of S. typhimurium (TA 98, TA 100 and TA 1537) were exposed to five concentrations of the test item in the presence and absence of mammalian metabolic activation. The test substance was dissolved in DMSO and the test was performed with the following concentrations of the trial substance with and without microsomal activation: 20, 78, 313, 1250 and 5000 µg/0.1 mL. DMSO was used for the negative controls and a positve control was tested for each strain. No evidence of the induction of point mutations by the test item or by the metabolites of the substance formed as a result of microsomal activation was detectable in the strains of S. typhimurium used in these experiments. The spontaneous reversion in the control was within the historical control range for each strain and the positive controls induced the appropriate responses in the corresponding strains. Therefore, the test results are considered valid.
Referenceopen allclose all
Table 1: Results of a salmonella mutagenicity test with three strains
Without microsomal activation Number of back-mutant colonies per plate (arithmetic mean) | |||
Strain | TA 98 | TA 100 | TA 1537 |
Control | 20 | 136 | 5 |
25 µg/ 0.1 mL | 18 | 138 | 6 |
75 µg/ 0.1 mL | 24 | 133 | 7 |
225 µg/ 0.1 mL | 25 | 140 | 8 |
675 µg/ 0.1 mL | 21 | 106 | 6 |
2025 µg/ 0.1 mL | 15 | 57 | 6 |
Positive controls | |||
Daunorubicin-HC1 (10 µg/ 0.1 mL) | 843 |
|
|
4-nitroquinoline-N-oxide(0.25 µg/ 0.1 mL) |
| 1388 |
|
9(5)aminoacridine-hydrochloride(100 µg/ 0.1 mL) |
|
| 971 |
| |||
With microsomal activation Number of back-mutant colonies per plate (aritmethic mean) | |||
Strain | TA 98 | TA 100 | TA 1537 |
Control | 29 | 114 | 9 |
20 µg/ 0.1 mL | 35 | 126 | 12 |
78 µg/ 0.1 mL | 29 | 123 | 11 |
313 µg/ 0.1 mL | 28 | 134 | 10 |
1250 µg/ 0.1 mL | 35 | 159 | 12 |
5000 µg/ 0.1 mL | 30 | 97 | 7 |
Positive control of the microsomal activation | |||
2-amincanthracene (250 µg/ 0.1 mL) | 1000 | 770 | 84 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The genotoxic potential of the test substance itself was assessed in a reverse gene mutation assay. The conducted study satisfies OECD TG 471 (Bacterial Reverse Mutation Assay) with one deviation: 3 bacteria strains had been tested instead of 5 (S. typhimurium TA 98, TA100 and TA 1537). The test substance was dissolved in DMSO and the test was performed with the following concentrations of the trial substance with and without microsomal activation: 20, 78, 313, 1250 and 5000 µg/0.1 mL. DMSO was used for the negative controls and a positve control was tested for each strain. No evidence of the induction of point mutations by the test item or by the metabolites of the substance formed as a result of microsomal activation was detectable in the strains of S. typhimurium used in these experiments.The spontaneous reversion in the control was within the historical control range for each strain and the positive controls induce the appropriate responses in the corresponding strains.Therefore, the test results are considered valid.
An Ames test with 5 bacterial strains, including Prival modification was not performed with the test substance, but reliable experimental data for an analogue approach are available. Please, see the attached read-across justification in section 7.6.1 or 13.
CAS 6417-83-0:
The analogue substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. S. typhimurium (TA 1535, TA 100, TA 1537, TA 98) and E.coli (WP2 uvrA), in a reverse mutation assay (Ames standard plate test and Prival preincubation test) at concentrations of 33 μg - 5400 μg/plate with and without metabolic activation. Precipitation of the test substance was found depending on the test conditions from about 100 μg/plate onward. A weak bacteriotoxic effect was occasionally observed depending on the strain and test conditions from about 2700 μg/plate onward. A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the prival preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
CAS 7023-61-2:
The mutagenicity of the test substance was assessed in an in vitro reverse mutation assay (Ames standard plate test and Prival preincubation test) following OECD TG 471 and the principles of GLP. The test substance was administered to five bacterial strains (S. typhimurium TA 1535, TA 100, TA 1537, TA 98 and E.coli WP2 uvrA pKM 101) at concentrations of 3; 10; 33; 100; 333; 1000; 2500 and 5000 µg/plate with and without metabolic activation. Precipitation of the test item was observed from 333 µg/plate onwards in the test tubes and on the agar plates at different concentrations in both experiments. The undissolved particles had no influence on the data recording. The plates incubated with the test item showed normal background growth up to 5000 microgramms per plate with and without metabolic activation in both experiments. Minor toxic effects, were observed in some strains at concentrations of 2500 microgramms per plate or higher. No biologically relevant increase in the number of his+ or trp+ revertants was observed in the standard plate test or in the prival preincubation test neither without nor with a metabolizing system.
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 1272/2008. No indication of genotoxicity was observed in the Ames test (OECD 471, GLP). As a result, the substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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