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EC number: 917-830-2 | CAS number: 1186514-91-9
- 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
Not mutagenic or genotoxic
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:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 97
- Details on mammalian cell type (if applicable):
- S. typhimurium TA 97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from liver of rats treated with Arochlor 1254
- Test concentrations with justification for top dose:
- 5000 μg/plate, 1500 μg/plate, 500 μg/plate, 150 μg/plate and 50 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene Diamine 2-Amino-Anthracene, 2-Aminoanthracene
- Details on test system and experimental conditions:
- Two valid experiments were undertaken, first using the plate incorporation method and then using the preincubation method, according to guideline procedures.
- Evaluation criteria:
- The substance was considered to have mutagenic potential if a reproducible increase in the number of revertant colonies on the place exceeded an increase factor of 2 in at least one strain. A concentration-related increase over the range tested is also taken as sign of mutagenic activity.
- Key result
- Species / strain:
- S. typhimurium TA 97
- 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:
- 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:
- 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:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- 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:
- not applicable
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
- Conclusions:
- Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the present study
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell transformation assay
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 5 μL/mL, 0.63 μL/mL, 0.31 μL/mL, 0.16 μL/mL, 0.08 μL/mL and 0.04 μL/mL
A pre-test was performed with the sample substance to determine the concentrations needed for the experiment. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- Stocks of cells were checked for mycoplasma contamination and stored in liquid nitrogen in the cell bank of LAUS GmbH to allow a continuous stock of cells.
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- In an OECD 473 guideline study, the test item did not induce mutations in the HPRT locus of V79 cells in the absence and presence of metabolic activation. The substance is not considered mutagenic under the conditions of this study.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell micronucleus test
- Species / strain / cell type:
- lymphocytes:
- Remarks:
- primary cultures of human peripheral lymphocytes from nonsmoking volunteers ages 23-35
- Cytokinesis block (if used):
- Cytochalasin B, 6 µg/ml final concentration.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from livers of male rats treated with Arochlor 1254
- Test concentrations with justification for top dose:
- Pre Experiment- 5, 2.5, 1.25, 0.63, 0.31 μL/mL
Experiment 1 With metabolic activation - 0.5, 0.4, 0.3, 0.2, 0.1 μL/mL
Experiment 1 Without metabolic activation- 0.8, 0.6, 0.4, 0.2, 0.1 μL/mL
Experiment 2 Without metabolic activation- 0.6, 0.55, 0.5, 0.4, 0.2, 0.1 μL/mL
When the test item is a substance of unknown or variable composition, a complex reaction product or of biological origin (UVCB), testing may be started at a higher concentration to increase the amount of each of the test item components. - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- other:
- Details on test system and experimental conditions:
- Data are expressed as CBPI, or Cytokinesis Block Proliferation Index and calculated as the sume of mononucleated*1, binucleated*2 and multinucleated*3 cells divided by the total number of cells. Cytotoxicity was calculated as reduction in CBPI compared to the CBPI of the concurrent solvent control. The number of binucleated cells with and without micronuclei in each treatment group was compared with the solvent control value.
- Rationale for test conditions:
- According to OECD TG 487, the maximum concentration of the test item should be 2 µl/mL, 2 mg/mL or 10 mM, whichever is the lowest. When cytotoxicity occurs, the highest concentration should aim to produce 55 ± 5% cytotoxicity. When the test item is a UVCB, testing may be started at a higher concentration to increase the amount of each of the test item components. When solubility is a limiting factor, the maximum concentration, if not limited by cytotoxicity, should be the lowest concentration at which turbidity or minimal precipitate is visible in the cultures. For insoluble or particulate materials specific adaptation may be needed. For the test item ZEF 6099/100 (UVCB), the maximum concentration according to these demands was 5 µL/mL.
- Evaluation criteria:
- The test item is considered to have genotoxic effects if:
• At least one test concentration shows a statistically significant increase of micronucleated cells compared to the concurrent solvent control.
• In at least one experimental condition a dose-related increase of micronucleated cells can be observed.
• Any of the results lies outside the range of the historical laboratory control data for solvent controls - Statistics:
- The number of binucleated cells with micronuclei in each treatment group was compared with the solvent control. Statistical significance was tested using Fisher’s exact test at the five per cent level (p ≤ 0.05)
- Key result
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- There was no increase in the number of micronucelated cells after exposure to the test substance.
- Remarks on result:
- other: not genotoxic
- Conclusions:
- The test substance did not induce the formation of micronuclei in primary human lymphocytes in vitro, with and without metabolic activation.. It is considered not genotoxic under the conditions of the OECD 487 assay.
Referenceopen allclose all
ZEF 6099/100 showed no precipitates on the plates at any of the concentrations in either assay. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item ZEF 6099/100 showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation.
The proper concentration ranges were difficult to ascertain due to inconsistent cytotoxicity.
In the pre-experiment, cytotoxicity was observed at rates of 14.3 -25.1 at the two highest concentrations (2.5 and 5 microliter/ml), but complete toxicity was observed in the mid-dose of 1.25 microliter/ml. Lower concentrations resulted in cytotoxicity between 21.9 and 24.3%.
This can possibly be attributed to the fact that the test item in high concentration (neat and the first dilution) did not dissolve well in the test medium and as a consequence did not interact homogeneously with the cultivated lymphocytes in the aqueous cell culture medium. Therefore, in the first and the second main experiment (experiment I without and with metabolic activation, experiment II without metabolic activation – extended exposure) a different range of concentrations was tested.
In the experimental part of the study without metabolic activation, the 3 highest test item concentrations suggested mild precipitation (turbidity) and these were evaluated for genotoxicity. In the experimental part with metabolic activation, the highest tested concentration (0.8 µL/mL) revealed complete cytotoxicity. Therefore, the following three concentrations were scored for the presence of micronuclei. A cytotoxicity of 55±5% was not achieved, in spite of a narrow spacing of the concentrations. As no relation between test item concentration and proportion of binucleated cells was observed, this fact is considered noncritical.
No increase of the number of binucleated cells with micronuclei was detected at the evaluated concentrations and a second experiment (experiment II without metabolic activation, extended exposure) was performed.
In the second experiment, concentrations were: 0.6 microliters/ml, 0.55, 0.5, 0.4, 0.2 and 0.1 microliters/ml. Four concentrations were chosen for evaluation based on whether sufficient binucleated cells were available. At the two highest evaluated concentrations of the test item, the proportion of binucleated cells was higher than in the concurrent solvent control, but not statistically significant increased. The values obtained for these test item concentrations (0.5 and 0.6 µL/mL) lay above the historical laboratory control data for the solvent DMSO but still inside the 99.7% control range. No increase of the number of binucleated cells with micronuclei was detected at the concentrations of 0.2 and 0.1 µL/mL.
In conclusion, it can be stated that under the experimental conditions reported, the test item ZEF 6099/100 did not show genotoxic activity in this in vitro test for the induction of micronuclei.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The genotoxicity of the substance was investigated in several in vitro assays, including the bacterial Ames Assay, mammalian micronucleus in human peripheral lymphocytes, and mammalian mutagenicity (HPRT locus). All tests were negative for genetic toxicity.
Justification for classification or non-classification
The substance is not mutagenic or clastogenic, and hence, the criteria for genetic toxicity in Regulation EC No. 1272/2008 are not met. The substance is not classified for mutagenicity, and fails to qualify for mutagenicity in a CMR evaluation
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