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EC number: 684-879-1 | CAS number: 848641-69-0
- 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 registration substance showed negative results in the study for the induction of gene mutations (bacterial reverse mutation assay) by frameshift or base-pair substitutions with and without metabolic activation. The study was performed with the test strains S. typhimurium TA 98, TA 100, TA 97a, TA 102, and TA 1535. Test concentrations up to the limit concentration of 5 µL/plate were tested in the experiment. The test compound proved to be not mutagenic to the bacterial strains
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:
- May 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The Guidelines for the Testing of Chemicals-health effects (2nd edition): 471, 472 Bacterial Reverse Mutation Test (China environmental press)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Lot No.: 187-9-113-Y
Purity: >/=98%
light yellow liquid - Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- 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
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : from pretreated rat liver; purchased from Beijing Hongjie Technology Co. Ltd., China
- method of preparation of S9 mix: no data; purchase
- concentration or volume of S9 mix and S9 in the final culture medium : 8 mmol/L
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability):
histidine and biotin requirement test, ant-tetracycline test, ampicilin resistance test, crystal violet/UV sensitivity test, spontaneous back mutation test - Test concentrations with justification for top dose:
- Experiment I:
0.05, 0.158, 0.5, 1.58 and 5 µL/plate
Experiment II:
0.008, 0.04, 0.2, 1 and 5 µL/plate
According to the pre test there was no cytotoxicty up to 5 µL/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:
recommended by guideline
- Justification for percentage of solvent in the final culture medium:
recommended by guideline - Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: acridine orange, 2-aminofluorene, 1,8-dihydroxy-anthraquinone
- 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:
- Cell density at seeding (if applicable): 10 (e)8 / plate
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: n.a.
- Exposure duration/duration of treatment: 48 h
- Harvest time after the end of treatment (sampling/recovery times): n.a.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition - Rationale for test conditions:
- Conditions were chosen based on the guideline and results of the pre test.
- Evaluation criteria:
- The test substance is considered to be mutagenic, if
- a dose-related increase occurs in revertant count with or without metabolic activation in one or more strains or
- the number of revertant colonies in one or more dose groups shows a reproducible increase
The test substance is considered to be not mutagenic, if no increase in the revertant number is observed.
Significant positive results do not require further validation. Negative or inconclusive results require a change in the test conditions (changed to 5 times dose spacing) in the experimental repetition. - Statistics:
- not mandatory
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- TA 97a
- 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
- Positive controls validity:
- valid
- 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
- Positive controls validity:
- valid
- 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
- Positive controls validity:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- 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
- Positive controls validity:
- valid
- Conclusions:
- Based on the result of the present Ames Test the test substance is considered to be not mutagenic.
- Executive summary:
The test item was investigated for its mutagenic potential in Salmonella th. according to the Ames method. The present study is conducted under GLP and the method applied equivalent to OECD 471.
The test substance was evaluated for mutagenicity in the bacterial reverse mutation test using the plate incorporation method with and without metabolic activation in Salmonella th. strain TA 97a, TA 98, TA 100, TA 102 and TA 1535.
In total 5 concentrations were selected (0.05, 0.158, 0.5, 1.58 and 5 µL/plate) and vehicle as well as a positive controls were run in parallel. In the absence and presence of S9 mix three plates were used for each treatment. Zhe plates were incubated for 48 h at 37°C after the substance was added. Colonies were counted and the mutagenic response evaluated. When the negative results were obtained, a second experiment with changed test condtions (5 times dose spacing; 0.008 to 5 µL/plate) was performed.
The results showed that under the present test conditons all the standards for trsting validity were satisfied. In this experiment, with and without metabolic activation no biologically relevant increase in the mutant count of TA97a, TA 98, TA 100, TA 102 and TA 1535 were reported.
Therefore the test substance is considered to be not mutagenic in the Ames test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
There is no evidence for species specific effects of the substance. Therefore, the results of the in vitro data are regarded as relevant for humans.
Additional information
Justification for classification or non-classification
The registration substance does not have to be not classified for mutagenicity since it did not reveal any mutagenic effect in the bacterial reverse mutation assay in the presence or absence of metabolic activation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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