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EC number: 204-373-2 | CAS number: 120-14-9
- 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
Ames test (OECD TG 471): negative combining two separate tests
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:
- 1985-1986
- 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)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- - S. typhimurium: Histidine gene
- Species / strain / cell type:
- other: TA1535, TA1537, TA98 and TA100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat and hamster metabolic activation system.
- Test concentrations with justification for top dose:
- - Dose range finding test:
The test item was initially tested with strain TA100 in the presence and absence of metabolic activation over a wide dose range with an upper limit of 10 mg/plate. As a rule, at least one toxic dose was incorporated into the first mutagenicity test.
Five concentration were used in this study, ranging from 0.1 to 6.6 mg/plate. - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: the test substance was found to be soluble in DMSO - Untreated negative controls:
- yes
- Remarks:
- (untreated plates)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- potassium chloride
- Positive controls:
- yes
- Remarks:
- 2-aminoanthracene was used with all strains with metabolic activation
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine
- Details on test system and experimental conditions:
- Preincubation assay
Mutagenicity was tested in the preincubation assay. The mixture of S-9 mix or buffer, the overnight culture and the solvent of test chemical was allowed to incubate for 20 min at 37'C, at which time molten top agar was added, supplemented with L-histidine or D-biotin. The content of the tubes was mixed and poured onto minimal glucose bottom agar in petri dishes. When the top agar solidified, the plates were incubated at 37'C for 48 h.
Concurrent solvent and positive controls were tested with and without metabolic activation. Five dose levels of test item were tested, with three plates per dose level.
In this study E. coli was not used, neither TA102 strain. Therefore, this study is used in combination with another study in a WoA approach. - Evaluation criteria:
- The criteria used for data evaluation, were as follows: 1) mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold; 2) nonmutagenic response: when no increase in the number of revertants was elicited by the chemical.
- Key result
- Species / strain:
- other: TA1535, TA1537, TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 6.6 mg/plate.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In all strains toxicity was observed at the highest dose of 6.6 mg/plate.
5 concentrations were used for each strain, which resulted in at least 4 analyzable concentrations up to 3333 ug/plate (in some cases the highest dose of 6666 ug/plate was toxic). - Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay performed according to OECD 471.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471. The test was performed in a pre-incubation assay, both in the absence and presence of S9-mix. The dose levels were selected based on observed cytotoxicity in dose setting experiment. Adequate negative and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in any of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100), neither in the absence nor in presence of S9-metabolic activation. Based on the results of this study, it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- - S. typhimurium: Histidine gene
- Species / strain / cell type:
- other: TA100, TA102 and TA104
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced liver S9 mix from F344 rats and B6C3F1 mice.
- Test concentrations with justification for top dose:
- Test item was tested at the concentration range of 33-3333 ug/plate. No number of doses applied in the test was mentioned in the publication. The highest dose was limited by toxicity, determined by thinning of the background lawn or a reduction in the number of colonies on the plates, or both.
- Vehicle / solvent:
- No information provided
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- mitomycin C
- other: formaldehyde or crotonaldehyde for TA104; 2-amino anthracene was used for all strains with S9.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
The test item was tested in a preincubation protocol. The highest dose was limited by toxicity, which was assesed based on below criteria.
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain.
DETERMINATION OF CYTOTOXICITY
- Method: determined by thinning of the background lawn or a reduction in the number of colonies on the plates, or both.
Numerous details of the study were not mentioned in the publication, like the number of applied doses, cytotoxicity presence and degree, solvent or negative controls. Therefore, this study is used in combination with another study in a WoE approach. - Evaluation criteria:
- For the test substance to be considered mutagenic, positive responses had to be reproducible and dose-related.
- Statistics:
- The significance of mean revertant counts at individual dose levels was assessed using Dunnett's t-test and dose-response effects were analysed by two methods, Wahrendorf ranking and linear regression.
- Key result
- Species / strain:
- other: TA100, TA102 and TA104
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay performed similar to OECD 471.
- Executive summary:
The mutagenic activity of the substance was evaluated in a study performed similar to OECD 471. The test was performed in a pre-incubation assay, both in the absence and presence of S9-mix. The highest dose was limited by toxicity. Adequate positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in any of the three S. typhimurium tester strains (TA100, TA102 and TA104), neither in the absence nor in presence of S9-metabolic activation. Based on the results of this study, it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Two studies are used for this endpoint, because none of the studies covers the whole range of necessary bacterial strains. Two studies described below complement each other, as one included the following strains: TA1535, TA1537, TA98 and TA100 (not including the necessary E. coli WP2 or alternative TA102) and the other included the following ones: TA100, TA102 and TA104, therefore TA102 strain is covered.
Mortelmans:
The mutagenic activity of the substance was evaluated in accordance with OECD 471. The test was performed in a pre-incubation assay, both in the absence and presence of S9-mix. The dose levels were selected based on observed cytotoxicity in dose setting experiment. Adequate negative and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in any of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100), neither in the absence nor in presence of S9-metabolic activation. Based on the results of this study, it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Dillon:
The mutagenic activity of the substance was evaluated in a study performed similar to OECD 471. The test was performed in a pre-incubation assay, both in the absence and presence of S9-mix.The highest dose was limited by toxicity.Adequate positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in any of the three S. typhimurium tester strains (TA100, TA102 and TA104), neither in the absence nor in presence of S9-metabolic activation. Based on the results of this study, it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Justification for classification or non-classification
Based on the results of the Ames test, the substance does not have to be classified for mutagenicity in accordance with EU CLP and its amendments (1272/2008).
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