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EC number: 607-674-0 | CAS number: 25260-60-0
- 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
Ames Test, OECD 471: positive (reference 7.6.1 -1).
Micronucleus test in vitro, OECD 487, screening: negative (reference 7.6.1 -2)
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:
- 2018-06-09 to 2015-07-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- 1993
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- TA 98 (his D 3052, uvrB, rfa + R-factor)
TA 100 (his G 46, uvrB, rfa + R-factor)
TA 1535 (his G 46, uvrB, rfa)
TA 1537 (his C 3076, uvrB, rfa) - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Male Wistar, HSdCpb:Wu rats, aged 6-8 weeks, were given a single intraperitoneal injection of Aroclor 1254 (500 mg/kg body weight) dissolved in Miglyol 812 oil (Merck KGaA, Darmstadt, Germany). The animals received drinking water and a standard diet ad libitum. The body weight of the animals used was 179 g ± 6.76 g.
- method of preparation of S9 mix : according to Ames
- quality controls of S9: Every S9-batch is tested for its metabolic activity by the use of specific substrates, requiring different enzymes of the P450-isoenzyme family. The mutagenicity of 2-aminoanthracene, benzo[a]pyrene, and 3-methylcholanthrene is thus determined once for every S9-batch. - Test concentrations with justification for top dose:
- with and without S9: 5.00, 15.8, 50.0, 158.0, 500.0, 1580.0, 5000.0 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: well solubility of the test item; recommended by the guidelines - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- other: Daunomycin; 2-Aminoanthracene
- Rationale for test conditions:
- According to the guidelines
- Evaluation criteria:
- The assessment of test material-induced effects is dependent on the number of spontaneous revertants of each bacterial strain (solvent controls) and the increase in the number of revertants at the test material concentration which shows the highest number of colonies. The criteria provided in table 1 in "any other information on materials and methods", based upon the historical controls of the laboratory and statistical considerations, were established.
Interpretations:
A test material was to be defined as negative or non-mutagenic in this assay if
• the assay was to be considered valid, and
• "no" or "weak increases" occurred in the test series performed ("weak increases" randomly occur due to experimental variation)
For valid data, the test material was considered to be positive or mutagenic if:
• the assay was to be considered valid, and
• a dose dependent (over at least two test material concentrations) increase in the number of re-vertants was induced, the maximal effect was a "clear increase", and the effects were reproduced at similar concentration levels in the same lest system or
• "clear increases" occurred al least at one test material concentration, higher concentrations showed strong precipitation or cytotoxicity, and the effects were reproduced at the same concentration level in the same test system. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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 and time of the determination: no precipitation observed - Conclusions:
- Under the conditions of this study the test item is considered mutagenic in procaryotic cells.
- Executive summary:
The investigations for the mutagenic potential of the test item were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. Two independent experimental series were performed. In the two series with S9 mix, 10 % S9 in the S9 mix were used in the 1st and 30 % in the 2nd series, respectively.
All test item treatments in this study were performed using formulations prepared in anhydrous analytical grade dimethyl sulphoxide (DMSO). Treatments of all tester strains were performed in the absence and in the presence of S9 mix, using final concentrations of the test item between 5 and 5000 µg/plate, plus vehicle and positive controls. After test material exposure, no precipitation of the test material on the agar plates occurred and no toxicity to the bacteria was observed.
Daunomycin, sodium azide, 9-aminoacridine, and 4-nitroquinolin-N-oxide served as strain specific positive control test materials in the absence of S9 mix. 2-Aminoanthracene was used as positive control in the presence of the metabolic activation and thus for testing the activity of the S9 mix.
Vehicle and positive control treatments were included for all strains. The mean numbers of revertant colonies all fell within acceptable ranges for vehicle control treatments, and were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
Under the conditions of this assay, there were relevant increases in revertant numbers after test item exposure observed in TA 100 in the absence of S9 mix in both series.
Therefore, the test material is considered mutagenic under the described experimental conditions.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2015-09-14
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Remarks:
- Only short report avilable, only screening test was conducted
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- Deviations:
- yes
- Remarks:
- only screening test was conducted
- Principles of method if other than guideline:
- The in vitro micronucleus assay is a mutagenicity test system used for the detection of chemicals that induce the formation of small membrane-bound DNA fragments, such as micronuclei, in the cytoplasm of interphase cells. The assay has the potential to detect the activity of both clastogenic and aneugenic chemicals. Micronuclei were detected by using the In Vitro MicroFlow® method (Litron Laboratories, Rochester, NY, USA). The relevant limit of cytotoxicity is determined by the most sensitive parameter (RPD, RICC or RS).
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian cell micronucleus test
- Species / strain / cell type:
- human lymphoblastoid cells (TK6)
- Metabolic activation:
- with and without
- Metabolic activation system:
- rodent liver S9 mix
- Test concentrations with justification for top dose:
- 5, 10, 20, 25, 27.5, 30, 32, 35, 35.5, 40, 63.1, 112 µg/mL
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- other: Grisoefulvin
- Key result
- Species / strain:
- human lymphoblastoid cells (TK6)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- Under the conditions of this test the test item was not mutagenic.
- Executive summary:
The objective of this screening assay was to assess the mutagenic potential of the test item. The in vitro micronucleus assay is a mutagenicity test system used for the detection of chemicals that induce the formation of small membrane-bound DNA fragments, such as micronuclei, in the cytoplasm of interphase cells. The assay has the potential to detect the activity of both clastogenic and aneugenic chemicals. Micronuclei were detected by using the In Vitro MicroFlow® method (Litron Laboratories, Rochester, NY, USA). The relevant limit of cytotoxicity is determined by the most sensitive parameter (RPD, RICC or RS).
The test item showed a very steep cytotoxicity response. The test item showed a micronucleus induction at one concentration near the limit of cytotoxicity only, which could not be reproduced in a second experiment. Therefore, this effect is considered to be of no biological relevance. The test item was thus concluded to be not mutagenic in this screening test system in the absence or presence of the metabolic activation (S9 mix).
Referenceopen allclose all
Please refer to background material attached.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ames Test (reference 7.6.1 -1)
The investigations for the mutagenic potential of the test item were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. Two independent experimental series were performed. In the two series with S9 mix, 10 % S9 in the S9 mix were used in the 1st and 30 % in the 2nd series, respectively.
All test item treatments in this study were performed using formulations prepared in anhydrous analytical grade dimethyl sulphoxide (DMSO). Treatments of all tester strains were performed in the absence and in the presence of S9 mix, using final concentrations of the test item between 5 and 5000 µg/plate, plus vehicle and positive controls. After test material exposure, no precipitation of the test material on the agar plates occurred and no toxicity to the bacteria was observed.
Daunomycin, sodium azide, 9-aminoacridine, and 4-nitroquinolin-N-oxide served as strain specific positive control test materials in the absence of S9 mix. 2-Aminoanthracene was used as positive control in the presence of the metabolic activation and thus for testing the activity of the S9 mix. Vehicle and positive control treatments were included for all strains. The mean numbers of revertant colonies all fell within acceptable ranges for vehicle control treatments, and were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used.
Under the conditions of this assay, there were relevant increases in revertant numbers after test item exposure observed in TA 100 in the absence of S9 mix in both series.
Therefore, the test material is considered mutagenic under the described experimental conditions.
Micronucleus Test in vitro, screening test (reference 7.6.1 -2)
The objective of this screening assay was to assess the mutagenic potential of the test item. The in vitro micronucleus assay is a mutagenicity test system used for the detection of chemicals that induce the formation of small membrane-bound DNA fragments, such as micronuclei, in the cytoplasm of interphase cells. The assay has the potential to detect the activity of both clastogenic and aneugenic chemicals. Micronuclei were detected by using the In Vitro MicroFlow® method (Litron Laboratories, Rochester, NY, USA). The relevant limit of cytotoxicity is determined by the most sensitive parameter (RPD, RICC or RS).
The test item showed a very steep cytotoxicity response. The test item showed a micronucleus induction at one concentration near the limit of cytotoxicity only, which could not be reproduced in a second experiment. Therefore, this effect is considered to be of no biological relevance. The test item was thus concluded to be not mutagenic in this screening test system in the absence or presence of the metabolic activation (S9 mix).
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are not sufficient for final conclusion
on classification under Regulation (EC) No 1272/2008. An in vitro
mutation assay in bacteria revealed a positive result, whereas an in
vitro screening test on cytogenicity in mammalian cells was negative.
Based on the available data no conclusion can be made regarding
classification and labelling as mutagen according to Regulation (EC) No
1272/2008 (CLP), as amended for the twelfth time in Regulation (EU)
2019/521.
The test item is registered as transported isolated intermediate according to REACH Art. 17/18 .Consequently, there is no concern in regards to human or environmental exposure. Therefore, further hazard assessment is legally and scientifically not required.
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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