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EC number: 288-422-3 | CAS number: 85721-12-6
- 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 mutagen
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Colipa report n. C174
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- other: Mouse Lymphoma
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- uninduced Syrian golden hamster liver homogenate
- Test concentrations with justification for top dose:
- 156.3, 312.5, 625, 1250, 2500, 5000 μg/ml with and without S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: DMNA
- Details on test system and experimental conditions:
- 4 hours treatment
- Species / strain:
- other: all strains
- 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:
- Not mutagenic
- Executive summary:
There is no indication of increase in mutation frequency induced by the substance in both experiments in the absence of metabolic activation and in the second experiment in the presence of metabolic activation.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Source: Dr. Bruce N.Amex (University of Berkeley, California).
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- Source: Dr. Bruce N.Amex (University of Berkeley, California).
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 50, 250 and 1000 µg/plate
- Vehicle / solvent:
- water or DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: nitroquinoline-N-oxide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: anthragallol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-antrhamine
- Details on test system and experimental conditions:
- Plate tests. Plates containing various concentrations of the test agents incorporated with the top agar and in some cases 100--200 pg of the test agent contained in a 0.25-inch sterile concentration disk applied to the top agar were incubated 3 days at 35 ° .
In addition many of the azo dyes dissolved and plated as described above were incubated for 16 h at 37 ° in an anaerobic glove box similar in most respects to that described by
Aranki et al. [3]. These were subsequently incubated for 3 days in the normal {aerobic) fashion. - Species / strain:
- other: all strains
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Not mutagenic
- Executive summary:
The results of this study indicate that the tested dye is not mutagenic in the Salmonella / microsome test.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Primary reference with few details on methods and results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Source: B.N. Ames, Biochemistry Department, University of California, Berkeley.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 3.3, 1.65 and 0.165 mg/plate
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- Two of the histidine requiring mutants (TA98 and TA1537) were developed for the detection of frame-shift mutagens and the other two (TA100 and TA1535) base-pair substituted mutants. Strains TA98 and 100 contained the resistance-transfer factor which made them more sensitive to a wide range of mutagens [1]. Upon receipt of the strains they were cultured
and checked for histidine requirements; crystal violet and ampicillin sensitivity; and mutagenicity with 9-aminoacridine, 2- aminofluorine, and Nmethyl- N-nitro-N'-nitrosoguanidine.
At regular' intervals during the tests the cultures were checked to determine if they displayed the original mutant phenotype. Permanent stock cultures of each strain were made by adding
dimethyl sulfoxide (DMSO) to nutrient broth cultures; the cultures ere quickly frozen in alcohol-dry ice bath and stored at -74°C in a Revco freezer.
Fresh cultures were obtained as described by Ames et al. except the cultures were grown at 37°C on a roller drum at a speed of 50 r.p.m. - Statistics:
- The statistical sampling used in this study was a twostage, double sampling scheme for estimating binomial (yes/no) data with misclassifications (Tenenbein, 1970).
- Species / strain:
- other: TA98, TA100, TA1535 and TA1537
- 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:
- not specified
- Conclusions:
- Not mutagenic
- Executive summary:
The results of this study indicate that the tested dye is not mutagenic in all tested strains in the Ames mutagenicity test.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Primary reference with few details on methods and results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- other: TA98, TA100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 50, 250 and 1000 µg/plate
- Vehicle / solvent:
- water or DMSO
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- Chemicals were tested in a preincubation procedure in strains TA98 and TA100 without metabolic activation and with activation provided by Aroclorinduced rat and hamster liver homogenates (S9).
If a positive response was seen in one of these two strains, the strain/metabolic activation combination producing that response was repeated, and no further testing was performed. If no positive responses were seen, the chemical was tested in strains TA97 and TA1535 - Statistics:
- The statistical sampling used in this study was a twostage, double sampling scheme for estimating binomial (yes/no) data with misclassifications (Tenenbein, 1970).
- Species / strain:
- other: TA98 and TA100
- 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:
- not specified
- Conclusions:
- Not mutagenic
- Executive summary:
The results of this study indicate that the tested dye is not mutagenic in the Ames mutagenicity test.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Not mutagen
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- other: MNT
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 30 mice were used for the experiment (6 mice per treatment, positive control, and negative control group).
Animals were purchased at 6 weeks of age from Charles River Laboratories, Japan and were acclimatized for 7 days before treatments. Food (CRF-1 pellet feed, Oriental Yeast, Japan) and water were provided ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- 0.5% carboxymethylcellulose sodium
- Details on exposure:
- oral gavage
- Frequency of treatment:
- the test article and the negative control were orally administered daily for 2 days with a 24-h interval using stomach tubes and plastic syringes.
Dosing formulations of thempositive control substance were administered in a single intraperitoneal injection using a disposable syringe fitted with a 25-G needle. - Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 30 mice were used in experiments:
6 mice in each of the 3 dose groups
6 mice in the positive control groups
6 mice in the negative control groups. - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitocymin C dissolved in water for injection.
- Statistics:
- Frequencies of MNPCEs in treatment and positive control groups were compared with those in the negative control group using conditional binomial tests (Kastenbaum and Bowman test, uppertailed significance level of 0.05).
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No deaths and no clinical signs of toxicity were observed in any of the treatment groups.
No differences in body weight were observed between control and treatment groups at the end of treatment.
In micronucleus tests, no significant differences in MNPCEs were found between the treated groups and the negative control group.
The frequency of PCEs, which offers an index of the influence of the test substance on bone marrow cells, did not differ between any of the treatment groups and the negative control group.
In contrast, the frequency of MNPCEs in the positive control group was markedly increased in comparison with that in the negative control group. - Conclusions:
- Not mutagen
- Executive summary:
The tested substance did not show any mutagenic effect in the in vivo micronucleous test performed according OECD 474.
- Endpoint:
- genetic toxicity in vivo, other
- Remarks:
- TRG assay
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- other: MNT
- Species:
- mouse
- Strain:
- other: Muta Mice
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- In total, 28 mice were used for the experiment (6 mice per treatment and negative control groups and 4 mice in the positive control group).
Male Muta™ Mice (CD2-LacZ80/HazfBR) were purchased at 9 weeks of age from Japan Laboratory Animals, Inc., Japan and were acclimatized for 11 days before treatments. Food (CRF-1 pellet feed, Oriental Yeast, Japan) and water were provided ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- water for injection
- Details on exposure:
- oral gavage
- Frequency of treatment:
- the test article and the negative control were orally administered daily for 2 days with a 24-h interval using stomach tubes and plastic syringes.
Dosing formulations of them positive control substance were administered in a single intraperitoneal injection using a disposable syringe fitted with a 25-G needle. - Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 28 mice were used in experiments:
6 mice in each of the 3 dose groups
6 mice in the positive control groups
4 mice in the negative control groups. - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 7, 12-dimethylbenz[a]anthracene was mixed with olive oil
- Tissues and cell types examined:
- Mice were sacrificed by CO2 asphyxiation 3 days after the last treatment. Subsequently, liver and stomach tissues were collected, stomach tissues were divided into forestomach and glandular stomach, and genomic DNA was extracted from liver and glandular stomach samples according to the reported methods.
- Statistics:
- Differences in MFs were analyzed for significance by the Conditional Binomial test (Kastenbaum and Bowman method: upper tailed significance level of 0.05).
The results were evaluated as positive when the mutant frequency in the test substance treated group was significantly different from that in the negative control group. - Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No deaths and no clinical signs of toxicity were recorded in any of the treatment groups. In addition, body weight gains during treatment were the same in all treatment groups.
MFs of cII genes in liver and glandular stomach tissues from the treated animals were not significantly higher than those in respective negative control animals.
In contrast, the positive control DMBA significantly increased MFs in the liver and MFs were slightly but insignificantly induced in stomach tissues.
However, these weak response may be adequate as positive control in TGR assay. - Conclusions:
- Not mutagen
- Executive summary:
The tested substance did not show any mutagenic effect in the in vivo mutagenicity test performed according OECD 488.
- Endpoint:
- genetic toxicity in vivo, other
- Remarks:
- Comet assay
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- other: comet assay
- Species:
- mouse
- Strain:
- other: [CD2F1/Crlj (CDF1), SPF/VAF]
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- In total, 25 mice were used in experiments, including 5 mice in each of the 3 dose groups and 5 each in the positive and negative control groups.
Animals were purchased at the age of 8 weeks from Charles River Laboratories, Japan. Animals were acclimatized for 8 days before the start of the treatments.
Food (CE-2 pellet feed, CLEA Japan) and water were provided ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Details on exposure:
- oral gavage
- Frequency of treatment:
- 2 application
The test chemical and the negative control substance were orally administered 2 times using stomach tubes and plastic syringes at 24 h and 3 h before tissue sampling. - Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 25 mice were used in experiments:
5 mice in each of the 3 dose groups
5 mice in the positive control groups
5 mice in the negative control groups. - Control animals:
- yes, concurrent no treatment
- Positive control(s):
- Ethylmethanesulphonate dissolved in physisological saline.
- Statistics:
- Mean percentages of tail DNA were compared between each treatment group and the negative control group using Dunnett's multiple comparison test (1-tailed), and differences were considered significant when p < 0.05 and p < 0.01.
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No deaths and no clinical signs of toxicity were observed in any of the treatment groups.
No significant differences in numbers of hedgehogs or DNA damages were observed in either organ between the treated animals and negative control animals.
In contrast, the positive control (EMS) group showed significant increases in percentages of DNA in Comet tails from both organs. - Conclusions:
- Not mutagen
- Executive summary:
The tested substance does not show any significant differences in numbers of hedgehogs and no DNA damages were observed both in treated and negative control animals.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
There are different in vitro and in vivo studies performed on similar substance:
In vitro Ames test (OECD 471) - negative in different studies and
different strains both with and without metabolic activation
In vitro Moude Lymphoma test (OECD 476) - negative
In vivo Comet assay (OECD 489) - negative
In vivo MNT (OECD 474) - negative
In vivo TRG assay (OECD 488) - negative
Based on the in vitro and in vivo studies results, it could be concluded that the tested substance is not mutagen.
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