Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 220-509-3 | CAS number: 2786-76-7
- 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 registered substance did not cause genotoxic effects in bacteria (OECD 471,Ames-Prival) and mammalian cells (OECD 476, HGPRT & OECD 473, chromosomal aberration test in V79 cells)
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 24 OCT 2007 to 28 FEB 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 473), GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2000/32/EC, L1362000, Annex 4A, dated May 19, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: supplemented MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 extract from phenobarbital/beta-naphthoflavone induced Wistar rats
- Test concentrations with justification for top dose:
- without metabolic activation (P: precipitation occurred)
Experiment 1: 2.0, 3.9, 7.8 (P), 15.6 (P), 31.3 (P), 62.5 (P), 125.0 (P), 250.0 (P) µg/ml
Experiment 2a: 0.13, 0.25, 0.5, 1.0 (P), 2.0 (P), 3.9 (P) µg/ml
Experiment 2b: 0.5, 1.0 (P), 2.0 (P), 3.9 (P) µg/ml
with metabolic activation (P: precipitation occured)
Experiment 1: 2.0, 3.9, 7.8 (P), 15.6 (P), 31.3 (P), 62.5 (P), 125.0 (P), 250.0 (P) µg/ml
Experiment 2: 1.0, 2.0, 3.9, 7.8 (P), 15.6 (P), 31.3 (P), 62.5 (P), 125.0 (P) µg/ml
Not all test groups were evaluated (for evaluation points see executive summary) - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle: solubility properties and low toxicity to cell cultures - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- Two independent experiments were performed:
Experiment 1 with an exposure duration of 4 h without and with metabolic activation and chromosome preparation 18 h after start of treatment
Experiment 2 with an exposure duration of 18 and 28 h (each without metabolic activation) and chromosome preparation 18 h and 28 h after start of treatment, respectively as well as an exposure duration of 4 h (with metabolic activation) and chromosome preparation at 28 h after start of treatment. Two parallel cultures were analysed per group.
METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: without S9 mix: 4, 18 and 28 h; with S9 mix: 4 h
- Fixation time (start of exposure up to fixation or harvest of cells): without S9 mix: 18 and 28 h; with S9 mix: 18 and 28 h
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): GIEMSA
NUMBER OF CELLS EVALUATED: 100 metaphase cells per slide (200 per dose from two independent cultures)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cell numbers - Evaluation criteria:
- A test item is classified as non-clastogenic if:
-the number of induced structural chromosome aberrations in all evaluated dose groups is in the range of our historical control data (0.0 - 4.0 % aberrant cells, exclusive gaps). and/or
-no significant increase of the number of structural chromosome aberrations is-observed.
A test item is classified as clastogenic if:
-the number of induced structural chromosome aberrations is not in the range of our historical control data (0.0 - 4.0 % aberrant cells, exclusive gaps).
and
-either a concentration-related or a significant increase of the number of structural chromosome aberrations is observed.
However, both biological and statistical significance should be considered together. If the criteria mentioned above for the test item are not clearly met, the classification with regard to the historical data and the biological relevance is discussed and/or a confirmatory experiment is performed.
Although the inclusion of the structural chromosome aberrations is the purpose of this study, it is important to include the polyploids and endoreduplications. The following criteria is valid:
A test item can be classified as aneugenic if:
-the number of induced numerical aberrations is not in the range of our historical control data (0.0 - 5.2.% polyploid cells). - Statistics:
- Statistical significance was confirmed by means of the Fisher's exact test (p < 0.05).
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no relevant effect
- Effects of osmolality: no relevant effect
- Precipitation: observed at concentrations >=7.8 µg/mL (with S9 mix, Experiment I & II), >=1.0 µg/mL (without S9 mix, Experiment II) and >=7.8 µg/mL (without S9 mix, Experiment I)
RANGE-FINDING/SCREENING STUDIES:
No clear cytotoxicity was observed in the range-finding pre-test (test concentrations up to 250 µg/mL).
COMPARISON WITH HISTORICAL CONTROL DATA:
Results were within the range of historical control values
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxicity was not observed up to the highest concentrations tested (250 µg/mL) - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item did not induce structural chromosome aberrations in V79 Chinese Hamster lung cells in vitro without or with metabolic activation in this study. - Executive summary:
The test item (suspended in DMSO) was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in vitro in two independent experiments according to OECD TG 473. The highest applied concentration was determined in a pre-test on cytotoxicity and technical aspects (precipitation).
The following study design was performed with 2 independent cultures per group:
without S9 mix
with S9 mix
exp. I
exp. II
exp. I
exp. II
Exposure period
4 hrs
18 hrs
28 hrs
4 hrs
4 hrs
Preparation interval
18 hrs
18 hrs
28 hrs
18 hrs
28 hrs
The following concentrations were tested (evaluated experimental points in bold letters):
without metabolic activation:
Experiment 1: 2.0, 3.9, 7.8 (P), 15.6 (P), 31.3 (P), 62.5 (P), 125.0 (P), 250.0 (P) µg/ml
Experiment 2a: 0.13, 0.25 , 0.5, 1.0 (P), 2.0 (P), 3.9 (P) µg/ml
Experiment 2b: 0.5, 1.0 (P), 2.0 (P), 3.9 (P) µg/ml
with metabolic activation:
Experiment 1: 2.0, 3.9, 7.8 (P), 15.6 (P), 31.3 (P), 62.5 (P), 125.0 (P), 250.0 (P) µg/ml
Experiment 2: 1.0, 2.0, 3.9, 7.8 (P), 15.6 (P), 31.3 (P), 62.5 (P), 125.0 (P) µg/ml
P: precipitation occured
No toxic effects indicated by reduced mitotic indices or reduced cell numbers were observed after treatment with the test item, but precipitation occured as indicated above.
100 metaphase per culture (i.e. 200 metaphase per concentration) were scored for structural chromosome aberrations. In both independent experiments, no biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item.
No relevant increase in the frequencies of polyploid metaphases was found after treatment with the test item as compared to the frequencies of the controls.
Therefore, the test item was not clastogenic in this in vitro assay.
Appropriate mutagens were used as positive controls. They induced statistically significant increases in cells with structural chromosome aberrations.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From30 OCT 2007 to 16 JAN 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 476), GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- HPRT
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:supplemented MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix from phenobarbital/beta-naphthoflavone pretreated Wistar rats
- Test concentrations with justification for top dose:
- without S9 mix:
Experiment I: 2.0, 3.9, 7.8, 15.6, 31.3 (P), 250 (P) µg/ml
Experiment II: 3.9, 7.8, 15.6 (P), 31.3 (P), 62.5 (P), 125 (P) mg/ml
With S9 mix:
Experiment I: 2.0, 3.9, 7.8, 15.6 (P), 31.3 (P), 250 (P) µg/ml
Experiment IA: 7.8, 15.6, 31.3 (P), 62.5 (P), 125 (P), 250 (P) µg/ml
Not all test groups were evaluated (for evaluation points see executive summary) - Vehicle / solvent:
- - DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: Experiment I and Experiment IA: 4 h, experiment II: 24 h
- Expression time (cells in growth medium): 24 h
- Selection time (if incubation with a selection agent): 8 days
- Fixation time (start of exposure up to fixation or harvest of cells): 3+7+8 days
SELECTION AGENT (mutation assays): 6-thioguanine
NUMBER OF REPLICATIONS: 2 experiments, treatments performed in duplicate, both with and without metabolic activation
NUMBER OF CELLS EVALUATED: colonies with more than 50 cells
DETERMINATION OF CYTOTOXICITY
- Method: colony formation - Evaluation criteria:
- A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response at one of the test points.
A test item producing neither a concentration- related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered non-mutagenic in this system.
A positive response is described as follows:
A test item is classified as mutagenic if it reproducibly induces a mutation frequency that is three times above the spontanous mutation frequency at least at one of the concentrations in the experiment.
The test item is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed.
However, in a case by case evaluation this decision depends on the level of the corresponding negative control data. If there is by chance a low spontanous mutation rate in the range normally found (0.5-31.8 mutants per 10 to the power of 6 cells) a concentration-related increase of the mutations within this range has to be discussed. The variability of the mutation rates of negative and solvent controls within all experiments of this study was also taken into considration. - Statistics:
- A linear regression was performed to assess a possible dose dependent increase of mutant frequencies.
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- only in experiment I without metabolic activation at the maximum concentration (250 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
Experiment I: from 31.3 to 250.0 µg/ml without metabolic activation, from 15.6 to 250.0 µg/ml with metabolic activation (Exp I) and from 31.3 to 250 µg/ml with metabolic activation (Exp IA)
Experiment II: from 15.6 to 125 µg/ml
RANGE-FINDING/SCREENING STUDIES:
A pre-test was performed with concentrations ranging from 2.0 to 250.0 µg/ml - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance did not increase the mutant frequency at the HPRT locus in Chinese hamster V79 cells and is therefore considered to be non-mutagenic under the conditions of the test. - Executive summary:
The test item was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster according to OECD TG 476.
Chinese hamster V79 cells were treated with the test substance in the following concentrations:without S9 mix:
Experiment I: 2.0, 3.9, 7.8, 15.6, 31.3 (P), 250 (P) µg/ml
Experiment II: 3.9, 7.8, 15.6 (P), 31.3 (P), 62.5 (P), 125 (P) µg/ml
With S9 mix:
Experiment I: 2.0, 3.9, 7.8, 15.6 (P), 31.3 (P), 250 (P) µg/ml
Experiment IA: 7.8, 15.6, 31.3 (P), 62.5 (P), 125 (P), 250 (P) µg/ml
Marked in bold: cultures which were not continued.
In experiment I and IA the treatment period was 4 h with and without metabolic activation. The second experiment was performed in the absence of metabolic activation with a treatment time of 24 h.
A precipitation of the test substance was noted in experiment I from 15.6 or 31.3 to 250 µg/ml and in experiment II from 15.6 to 125 µg/ml. The solvent control gave mutant frequencies within the normal range. The positive controls gave marked increases in the mutant frequency, indicating the satisfactory performance of the test system. The test substance demonstrated no statistically significant or dose related increases in mutant frequency at any dose level, either with or without metabolic activation, thus indicating that the test item is not mutagenic under the conditions tested.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 09 NOV 2004 to 07 DEC 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG471) with Prival modification for azo-dyes, GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2000/32/EC, L1362000, Annex 4D
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- 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:
- rat liver S9 or hamster liver S9
- Test concentrations with justification for top dose:
- Experiment I (Plate incorporation method): 0, 3, 10, 33, 100, 333, 1000, 2500, 5000 µg/plate
Experiment II (Pre-incubation method):0, 10, 33, 100, 333, 1000, 2500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle/ Solvent used: DMSO
- Justification for choice of solvent/ vehicle: solubility properties and its relative non-toxicity to the bacteria - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (TA 1535 and TA 100), 4-Nitro-o-phenylene-diamine (TA 1537 and TA 98), methyl methane sulfonate (WP2 uvrA)
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation (rat liver S9 mix)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (TA 1535, TA 100, TA 1537 and WP2 uvrA), congo red (TA98)
- Remarks:
- with metabolic activation (hamster liver S9 mix)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment I: plate incorporation method without and with induced rat liver S9 mix (induction with phenobarbital/beta-naphthoflavone)
Experiment II: pre-incubation method without and with non-induced hamster liver S9 mix.
DURATION:
-preincubation period (experimentII): 30 °C, for 30 min
- exposure duration: 48 h at 37 °C in the dark
NUMBER OF REPLICATIONS: 3 plates per strain and dose level including the controls - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, WP2 uvrA) or thrice (strains TA 1535, TA 1537) the colony count of the corresponding solvent colony is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the thresshold is regarded as an indication of mutagenic potential if reproduced in an independent second experiment. however, whenever the colony counts remain within the historical range of negative annd solvent controls such as an increase is not considered biologically relevant. - Statistics:
- Arithmetic mean, standard deviation and the ratio of treated versus solvent were calculated .
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- minor toxic effects at concentrations of 2500 and 5000 µg/plate (for details see below)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- minor toxic effects at concentrations of 2500 and 5000 µg/plate (for details see below)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Did not occurr in experiment I at all, but in experiment II without activation (1000-5000 mg/plate) and with activation (2500-5000 µg/plate for T1535, TA 1537, TA 98, WP2uvrA, and 1000-5000 µg/plate for TA 100).
Nevertheless undissolved particles had no influence on the data recording.
COMPARISON WITH HISTORICAL CONTROL DATA: The number of colonies is slightly above the historical control range in strains TA 1535 (negative control, exp.I) and WP2 uvrA (solvent control, exp.I) without S9 mix and in strain WP2 uvrA (negative and solvent control, exp.I) with S9 mix. Since this deviation is rather small, this effect is considered to be based upon biologically irrelevant fluctuations in the number of colonies.
The historic range of positive controls was exceeded with metabolic activation in strains TA 1535 (exp.II) and WP2 uvrA (expI). This effect indicates the sensitivity of the strains rather than compromising the assay.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- minor toxic effects at concentrations of 2500 and 5000 µg/plate: reduced background growth in experiment I in all strains with and without metabolic activation; in experiment II in strain TA1535 and 1537 with metabolic activation - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item did not exert mutagenic activity in the reverse bacterial mutation assay (plate incorporation assay and pre-incubation assay according to Prival) with and without metabolic activation. - Executive summary:
Mutagenic activity of the test item was investigated in Salmonella typhimurium strains TA 1535, TA 1537, TA98 and TA100 as well as Escherichia coli strain WP2 uvrA with (induced rat liver S9 mix) and without metabolic activation at concentrations of 0, 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate using the plate incorporation assay.
Due to the test items characteristic as an azo-dye the test was also conducted using the Prival modification, i.e. testing the above mentioned bacterial strains in the preincubation assay without and with uninduced hamster liver S9 mix for metabolic activation. This test was performed using the following concentrations: 0, 10, 33, 100, 333, 1000, 2500, 5000 µg/plate.
The test item did not reveal any mutagenic activity under the conditions tested. The appropriate reference mutagenes showed distinct positive mutagenic effects.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification
The registered substance did not cause genotoxic effects in bacteria or mammalian cells in vitro.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.