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EC number: 616-632-0 | CAS number: 78564-87-1
- 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 test substance showed an increase in revertant colony numbers in strain TA 100 in the presence of S9 mix.
As the relevance of this effect for humans cannot be evaluated from this result, an in-vivo Comet Assay was proposed as follow-up of the positive effect.
Link to relevant study records
- 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:
- 2021-09-14 till 2021-09-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Since a positive result was obtained in experiment I, a second experiment with non-induced hamster liver S9 mix as exogenous metabolic activation system was not performed. - Vehicle / solvent:
- Solvent used: DMSO
Justification for choice of solvent: best suitable solvent, because of its solubility properties and its relative nontoxicity to the bacteria - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation
DURATION:
NUMBER OF REPLICATIONS: 3 plates for each concentration including the controls
DETERMINATION OF CYTOTOXICITY: Evident as a reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants of twofold or above (strains TA 98, TA 100, and WP2 uvrA) or threefold or above (strains TA 1535 and TA 1537) the spontaneous mutation rate of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is reached or exceeded at more than one concentration.
An increase of revertant colonies equal or above 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 threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- 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
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- up to 2.2-fold at 2500 µg/plate
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- 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
Effects of pH: none
Water solubility: not soluble
Precipitation: The test item precipitated in the overlay agar in the test tubes at 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 1000 to 5000 µg/plate. The undissolved particles had no influence on the data recording.
Other confounding effects: none
COMPARISON WIT HISTORICAL CONTROL DATA: performed, no deviations
ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains with and without S9 mix, except of strain TA 1535 in the presence of S9 mix. - Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by base pair changes in the genome of strain TA 100 in the presence of S9 mix.
- Executive summary:
This study was performed to investigate the potential of Disperse Red 153 to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed with and without liver microsomal activation (S9 mix). The experiment was performed with induced rat liver S9 mix as an exogenous metabolic activation system. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes at 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 1000 to 5000 µg/plate. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain
Experiment I
without S9 mix
with S9 mix
TA 1535
5000
/
TA 1537
2500 – 5000
5000
TA 98
5000
5000
TA 100
5000
5000
WP2 uvrA
2500 – 5000
2500 – 5000
/ = no toxic effects (induction factor ≥ 0.5)
A substantial and dose depended increase in revertant colony numbers was observed following treatment with Disperse Red 153 in strain TA 100 in the presence of S9 mix. The relevant threshold of two-fold the revertant colony count of the corresponding solvent control was exceeded at a concentration from 1000 to 2500 µg/plate. Based on overlapping toxic effects the number in revertant colony count decreased below the threshold of toxicity at the highest concentration.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
Reference
Summary of Experiment I
Study Name: 2183806 | Study Code: ICCR 2183806 |
Experiment: 2183806 HV1 Plate | Date Plated: 14.09.2021 |
Assay Conditions: | Date Counted: 17.09.2021 |
Metabolic Activation | Test Group | Dose Level (per plate) |
| Revertant Colony Counts (Mean ±SD) TA 1535 | Revertant Colony Counts (Mean ±SD) TA 1537 | Revertant Colony Counts (Mean ±SD) TA 98 | Revertant Colony Counts (Mean ±SD) TA 100 | Revertant Colony Counts (Mean ±SD) WP2 uvrA |
Without Activation | DMSO |
|
| 10 ± 1 | 12 ± 0 | 33 ± 7 | 130 ± 24 | 41 ± 11 |
| Untreated |
|
| 10 ± 5 | 10 ± 3 | 36 ± 10 | 117 ± 19 | 46 ± 7 |
| Disperse Red | 3 µg |
| 10 ± 4 | 11 ± 1 | 39 ± 3 | 125 ± 6 | 47 ± 7 |
| 153 | 10 µg |
| 14 ± 3 | 13 ± 6 | 28 ± 5 | 131 ± 13 | 55 ± 8 |
|
| 33 µg |
| 12 ± 2 | 9 ± 2 | 28 ± 6 | 133 ± 24 | 50 ± 7 |
|
| 100 µg |
| 12 ± 3 | 7 ± 2 | 28 ± 9 | 128 ± 15 | 49 ± 1 |
|
| 333 µg |
| 14 ± 3 | 10 ± 3 | 26 ± 9 | 108 ± 12 | 30 ± 3 |
|
| 1000 µg |
| 9 ± 3 P M | 7 ± 2 P M | 17 ± 2 P M | 98 ± 8 P M | 22 ± 3 P |
|
| 2500 µg |
| 7 ± 0 P M | 5 ± 1 P M | 18 ± 3 P M | 61 ± 7 P M | 13 ± 1 P M |
|
| 5000 µg |
| 4 ± 2 P M | 2 ± 1 P M | 6 ± 1 P M | 7 ± 2 P M | 9 ± 1 P M |
| NaN3 | 10 µg |
| 1096 ± 105 |
|
| 1448 ± 68 |
|
| 4-NOPD | 10 µg |
|
|
| 714 ± 70 |
|
|
| 4-NOPD | 50 µg |
|
| 96 ± 12 |
|
|
|
| MMS | 2.0 µL |
|
|
|
|
| 813 ± 81 |
|
|
|
|
|
|
|
|
|
With Activation | DMSO |
|
| 11 ± 1 | 13 ± 3 | 50 ± 9 | 111 ± 10 | 57 ± 6 |
| Untreated |
|
| 15 ± 6 | 15 ± 1 | 53 ± 12 | 120 ± 20 | 70 ± 7 |
| Disperse Red | 3 µg |
| 12 ± 2 | 11 ± 3 | 54 ± 6 | 112 ± 9 | 51 ± 10 |
| 153 | 10 µg |
| 13 ± 2 | 14 ± 2 | 52 ± 8 | 133 ± 13 | 69 ± 2 |
|
| 33 µg |
| 13 ± 4 | 11 ± 3 | 58 ± 14 | 137 ± 13 | 64 ± 6 |
|
| 100 µg |
| 11 ± 4 | 11 ± 3 | 57 ± 8 | 185 ± 34 | 66 ± 13 |
|
| 333 µg |
| 9 ± 2 | 12 ± 2 | 69 ± 9 | 209 ± 26 | 60 ± 3 |
|
| 1000 µg |
| 11 ± 0 P | 10 ± 4 P | 62 ± 11 P | 234 ± 15 P | 42 ± 5 P |
|
| 2500 µg |
| 7 ± 3 P M | 8 ± 2 P M | 45 ± 7 P M | 245 ± 26 P M | 20 ± 6 P M |
|
| 5000 µg |
| 9 ± 3 P M | 6 ± 2 P M | 17 ± 5 P M | 46 ± 8 P M | 5 ± 1 P M |
| 2-AA | 2.5 µg |
| 348 ± 12 | 539 ± 24 | 2543 ± 167 | 3126 ± 68 |
|
| 2-AA | 10.0 µg |
|
|
|
|
| 290 ± 9 |
|
|
|
|
|
|
|
|
|
Key to Plate Postfix Codes:
P: Precipitate
M: Manuel Count
Key to positive controls:
NaN3: sodium azide
4 -NOPD: 4 -nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
2-AA: 2 -aminoanthracene
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Disperse Red 153
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: no in vivo studies are available to adequately address this endpoint.
- Available non-GLP studies: no in vivo studies are available to adequately address this endpoint.
- Historical human/control data: There is no historical human data available for this substance on ‘genetic toxicity in vivo’. Hence no evidence of human adverse effect.
- (Q)SAR: (Q)SARs are not considered adequate to address this endpoint.
- In vitro methods: there are no adequate in-vitro methods to address this endpoint.
- Weight of evidence: in absence of additional data no WoE can be done.
- Grouping and read-across: no analogues were identified with data on genotoxicity that were considered relevant to read across.
- Substance-tailored exposure driven testing: not applicable.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The ECHA guidance R.7a states that following a positive result in an in vitro test, “adequately conducted somatic cell in vivo testing is required to ascertain if this potential can be expressed in vivo.”
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design: According to OECD 489 in liver, glandular stomach and duodenum of one sex only, as no toxicologically relevant differences were observed between males and females.
No germ cells will be collected, as the assay is not validated for germ cells, the TG states "this guideline is not considered appropriate to measure DNA strand breaks in mature germ cells. Since high and variable background levels in DNA damage were reported in a literature review on the use of the comet assay for germ cell genotoxicity". - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- GLP compliance:
- yes
- Type of assay:
- mammalian comet assay
- Species:
- rat
- Sex:
- male
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 2 treatments (24 h and 4 h prior to preparation)
- Frequency of treatment:
- 2 treatments
- Post exposure period:
- 24 h and 4 h
- No. of animals per sex per dose:
- 6 (one sex, as there is no gender difference)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- yes
- Tissues and cell types examined:
- A) Analysis of hepatocytes
Isolation of hepatocytes by mincing
Determination of dead cells in 500 cells per slide (1500 per animal)
Performance of the alkaline comet assay
Analysis of 50 cells per slide (150 cells per animal)
B) Analysis of cells from the stomach
Isolation of cells from the stomach by scraping
Determination of dead cells in 500 cells per slide (1500 per animal)
Performance of the alkaline comet assay
Analysis of 50 cells per slide (150 cells per animal)
C) Analysis of cells from small intestine
Isolation of cell nuclei from the small intestine by mincing
Determination of dead cells in 500 cells per slide (1500 per animal)
Performance of the alkaline comet assay
Analysis of 50 cells per slide (150 cells per animal)
Reference
Additional information
This study was performed to investigate the potential of Disperse Red 153 to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed with and without liver microsomal activation (S9 mix). The experiment was performed with induced rat liver S9 mix as an exogenous metabolic activation system. Each concentration, including the controls, was tested in triplicate. The test item was tested at concentrations of 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes at 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 1000 to 5000 µg/plate. The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at concentrations of 2500 and/or 5000 µg/plate in all strains with and without S9, except is TA 1535, were toxicty was only observed without S9.
An increase in revertant colony numbers was observed following treatment with Disperse Red 153 in strain TA 100 in the presence of S9 mix. The relevant threshold of two-fold the revertant colony count of the corresponding solvent control was exceeded at a concentration from 1000 to 2500 µg/plate. Based on overlapping toxic effects the number in revertant colony count decreased below the threshold of toxicity at the highest concentration.
Justification for classification or non-classification
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.