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EC number: 232-339-7 | CAS number: 8005-52-5 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 29000.
- 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
Under the above-described experimental design, the test substance, Direct Yellow 44, was non mutagenic for the Salmonella typhimurium TA 100 and E. coli without and Salmonella typhimurium TA 1535 with as well as without metabolic activation.
The test substance was mutagenic for Salmonella typhimurium TA 98 and TA 1537 with as well as without metabolic activation, and Escherichia coli with metabolic activation. Signs of mutagenicity occurred repeatedly in experiments in Salmonella typhimurium TA 100 with metabolic activation.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:
- 18.08.2017 – 29.09.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Council Regulation (EC) No.440/2008. Published in O.J. L 142, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- gene for histidine or tryptophan synthesis
- 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:
- supernatant of rat liver and a mixture of cofactors
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500, 5000 μgSelection of doses/toxicity:The test substance was soluble in dimethyl sufoxide - after heating up to 90° it was dissolved up to the highest recommended concentration 5000 µg per 0.1 mL. For toxicity experiment the highest concentration 5 mg per mL (recommended in OECD TG 471) was diluted to the other 5 concentrations in 3 digit places interval. The concentration row was tested for toxicity in strain TA 98 without metabolic activation (see Table B). Precipitation occurred in top agar in the highest concentration 5000 µg per plate. The test substance in background occurred in Petri dishes also in the highest concentration. No toxicity was observed in any dose. Although, precipitation in top agar occurred in the highest concentration, the concentration of 5000 µg per plate was used as maximum in the first mutagenicity experiments. Further doses were diluted with factor approximately 2-√10.No cytotoxicity occurred in the first experiments.Signs of the mutagenicity were observed in some bacterial strains especially in experiments with metabolic activation, so doses for the second mutagenicity experiments were changed for purchase of better dose-response. Doses used for the second mutagenicity experiments were 500-2500 µg per plate. Amount of S9 was increased to 50 µL per plate.In the first mutagenicity experiments in TA 98 with as well as without metabolic activation dose-response as well as doubling of revertants were obtained so the second mutagenicity experiments were not performed.
- Vehicle / solvent:
- dimethyl sulfoxide (DMSO), Merck Lot. No. K48069252 644, exp. 10/2018- Justification for choice of solvent/vehicle: solubility of the substance
- Untreated negative controls:
- yes
- Remarks:
- negative controls - 0.1 mL of DMSO
- Remarks:
- Untreated controls - no solvent
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- (AS)
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- (NPD)
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluorene
- Remarks:
- (2-AF)
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- (2-AA)
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N´-nitro-N-nitrosoguanidine
- Remarks:
- (MNNG)
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine hydrochloride monohydrate
- Remarks:
- (9-AAc)
- Details on test system and experimental conditions:
- The bacterial tester strains Salmonella typhimurium TA 1535 (CCM 3814, lot. No. 2101200916917),TA 98 (CCM 3811, lot No. 01022001220053), TA 100 (CCM 3812, lot No. 0102201220054) and TA 1537 (CCM 3815, lot No. 2101200916918) as well as Escherichia coli WP2 uvrA (CCM 4751, lot No. 2104200512732),were obtained from Czech Collection of Microorganisms (CCM) of Masaryk University, Brno.Strains TA 98 and TA 1537 detect frame shift mutations, strains TA 100 and TA 1535 serve to detection of base-pair substitution mutations, and strain E.coli WP2uvrA detects cross-linking mutagensMETHOD OF APPLICATION: in medium; in agar (plate incorporation)NUMBER OF REPLICATIONS: two seriesDETERMINATION OF CYTOTOXICITY- Method: decrease of number of revertants or diminution of bacterial background
- Evaluation criteria:
- The main criterion for evaluation of results was modified two-fold increase rule, which is compatible with the application of statistical methods (see below). After this rule the result is positive, if a reproducible doseresponse effect occurs and/or a doubling of the ratio Rt/Rc is reached.
- Statistics:
- For the evaluation of results, the modified two-fold increase rule was used, which is compatible with the application of statistical methods:Dunkel V. C.. Chu K.C. (1980): Evaluation of methods for analysis of microbial mutagenicity assays in The Predictive Value of Short-Term Screening Tests in Carcinogenicity Evaluation. Elsevier North-Holland Biomedical Press. 231 - 417Claxton L. D. et al. (1987): Guide for the Salmonella typhimurium/mammalian microsome tests for bacterial mutagenicity. Mutat. Res. 189. 83 - 91
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- 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:
- positive
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not determined
- 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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- HISTORICAL CONTROL DATA: Each experiment included corresponding positive (reference mutagens) and negative controls (untreated control, solvent control). Untreated controls contain no solvent and negative controls contain 0.1 mL of DMSO. All the control numbers were compared with historical ranges of mutant frequencies obtained in our laboratory. The actual numbers were in ranges of the historical numbers.ADDITIONAL INFORMATION ON CYTOTOXICITY:The test substance was soluble in dimethyl sufoxide - after heating up to 90° it was dissolved up to the highest recommended concentration 5000 µg per 0.1 mL. For toxicity experiment the highest concentration 5 mg per mL (recommended in OECD TG 471) was diluted to the other 5 concentrations in 3 digit places interval. The concentration row was tested for toxicity in strain TA 98 without metabolic activation. Precipitation occurred in top agar in the highest concentration 5000 µg per plate. The test substance in background occurred in Petri dishes also in the highest concentration. No toxicity was observed in any dose. Although, precipitation in top agar occurred in the highest concentration, the concentration of 5000 µg per plate was used as maximum in the first mutagenicity experiments. Further doses were diluted with factor approximately 2-√10.No cytotoxicity occurred in the first experiments.
- Conclusions:
- Under the above-described experimental design, the test substance, Direct Yellow 44, was non mutagenic for the Salmonella typhimurium TA 100 and E. coli without and Salmonella typhimurium TA 1535 with as well as without metabolic activation. The test substance was mutagenic for Salmonella typhimurium TA 98 and TA 1537 with as well as without metabolic activation, and Escherichia coli with metabolic activation. Signs of mutagenicity occurred repeatedly in experiments in Salmonella typhimurium TA 100 with metabolic activation.
- Executive summary:
The test substance, Direct Yellow 44, was assayed for the mutagenicity by the Bacterial Reverse Mutation Test. The performed test was based on EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria, which is analogous to the OECD Test Guideline No. 471.
Four indicator Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and one indicator Escherichia coli WP2 uvrA strain were used. The test substance was dispersed in dimethylsulfoxide and assayed in doses of 50 - 5000 μg per plate, which were applied to plates in volume of 0.1 mL.
The first mutagenicity experiments were performed without and with metabolic activation using a supernatant of rat liver (30 μL or 100 per plate) and a mixture of cofactors by the plate incorporation test with a dose range of 50 – 5000 μg per plate.
In the second mutagenicity experiments concentrations were modified because of expectancy of mutagenic effect and to reach prospective dose-response to 500-2500 μg per plate. At experiments with metabolic activation volume of S9 was increased to 50 μL.
The concurrent positive controls verified the sensitivity of the assay and the metabolising activity of the liver preparations. Average revertant colony counts for the vehicle controls were within the current historical control range for the laboratory.
In the arrangement given above, the test substance, Direct Yellow 44, was non mutagenic for the Salmonella typhimurium TA 100 and E. coli without metabolic activation and Salmonella typhimurium TA 1535 with as well as without metabolic activation.
The test substance was mutagenic for Salmonella typhimurium TA 98 and TA 1537 with as well as without metabolic activation, and Escherichia coli with metabolic activation. Signs of mutagenicity occurred repeatedly in experiments in Salmonella typhimurium TA 100 with metabolic activation.
Reference
Additional information
Justification for classification or non-classification
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