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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.

Data source

Reference
Reference Type:
secondary source
Title:
Draft Screening Assessment: Aromatic Azo and Benzidine-based Substance Grouping - Certain Azo Solvent Dyes
Author:
Environment Canada - Health Canada; November 2013
Year:
2013
Bibliographic source:
Draft Screening Assessment Certain Azo Solvent Dyes 2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of Solvent Yellow 18 in Salmonella Typhimurium TA98, TA100 by modified AMES test.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one
EC Number:
229-043-5
EC Name:
4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one
Cas Number:
6407-78-9
Molecular formula:
C18H18N4O
IUPAC Name:
4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one
Test material form:
solid: crystalline
Details on test material:
- Name of test material (IUPAC name): 4-[(E)-2-(2,4-dimethylphenyl)diazen-1-yl]-3-methyl-1-phenyl-4,5-dihydro-1H-pyrazol-5-one
- Common name: Solvent Yellow 18
- Molecular formula: C18H18N4O
- Molecular weight: 306.367 g/mol
- Smiles notation: O=C1N(N=C(C)[C@@H]1\N=N\c1c(cc(cc1)C)C)c1ccccc1
- InChl: 1S/C18H18N4O/c1-12-9-10-16(13(2)11-12)19-20-17-14(3)21-22(18(17)23)15-7-5-4-6-8-15/h4-11,17H,1-3H3/b20-19+
- Substance type: Organic
- Physical state: Solid

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98, TA100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 metabolic activation containing flavin-mononucleotide (FMN)
Test concentrations with justification for top dose:
Not specified
Vehicle / solvent:
Not specified
Controls
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:
Method of application: Pre incubation
Rationale for test conditions:
Not specified
Evaluation criteria:
Not specified
Statistics:
Not specified

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 100
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
Additional information on results:
Not specified
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
The mutagenicity of Solvent Yellow 18 was tested in modifying Ames test in S. typhimurium strainsTA98 and TA100 under standard and reductive (with FMN) conditions and with metabolic activation. Positive results were observed in strain TA98, regardless of the presence of FMN, and the results were negative in strain TA100, with and without FMN
Executive summary:

The mutagenicity of Solvent Yellow 18 was tested in modifying Ames test in S. typhimurium strains TA98 and TA100 under standard and reductive (with FMN) conditions and with metabolic activation. Positive results were observed in strain TA98, regardless of the presence of FMN, and the results were negative in strain TA100, with and without FMN. Therefore Solvent Yellow 18 result for this test was considered to be ambiguous.