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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: IV. Results from the Testing of 300 Chemicals
Author:
Errol Zeiger, Beth Anderson, Steve Haworth, Timothy Lawlor, and Kristien Mortelmans
Year:
1988
Bibliographic source:
Environmental and Molecular Mutagenesis Volume 11, Supplement 12: 1-158 (1988)

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 C. I. Pigment Yellow 74 in Salmonella typhimurium strain TA97, TA98, TA100, TA1535 by AMES test.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
EC Number:
228-768-4
EC Name:
2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
Cas Number:
6358-31-2
Molecular formula:
C18H18N4O6
IUPAC Name:
2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA97, TA98, TA100, TA1535
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:
The S-9 was prepared from fractions of Aroclor 1254-induced, male Sprague- Dawley rat and male Syrian hamster livers.
Test concentrations with justification for top dose:
0,10,33,100,333,667,1000and 2000 ug/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: -S9; sodium azide (TA1535 and TA l00), 9-aminoacridine (TA97), and 4-nitro-o-phenylenediamine (TA98). +S9; For all strains 2-aminoanthracene.
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: Preincubation method,
DURATION
- Exposure duration: two days incubation at 37°C
Rationale for test conditions:
Not specified
Evaluation criteria:
A chemical was judged mutagenic (+) or weakly mutagenic (+ W) if it produced a reproducible dose-related reponse over the solvent control in replicate trials.
A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his+ revertants did not meet the criteria for a “+W” response, or if only single doses produced increases in his+ revertants in repeat trials.Chemicals were judged nonmutagenic (-) if they did not meet the criteria for a mutagenic or questionable response.
Statistics:
Mean ±standard deviation was observed.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA97, TA98, TA100, TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
C. I. Pigment Yellow 74 (6358-31-2)was evaluated for its mutagenic potential in Salmonella typhimurium by AMES test. The test result was considered to be non mutagenic in the presence and absence of metabolic activation.
Executive summary:

Genetic toxicity study was assessed for C. I. Pigment Yellow 74 to evaluate its possible mutagenic potential. For this purpose the test material was exposed to Salmonella typhimurium TA97, TA98, TA100, TA1535 by AMES test. The test material was exposed at the concentration of 0, 10, 33,100,333,667,1000and 2000 ug/plate in the presence and absence of metabolic activation. No mutagenic effects were observed. Therefore C. I. Pigment Yellow 74 was considered to be non mutagenic in the presence and absence of metabolic activation. Hence the substance cannot be classified as gene mutant in vitro.