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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:
The EFMA GRAS assessment of Pyrazine derivatives used as flavor ingredients.
Author:
T.B. Adams, J. Doull, V.J. Feron, J.I. Goodman, L.J. Marnett, I.C. Munro, P.M. Newberne, P.S. Portoghese, R.L Smith, W.J. Waddell, B.M. Wagner.
Year:
2002
Bibliographic source:
Food and Chemical Toxicology, 40, 429-451, 2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
The mutagenic potential of Pyrazine was studied in Salmonella typhimurium strains TA98, TA100, TA102.
GLP compliance:
not specified
Type of assay:
other: not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Details on test material
- Name of test material (as cited in study report): Pyrazine
- Molecular formula (if other than submission substance): C4H4N2
- Molecular weight (if other than submission substance): 80.0896 g/mol
- Substance type: Organic
Specific details on test material used for the study:
Details on test material
- Name of test material (as cited in study report): Pyrazine
- Molecular formula (if other than submission substance): C4H4N2
- Molecular weight (if other than submission substance): 80.0896 g/mol
- Substance type: Organic

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: strains: TA98, TA100, TA102.
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
Not applicable.
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
0.64-64000 µg/plate
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:
Not specified.
Rationale for test conditions:
Not specified.
Evaluation criteria:
Not specified.
Statistics:
Not specified.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: strains: TA98, TA100, TA102.
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:
When mutagenic potential of Pyrazine(230-37-9) was evaluated in Species Salmonella typhimurium strains: TA98, TA100, TA102 with and without metabolic activation i.e. S9 mix, test substance considered to be not mutagenic.
Executive summary:

Mutagenic effect of Pyrazine(230-37-9) was studied in Salmonella typhimurium. Salmonella typhimurium strains TA98, TA100, TA102 were involved in mutagenic assay. Mutagenic assay performed with and without metabolic activation i.e. S9 mix. Test substance in concentration 0.64-64000 µg/plate was tested for mutagenicity.

Test substance did not induce mutation in bacteria Salmonella typhimurium. Therefore Pyrazine was considered to be non mutagenic in Salmonella typhimurium strains: TA98, TA100, TA102 . Hence it is not likely to be classified as genetox in vitro.