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Genetic toxicity: in vitro

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Administrative data

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:
July 12 - 23, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD guidelines and according to GLP principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material Pentaerythritol, reaction product with fatty acids, C8 to 18 (even numbered) and/or branched and/or unsaturated
- Physical state: Pale yellow liquid
- Analytical purity: Not indicated
- Lot/batch No.: OE70406
- Expiration date of the lot/batch: 06 April 2011
- Stability under test conditions: Stable
- Storage condition of test material: In refrigerator (2-8ºC) in the dark

Method

Target gene:
- S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and Escherichia coli (WP2uvrA).
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 33, 100, 333, 1000 and 3330 µg/plate
Concentration range in the main test (without metabolic activation): 33, 100, 333, 1000 and 3330 µg/plate
Vehicle / solvent:
Solvent: Ethanol
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 3330 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: Salmonella typhimurium (TA100) and Escherichia coli (WP2uvrA).
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
other: Salmonella typhimurium (TA1535, TA1537 and TA98)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
other: Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and Escherichia coli (WP2uvrA)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Observations:
All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase
in the number of revertants in two independently repeated experiments.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Comments:
The negative and strain-specific positive control values
were within our laboratory historical control data ranges
indicating that the test conditions were adequate and that
the metabolic activation system functioned properly.


Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments.

Based on the results of this study it is concluded that Pentaerythritol, reaction product with fatty acids, C8 to 18 (even numbered) and/or branched and/or unsaturated is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

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