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Toxicological information

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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1983-01-27 to 1983-02-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study appears to be in general accordance with OECD guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
While the study report does not provide a specific statement regarding whether this study was conducted according to GLP or equivalent, the study appears to be in general accordance with OECD guidelines.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Alkenes, C10/C11/C12/C13
IUPAC Name:
Alkenes, C10/C11/C12/C13
Details on test material:
- Name of test material (as cited in study report): Olefin 103 PQ/II
- Substance type: Alkenes C10/C11/C12/C13
- Physical state: Yellow liquid

Method

Target gene:
Not specified
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
Saccharomyces cerevisiae
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
31.25, 62.5, 125, 250, 500, I000, 2000 or 4000 ug/plate for Ames assay; 0.01, 0.1., 0.5, 1.0 or 2.0 mg/mL for Saccharomyces cerevisiae gene conversion assay
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Ethanol/Tween 80
- Justification for choice of solvent/vehicle: Not provided
Details on test system and experimental conditions:
METHOD OF APPLICATION: In agar (plate incorporation)


DURATION
- Exposure duration: 48-72 hours; 3 days for Saccharomyces cerevisiae






Evaluation criteria:
Number of revertant colonies were counted in the Ames assay; number of prototrophic colonies were counted in the Saccharomyces cerevisiae gene conversion assay
Statistics:
Statistical methods, if employed, are not reported in the study

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
Saccharomyces cerevisiae
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
The cell survival in yeast was decreased in relation to dose in the absence of S9. Cell survival was relatively unaffected in the presence of S9.
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Olefin 103 PQ/11 did not cause an increase in the reverse mutation rates in bacteria or in the mutation gene conversion rates in yeast in the presence or absence of metabolic activation. The cell survival in yeast was decreased in relation to dose in the absence of S9. Cell survival was relatively unaffected in the presence of S9.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Olefin 103 PQ/11 did not cause an increase in the reverse mutation rates in bacteria or in the mutation gene conversion rates in yeast in the presence or absence of metabolic activation.
Executive summary:

In a mutagenicity test procedure, three separate assays were used to determine the mutagenic potential of Olefin 103 PQ/11. Following an initial preliminary toxicity test, the main mutagenicity test was conducted in Salmonella typhimurium strains, TA1537, TA1535, TA100 and TA98 and Escherichia coli WP2 uvrA, both in the presence and absence of rat liver fraction S9, at 31.25, 62.5, 125, 250, 500, I000, 2000 or 4000 µg per plate. The cultures were incubated at 37°C for 48-72 hours before the revertant colonies were counted.

 

The test material was also tested in Saccharomyces cerevisiae. Liquid suspension cultures of log-phase cells of Saccharomyces cerevisiae JDI were dosed with of 0.01, 0.1., 0.5, 1.0 or 2.0 mg/mL, both in the presence and in the absence of rat liver S9 fraction. After 18 hours incubation at 30°C in the absence of S9 fraction, or 2hours at 37°C followed by 16 hours at 30°C in the presence of S9 fraction, the cultures were seeded onto the appropriate culture media for the selection of prototrophic colonies. After 3 days incubation at 30°C, the numbers of prototrophic colonies were counted.

 

Olefin 103 PQ/11 did not cause an increase in the reverse mutation rates in bacteria or in the mutation gene conversion rates in yeast in the presence or absence of metabolic activation. The cell survival in yeast was decreased in relation to dose in the absence of S9. Cell survival was relatively unaffected in the presence of S9. Positive controls indicated that the test systems were working appropriately. 

 

This study received a Klimisch score of 2 and is classified as “reliable with restrictions” because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study appears to be in general accordance with OECD guidelines.