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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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been conducted to OECD guidelines and to GLP, and therefore meets the criteria for Klimisch code 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test substance was an analog of CAS 70024-69-0 described as C20-24 alkaryl calcium salt derivative.

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
araclor
Test concentrations with justification for top dose:
0.1, 0.33, 1.0, 3.33 and 10 mg/plate
Vehicle / solvent:
pluronic F127 in ethanol
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 3/dose group/strain/treatment set

Evaluation criteria:
Number of revertant colonies.
Statistics:
Mean revertant colony count and standard deviation for each dose point.

Results and discussion

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: No reduction in the number of revertants/plate was observed in the rangefinding study with strains TA100 and WP2uvrA.


ADDITIONAL INFORMATION ON CYTOTOXICITY: No cytotoxicity was observed in the dose rangefinding study with strains TA100 and WP2uvrA with or without metabolic activation.

Any other information on results incl. tables

No cytotoxic response was seen in the dose range finding study.

The positive control exhibited at least a 3 fold increase in revertant colonies.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test material was not mutagenic to Salmonella and E. Coli strains with and without metabolic activation.
Executive summary:

In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA1535 and TA 1537 of S. typhimurium and E. coli WP2uvrA were exposed to an analog of C20-C24 alkaryl calcium salt derivative, at concentrations of 100, 330, 1000, 3330 and 10000 µg/plate in the presence and absence of mammalian metabolic activation. 

 

The positive controls induced the appropriate responses in the corresponding strains.   There was no evidence of induced mutant colonies over background.

 

This study is classified as acceptable.  This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.