Registration Dossier

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:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD 471. Study conducted under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- NAME OF TEST SUBSTANCE: ASTA-C15-ACETAL (C15-ACL)
- SUBSTANCE NUMBER: 94/29
- LOT NUMBER: 25656/133 S
- DATE OF MANUFACTURING: 07-FEB-1994
- PHYSICAL STATE/APPEARANCE: LIQUID, OILY, YELLOW
- STORAGE CONDITIONS: ROOM TEMPERATURE, EXCLUSION OF LIGHT

Method

Target gene:
his
Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S-9 fractions.
Test concentrations with justification for top dose:
20; 100; 500; 2,500; 5,000 ug/plate
Vehicle:
DMSO
Details on test system and conditions:
Tester strains, doses, number of plates

1st Experiment:
- Strains: TA 1535, TA 100, TA 1537, TA 98
- Doses: 0, 20, 100, 500, 2500 and 5000 ug/plate
- Vehicle: DMSO
- Type of test test conditions: standard plate test with and withtout S-9 mix
- Number of plates: 3 test plates per dose or per control

2nd Experiment:
- Strains: TA 1535, TA 100, TA 1537, TA 98
- Doses: 0, 20, 100, 500, 2500 and 5000 ug/plate
- Vehicle: DMSO
- Type of test, test conditions: preincubation test with and without S-9 mix
- Number of plates: 3 test plates per dose or per control
Evaluation criteria:
In general, a substance to be characterized as positive in the AMES test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- close-response relationship
- reproducibility of the results.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
other: Bacteriotoxicity observed in the standard plate test with TA 1537 at 5,000 ug/plate (+/- S-9 mix) and TA 100 at doses >= 500 ug/plate (only + S-9 mix).
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
According to the results of the present study, the test substance Asta-C15-Acetal (C15-Acl) is not mutagenic in the AMES Test under the experimental conditions chosen here.