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:
April 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study performed in accordance with the corresponding OECD-/EU-testing guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: clear liquid
Details on test material:
- Name of test material (as cited in study report): T1567
- Molecular weight: 177.3
- Freezing point: -45 °F
- Boiling point: 495 °F
- Physical state: brown clear liquid
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: in glass containers in the dark at room temperature

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA1535, TA1537, TA1538, TA98 and TA100
Details on mammalian cell type (if applicable):
- Type and identity of media: Dr. Bruce Ames, Univ.of California, Berkeley, Ca.
- Properly maintained: yes
Additional strain / cell type characteristics:
DNA polymerase A deficient
Metabolic activation:
with and without
Metabolic activation system:
S9-liver fractions of rats induced with Aroclor 1254
Test concentrations with justification for top dose:
1 ul; 0.3 ul; 0.1 ul; 0.03 ul; 0.01 ul/p!ate in the absence and presence of exogenous metabolic activation
Vehicle / solvent:
Sectrophotometric grade dimethylsulfoxide (DMSO, CAS 67-68-5); Lot KHML, obtained from Mallinckrodt Chemical Company, St. Louis, Mo. Dilutions were made on the day required.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-aminoanthracene
Evaluation criteria:
The numbers of revertant colonies from each set of triplicate plates were averaged and the standard deviation calculated. The average number of revertant colonies found in the test compound plates was compared to that found with the solvent control. A compound is considered a mutagen if a dose related increase in the number of revertant colonies is found in the treatment groups. The first dose level considered for the increase must have an average number of revertant colonies which is three times that of the solvent control.

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA1535, TA1537, TA1538, TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
The negative controls, positive controls, and sterility controls all fulfilled requirements for determination of a valid test.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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

No detectable mutagenic activity was found for test article T1567 when the Salmonella/microsomal assay was performed
Executive summary:

This reverse mutation assay was performed in 1980 in accordance with OECD-guidelines without GLP. Five Salm. typh. strains (TA1535, TA1537, TA1538, TA98 and TA100) were tested with and without metabolic activation. Test concentrations ranged from 0.01 ug/plate up to 1 ug/plate.

No detectable mutagenic activity was found for test article T1567 when the Salmonella/microsomal assay was performed