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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant study, performed according to OECD testing guideline 471. Non-standard test strain

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
TA 1538 used instead of E.coli strain
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: red
- Physical state: solid

- Purity test date: no data
- Lot/batch No.: AL 56/37+38
- Expiration date of the lot/batch: December 31, 1988
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark

- Other: stable for at least 2 hours in H20, polyethylene glycol, CMC, and dimethylformamid

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium, other: TA 1538
Additional strain / cell type characteristics:
other: his G 46; rfa-; uvrB-; :base-pair substitutions
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S9
Test concentrations with justification for top dose:
10; 100; 333.3; 1000; and 5000 µg/plate
Vehicle / solvent:
DMF
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: TA 1535, TA 100: sodium azide; TA 1537, TA 1538, TA 98: 4-nitro-o-phenylene-diamine
Remarks:
without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Remarks:
with metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

The assay was performed in two independent experiments, using identical procedures, both with and without· liver microsomal activation. Each concentration, including the controls, was tested in triplicate.

Evaluation criteria:
A test article is considered as mutagen if in strain TA 100 the number of reversions is at least twice as high and in strains
TA 1535, TA 1537, TA 1538, and TA 98 it is at least three times higher as compared to the spontaneous reversion rate.

Also, a dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential
of the test article regardless whether the highest dose induced the above described enhancement factors or not.

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 nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium, other: TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Only weak toxic effects, evidenced by a reduction in the number of spontaneous revertants, occurred in some of the test groups with and without metabolic activation at the highest investigated dose.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative