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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
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
1983 followed, reliability scoring based on 1997 guideline.
Deviations:
yes
Remarks:
Salmonella typhimurium TA102 or Escherichia coli-WP2 uvrA strain not tested; 2-aminoanthracene was the only compound used to test the efficacy of the S9 fraction.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Grilonit RV 1806
- Analytical purity: Not reported
- Lot/batch No.: EH 5871/12
- Storage condition of test material: room temperature

Method

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 applicable
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9
Test concentrations with justification for top dose:
Pre-Experiment: 1, 3, 10, 33, 100, 333, 1000 and 5000 µg/plate (± S9)
Experiment: 10.0, 100.0, 333.3, 1000.0 and 5000.0 µg/plate (± S9)


Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: see Table 1
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 72 hours at 37°C

NUMBER OF REPLICATIONS: 3 plates per test; no independent repeat experiment performed.

Evaluation criteria:
A test substance is considered as mutagen if, in strain TA 100, the number of reversions is at least twice as high with two concentrations of the substance, and in strains TA 1535, TA 1537, TA 1538, and TA 98, it is at least three times higher with two concentrations of the test substance as compared to the spontaneous reversion rate. If in a repeated experiment there is a clear increase in the reversion rate by factors as indicated even in only one strain, then this also leads to the substance being classified as a mutagen.
Also, a continuous dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic properties of the test substance, regardless whether the highest dose induces the above described enhancement factors or not. Such findings would perhaps not be sufficient to declare the substance mutagenic. However, it recommends further testing to exclude mutagenicity.
Statistics:
Revertant colony numbers were calculated as average and standard deviation. No statistical analysis test was performed.

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:
positive
Remarks:
TA 1535, TA 98 and TA 100
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
but tested up to limit concentrations.
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
without metabolic activation
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
but tested up to limit concentrations.
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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

The test article was not toxic up to the highest dose of 5000.0 µg/plate in all strains.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive with metabolic activation in strains TA 1535, TA 98 and TA 100
positive without metabolic activation in strains TA 1535, TA 1538, TA 98 and TA 100