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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
yes
Remarks:
: only four strains tested
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): RKKO 131006
- Physical state: colorless liquid
- Analytical purity: no data
- Isomers composition: no data
- Storage condition of test material: at room temperature in the dark

Method

Target gene:
his
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix from Aroclor induced rat liver (Litton Bionetics Inc.)
Test concentrations with justification for top dose:
0, 0.1, 0.3, 1.0, 3.0, and 10.0 µl/plate (0.092 - 9.2 mg/plate)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: insolubility of test substance in water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: without S-9: Sodium azide (TA100, TA1537), 5-Nitrofluorene (TA98), 9-Aminoacridine (TA1537); with S-9: 2-Aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 3 days
- Expression time (cells in growth medium): 3 days at 37° C

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; toxicity of the test substance was evaluated in a separate test by incubating tester strain TA100 with 10 graduate concentrations of test substance (0 - 200 µL/plate, spacing factor 2).
Evaluation criteria:
- The solvent/vehicle control has to show an adequate number of revertants.
- A dose-response relationship must be demonstrated at least for one tester strain.
- The maximum number of revertants must be at least double of spontaneous revertants.
- The result must be reproducible.
Statistics:
no data

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 / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Remarks:
no toxicity to TA 100 up to 200 µl/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test substance proved to be insoluble at 12.5 µl and higher, i.e. above recommended maximum test concentration of 5 mg/pl.


Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The test substance did not induce mutant colonies above background in any strain at any concentration tested.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In a bacterial reverse mutation assay using four strains of S. typhimurium, there was no evidence of an increase in revertant colonies above background in any strain and at any concentration tested with and without metabolic activation. Diisopropylnaphthalene proved to be negative in the Ames test under the test conditions used.