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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:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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): DIMETHYLDIALLYLAMMONIUM CHLORIDE (MONOMER)
- Molecular formula (if other than submission substance): C8H16N.Cl
- Molecular weight (if other than submission substance): 161.68
- Smiles notation (if other than submission substance): C(=C)CN{+}(c)(c)(.Cl{-})CC=C
- InChl (if other than submission substance): 1/C8H16N.ClH/c1-5-7-9(3,4)8-6-2;/h5-6H,1-2,7-8H2,3-4H3;1H/q+1;/p-1
- Substance type: organic
- Physical state: colourless liquid
- Composition of test material, percentage of components: aqueous solution at 50%
- Lot/batch No.: EP 4000 950708-1
- Storage condition of test material: at room temperature.

Method

Target gene:
Histidine operon (TA 1535 His G46, TA 100 His G46, TA 102 His G 428 (pQ1), TA 1537 His C3076, TA98 His D 3052)
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 TA 102
Metabolic activation:
with and without
Metabolic activation system:
rat liver microsomal fraction (S9 fraction)
Test concentrations with justification for top dose:
312.5, 625, 1250, 2500, 5000 ug/plate.
Vehicle / solvent:
distilled water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
distilled water
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Without S9 mix : Sodium azide (NaN3), 9-Aminoacridine (9AA), 2-Nitrofluorene (2NF), Mitomycin C (MMC). With S9 mix 2-Anthramine (2AM)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation
DURATION
- Preincubation period: test substance solution (0.05 to 0.1 ml), S9 mix (0.5 ml) and bacterial suspension (0.1 ml) were incubated for 60 minutes at 37°C
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: 3
Evaluation criteria:
A reproducible two-fold increase in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.

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
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
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

PRELIMINARY TOXICITY TEST

The test substance was supplied as a solution in distilled water at 50% (500 mg/ml). Consequently, with a maximum dose volume of 100 ul/plate, the dose-Ievels were: 10, 100, 500, 1000, 2500 and 5000 ug/plate. No precipitate was observed in the Petri plate when scoring the revertants. No toxicity was noted towards the three strains used, with and without S9 mix.

MUTAGENICITY EXPERIMENTS

The number of revertants of the vehicle and positive controls was as specified in the acceptance criteria and within the range of our historical data. Since the test substance was non-toxic, freely soluble, the highest dose-level was 5000 ug/plate, according to the criteria specified in the international regulations. The selected treatment-levels were: 312.5, 625, 1250, 2500, 5000 ug/plate. The test substance did not induce any significant increase in the number of revertants, with and without S9 mix, in any of the five strains.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance did not induce any significant increase in the number of revertants, with and without S9 mix, in any of the five straïns and is therefore considered to be negative in the Ames test.