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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no E.coli strain tested
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Test material form:
liquid

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 TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 mix Aroclor 1254 induced (rat liver)
Test concentrations with justification for top dose:
0, 0.0005, 0.001, 0.002, 0.1 µL test liquid/0.1 mL acetone/plate (1st test)
0, 0.0005, 0.001, 0.002, 0.01 µL test liquid/0.1 mL acetone/plate (2nd test)
0, 0.1, 0.25, 0.5, 1.0 (positive control) µg 2-AA/0.1 mL DMSO/plate
Vehicle / solvent:
DMSO and aceton
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Remarks:
All strains with and without metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 3 days at 37 °C

SELECTION AGENT (mutation assays): L-Histidine

NUMBER OF REPLICATIONS: 3


Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
not valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
not valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
not valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
not valid

Any other information on results incl. tables

The addition of 2 -aminoanthracene showed a significant bacterial growth by the addition of S-9 mix, no significant bacterial growth was observed without the addition of S-9 mix. The amount of S-9 mix used was not optimal for the metabolic activation of 2 -AA. The positive control was not valid in this test.

Applicant's summary and conclusion

Conclusions:
The genetic toxicity of the test item was determined in an Ames test equivalent to OECD guideline 471. No genetic toxicity was observed in this study.
Executive summary:

The mutagenic activity of the test item was tested in a study equivalent to OECD guideline 471. A set of 5 histidine requiring mutants of S. typhimurium (TA1535, TA1537, TA 1538, TA 98 and TA100) were used in the Ames-test with and without metabolic activation.

Doses of 0, 0.0005, 0.001, 0.002, 0.1 µL test liquid/0.1 mL acetone/plate (1st test) and 0, 0.0005, 0.001, 0.002, 0.01 µL test liquid/0.1 mL acetone/plate (2nd test) were tested. The strains were incubated over a period of 3 days at 37 °C. Incorporation of the test substance up to non-inhibitory levels did not increase the number of his+ revertants in any of the five tester strains, either in the presence or in the absence of the liver microsome activation system. It was concluded that the present results did not reveal mutagenic acitivity in the Salmonella mutagenicity test.