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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:
data not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2c: comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no assay was performed on strain allowing detection of certain oxidising mutagens, cross-linking agents and hydrazines like E. coli WP2 uvrA, E. coli WP2 uvrA pKM101 or S. typhimurium TA102
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Method

Species / strain
Species / strain / cell type:
other: Strains TA98, TA100, TA 1535, 1537 and 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 from induced Aroclor 1254 Sprague-Dawley rat liver
Test concentrations with justification for top dose:
0, 50, 100, 250, 500, 750 and 1000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: sterile distilled water
- Justification for choice of solvent/vehicle: The maximal solubility was obtained with sterile distilled water at 50°C and an aqueous solution was thus obtained at 2mg/ml.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: without metabolic activation: ethyl methane sulfonate (TA1535); amino acridine (TA1537); nitrofluorene (TA 1538 and 98). with metabolic activation: 2-anthramine (TA 98); methyl methane sulfonate (TA 100).
Remarks:
A cytotoxicity control was performed on strain TA 98
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; in agar (plate incorporation)

DURATION
- Exposure duration: 48 h
Evaluation criteria:
Mutagenic activity is evaluated with the number of revertant colonies. Since a 50 % increase in the number of spontaneous revertant colonies is observed, the test is considered as positive.
Statistics:
none.

Results and discussion

Test results
Species / strain:
other: Strains TA98, TA100, TA 1535, 1537 and 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
With metabolic activation : > 1000 µg/plate Without metabolic activation : > 1000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No data
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

No significant increase in the number of revertant his + was detected on strains TA 1535, TA 1537, TA 98, TA 100 with and without metabolic activation.
Executive summary:

In a reverse gene mutation assay on bacteria (IFREB, 1982), strains of Salmonella typhimurium (TA 1535, TA 1537, TA 1538, TA 98 and TA 100) were exposed to 11 aminoundecanoic acid at concentration of 0, 50, 100, 250, 500, 750 and 1000 µg/plate in the presence or absence of mammalian metabolic activation. Within the positive controls performed, all induced the appropriate responses in the corresponding strains. No northworthy increase in the number of revertant colonies was induced in all tested strains with and without metabolic activation. Therefore, 11 aminoundecanoic acid does not show any mutagenic activity in the bacterial reverse test. This study is classified as reliable with restriction. It satisfies OECD requirements for the test OECD 471 except in that no strain allowing detection of certain oxidising mutagens, cross-linking agents and hydrazines like E. coli WP2 uvrA, E. coli WP2 uvrA pKM101 or S. typhimurium TA 102 were used here. Moreover all positive control were done systematically in condition with metabolic activation.