11-aminoundecanoic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

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

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

Test material information

Constituent 1

Reference substance name:

11-aminoundecanoic acid

EC Number:

219-417-6

EC Name:

11-aminoundecanoic acid

Cas Number:

2432-99-7

Molecular formula:

C11H23NO2

IUPAC Name:

11-aminoundecanoic acid

Details on test material:

no data

Method

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:

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

Test results 1

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

>1000µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

> 1000 µg/plate

Test results 3

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

>1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1535

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:

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.