Dodecyl 5-oxo-L-prolinate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyl 5-oxo-L-prolinate

EC Number:

245-224-1

EC Name:

Dodecyl 5-oxo-L-prolinate

Cas Number:

22794-26-9

Molecular formula:

C17H31NO3

IUPAC Name:

dodecyl 5-oxo-L-prolinate

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Test concentrations with justification for top dose:

To assess the toxicity of the test item, 6 dose-levels were tested in the TA 98, TA 100 and TA 102 strains, with and without 9S mix. Th evaluation of the toxicity war performed on the basis of the observation of the decrease in the number of revertant colonies and/ or thinning of the bacterial lawn.

Without S9 mix, a moderate to strong toxicity was noted at dose levels = 100 %g/ plate towards the three strains used.
With S9 mix, a moderate to strong toxicity was noted at dose levels = 500 µg/ plate for the TA 100 and TA 102 strains, and at dose levels = 2500 µg/ plate for the TA 98 strain.

Since the test item was toxic in the premiminary test, the choice of the highest dose-level was based on the level of toxicity, according to the criteria specified in the international guidelines

The selected treatment levels for experiments without S9- mix were :
- 0.78, 1.56, 3.13, 6.25, and 12.5 µg/ plate, for the TA 1537 strain in the first experiment
- 1.56, 3.13, 6.25, 12.5, 25, and 50 µg/plate for the TA 102 strain in the first experiment as well as for the TA 1535, TA 1537, TA 98, and TA 100 strains in the second experiment
- 3.13, 6.25, 12.5, 25 and 50 µg/plate for the TA 102 strain in the second experiment
- 6.25, 12.5, 25, 50 and 100 µg/ plate for the TA 1535, TA 98, and TA 100 strains in the first experiment.

The selected treatment levels for experiments with S9- mix were :
- 12.5, 25, 50, 250, and 500 µg/ plate, for the TA 102 strain in the second experiment
- 25, 50, 100, 250, and 500 µg/ plate for the TA 102 strain in the first experiment, for the TA 98 and TA 1537 strains in the second experiment and for the TA 1535 and TA 100 strains in both experiments
- 50, 100, 250, 500 and 1000 µg/plate, for the TA 1537 and TA 98 strains in the first experiment

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

mitomycin C

other: 2-Anthramine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium;
- in agar (plate incorporation)
- preincubation

DURATION
- Preincubation period: 60 min at 37°C for strains with S9 mix
- Exposure duration: 48 to 72 hours of incubation at 37 °C

Evaluation criteria:

A reproducible 2-fold increase (for the TA 98, TA100, and TA 102 strains) or 3-fold increase (for the TA 1535, and TA 1537 strains) 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 bioligical relevance may also be taken into account in the evaluation of the data obtained

Results and discussion

Test results

Key result

Species / strain:

other: all strains

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: A moderate to marked toxicity was noted towards all the strains used, generally at dose-levels = 250 µg/ plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. Under test conditions, the test item did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.

Remarks on result:

other: See additional information section

Applicant's summary and conclusion

Conclusions:

Under experimental conditions, the test item Laurydone did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.

Based on OECD 471 GLP compliant study, results are considered scientifically valid to be used to support a non classification.