3-(allyloxy)propane-1,2-diol

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:

10 October - 12 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

Plate Incorporation method

Deviations:

yes

Remarks:

During the Confirmatory Mutation Test the incubation time was 21 minutes instead of 20 minutes in one case

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-(allyloxy)propane-1,2-diol

EC Number:

204-620-4

EC Name:

3-(allyloxy)propane-1,2-diol

Cas Number:

123-34-2

Molecular formula:

C6H12O3

IUPAC Name:

3-(allyloxy)propane-1,2-diol

Test material form:

liquid

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

activated rat liver S9

Test concentrations with justification for top dose:

5000, 1581, 500, 158.1, 50 and 15.81 μg/plate

Vehicle / solvent:

Distilled water

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

other: 4-nitro-1,2-phenylene-diamine

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

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

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 6

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Based on the results of the Preliminary Concentration Range Finding Test, the test item concentrations were in the Initial Mutation Test (plate incorporation) with and without metabolic activation in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA strains 5000, 1581, 500, 158.1, 50 and 15.81 μg/plate. In the Confirmatory Mutation Test (pre-incubation) the examined test item concentrations were with and without metabolic activation in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA strains 5000, 1581, 500, 158.1, 50, 15.81 and 5 μg/plate. In the Complementary Initial Mutation Test (plate incorporation) the examined concentrations were in Salmonella typhimurium TA1535 strain without metabolic activation 5000, 3750, 2500, 1250, 625 and 312.5 μg/plate. In the case of Salmonella typhimurium TA1535 strain without metabolic activation, in the Initial Mutation Test a slight positive was observed, in the Complementary Initial Mutation Test a clear, reproducible positive effect was obtained using the plate incorporation method.

Precipitate of the test item was not detected in the Preliminary Concentration Range Finding Test and in the main tests.

No inhibitory, cytotoxic effect of the test item was observed in the preliminary experiment and in the main tests.

The mean values of revertant colonies of the solvent control plates were within the historical control range, the reference mutagens showed the expected increase in the number of revertant colonies, the viability of the bacterial cells was checked by a plating experiment in each test. At least five analysable concentrations were presented in all strains of the main tests.

Applicant's summary and conclusion

Conclusions:

The test item had mutagenic activity in Salmonella typhimurium TA1535 bacterial strains without metabolic activation. No mutagenic activity was observed in Salmonella typhimurium TA98, TA100, TA1537 and Escherichia coli WP2 uvrA bacterial strains with and without metabolic activation and Salmonella typhimurium TA1535 with metabolic activation under the test conditions used in this study.

Executive summary:

The potential mutagenic activity has been assessed using the Bacterial Reverse Mutation Assay (Ames test) according to OECD 471 and in compliance with GLP. The test item had mutagenic activity in Salmonella typhimurium TA1535 bacterial strains without metabolic activation. No mutagenic activity was observed in Salmonella typhimurium TA98, TA100, TA1537 and Escherichia coli WP2 uvrA bacterial strains with and without metabolic activation and Salmonella typhimurium TA1535 with metabolic activation under the test conditions used in this study.