1,3-Propanediol, 2-[2-(2-amino-6-chloro-9H-purin-9-yl)ethyl]-, 1,3-diacetate

Genetic toxicity: in vitro

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:

17.6.1993 - 16.7.1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no E. coli or equivalent Salmonella strain tested

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Method

Target gene:

his

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538

Metabolic activation:

with and without

Metabolic activation system:

liver microsomal fraction (S9)

Test concentrations with justification for top dose:

First experiment: 8, 40, 200, 1000 and 5000 µg/plate with and without metabolic activation
Second experiment: 312.5, 625, 1250, 2500 and 5000 µg/plate with and without metabolic activation

Vehicle / solvent:

- Vehicle/solvent used: dimethyl sulphoxide (DMSO)

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with S9: N-Ethyl-N'-nitro-N-nitrosoguanidine (TA100 and TA1535), 9-Aminoacridine (TA1537), 4-Nitro-o-phenylenediamine (TA1538), 4-Nitroquinoline-1-oxide (TA98); without S9: 2-Aminoanthracene (TA1535), Benzo(a)pyrene (all other strains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: Three replications each in two independent assays.

DETERMINATION OF CYTOTOXICITY
- Method: observation of background lawn

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test substance was observed up to doses of 5000 µg/plate in any of the tester strains.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The test substance caused no reduction in the growth of the bacterial lawn at any of the dose levels employed in any of the strains of Salmonella tested. The test substance was, therefore, tested up to the maximum recommended dose of 5000 µg/plate.

No significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose either with or without metabolic activation.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance was found to be non-mutagenic under the conditions of this test.