1-methoxypropan-2-ol

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:

1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, equivalent to OECD guideline no. 471.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-methoxypropan-2-ol

EC Number:

203-539-1

EC Name:

1-methoxypropan-2-ol

Cas Number:

107-98-2

Molecular formula:

C4H10O2

IUPAC Name:

1-methoxypropan-2-ol

Details on test material:

- Name of test material (as cited in study report): Dowanol PM
- Physical state: volatile clear liquid

Method

Species / strain

Species / strain / cell type:

other: salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9 rat liver homogenate (aroclor 1254 induced)

Test concentrations with justification for top dose:

2; 10; 50; 250; 1250; 6250 µg/plate

Vehicle / solvent:

none (test material solutions were prepared in distilled water), DMSO for positive controls

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (TA98, TA100, TA1535, TA1537/+S9); 4-nitro-o-phenylenediamine (TA98, TA 1538/-S9); N-methyl-N'-nitrosoguanidine (TA100, TA1535, TA 1537/-S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation

- Incubation period: 48 hours

NUMBER OF REPLICATIONS:
3 replicates per dose / 2 independent repeats

DETERMINATION OF CYTOTOXICITY
- Method: bacterial background lawn evaluation
- no cytotoxcity observed

Evaluation criteria:

Concentrations of the test chemical which are overtly toxic are easily visualized as showing no bacterial growth on the plate (i.e. absence of background lawn). Lower levels of toxicity may be seen as a thin or sparse bacterial lawn, a reduction in the number of revertants, or the appearance of microcolonies (overgrown background lawn). Positive and negative controls were run concurrently with the test chemical, and appropriate responses for these controls are prerequesites for evaluating the response of the bacteria to the test chemical.

A test chemical is considered a bacterial mutagen if both the mean number of revertant colonies observed is at least three times higher than the mea

Statistics:

Means and standard deviations for each treatment were calculated and recorded. An analysis of variance was performed on ecah set of data to give the F-statistic.

Results and discussion

Test results

Species / strain:

other: salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

See attachments for supportive graphs and tables.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Dowanol Propylene glycol methyl ether (Dowanol PM) did not cause mutations in the Ames Salmonela reverse mutation assay both with or without S-9 metabolic activation. Hence, the test material was classified as negative in the Ames test under the experimental conditions used.

Executive summary:

Propylene glycol methyl ether was evaluated in the Salmonella/mammalian-microsome bacterial mutagenicity assay (Ames test) using a plate incorporation assay. The test was conducted using Salmonella typhimurium bacetrial tester strains TA98, TA100, TA1535, TA 1537 and TA1538 at 6 doses in triplicate. The test agent was assayed at 2, 10, 50, 250, 1250, 6250 µg/plate.

The assay was repeated independently . All solvent (negative) control plates and positive control plates gave frequencies of induced revertants within expected ranges. Slight variation in the control were seen for most of the strains with S-9 in both the experiments but was quite normal (not significant).

No evidence of toxicity or insolubility was seen in experiment upto 6250 µg/plate, which is highest dose used.

The test material did not induce a mutagenic response in any of the tester strains in either of the assays as judged by the frequencies of histidine-independent (his+) revertants. Hence, the test material was classified as negative in the Ames under the experimental conditions used.