Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.