1-propoxypropan-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:

Dec 1995 to Aug 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study according to OECD guideline 471.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Test guideline 4

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Test guideline 5

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-propoxypropan-2-ol

EC Number:

216-372-4

EC Name:

1-propoxypropan-2-ol

Cas Number:

1569-01-3

Molecular formula:

C6H14O2

IUPAC Name:

1-propoxypropan-2-ol

Details on test material:

- Name of test material (as cited in study report): Propylene glycol n-propyl ether (DOWANOL PnP)
- Physical state: clear colorless liquid
- Lot/batch No.: 950720

Method

Target gene:

Induction of reverse mutations at the histidine locus of S. typhimurium and the tryptophan locus in E. coli.

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 Mix

Test concentrations with justification for top dose:

0, 100, 333, 1000, 3330 and 5000 µg/plate

Vehicle / solvent:

Water

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, WP2uvrA/+S9); 2-nitrofluorene (TA98/-S9); sodium azide (TA100, TA1535/-S9); ICR-191 (TA1537/-S9); 4-nitroquinoline-N-oxide (WP2uvrA/-S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Incubation period: 48 hours

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

DETERMINATION OF CYTOTOXICITY
- Method: bacterial background lawn evaluation (decrease in number of revertant colonies
- no cytotoxicity observed

Evaluation criteria:

For a test article to be considered positive, it had to produce at least a 3-fold increase in the mean revertants per plate of at least one tester strain over the mean revertants per plate of the appropriate vehicle control. This 3-fold or greater increase in the mean number of revertants per plate had to be observed at more than one dose and had to be accompanied by a dose response to increasing concentrations of the test article. In addition, the observed dose-responsive increase had to be shown to be reproducible. An observed response which did not meet all three of the above criteria (magnitude, dose-responsiveness, reproducibility) was not evaluated as positive.

Statistics:

None

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

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'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The results of the Salmonella - Escherichia coli/Mammalian-Microsome Reverse Mutation Assay, Preincubation Method, with a Confirmatory Assay, indicate that, under the conditions of this study, in both an initial and confirmatory assay, test article, Propylene glycol n-propyl ether, did not cause a positive increase in the number of revertants per plate of any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor-induced liver (S9).

Executive summary:

Propylene glycol n-propyl ether (DOWANOL PnP), was evaluated in the Salmonella-Escherichia coli/mammalian-microsome bacterial mutagenicity assay using a pre-incubation modification of the standard assay. The test was conducted in the presence and absence of an externally supplied metabolic activation system (S-9) using Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537 and Escherichia coli tester strain WP2ucrA. The concentrations of the test material assay ranged from 100 to 5000 µg/plate. The test material did not induce a positive increase in the number of revertant colonies in any of the tester strains either in the presence or absence of the external metabolic activation system. The results were confirmed in an independent assay. Hence, propylene glycol n-propyl ether (DOWANOL PnP) was classified as negative in this bacterial mutagenicity test under experimental conditions used.