1-phenoxypropan-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:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted in compliance with GLP regulations

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-phenoxypropan-2-ol

EC Number:

212-222-7

EC Name:

1-phenoxypropan-2-ol

Cas Number:

770-35-4

Molecular formula:

C9H12O2

IUPAC Name:

1-phenoxypropan-2-ol

Constituent 2

Reference substance name:

1-phenylpropan-2-ol

EC Number:

211-821-0

EC Name:

1-phenylpropan-2-ol

Cas Number:

698-87-3

IUPAC Name:

1-phenylpropan-2-ol

Details on test material:

- Name of test material (as cited in study report): Protectol PP (#96/344)
- Physical state: liquid / colorless
- Analytical purity: mixture (86/14.9%)
- Composition of test material, percentage of components: 84.8% 1-phenoxy-propan-2-ol and 14.7% 2-phenoxy-propan-1-ol
- Stability under test conditions: verified by reanalysis
- Storage condition of test material: at room temperature

Method

Target gene:

not applicable

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537

Details on mammalian cell type (if applicable):

- Type and identity of media: no data
- Properly maintained: no data
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix (Arochlor induced rat liver)

Test concentrations with justification for top dose:

standard plate test : 0, 20, 100, 500, 2500 & 5000 μg/plate +/- S9 mix from Arochlor-induced rat liver
preincubation test : 0, 20, 100, 500, 2500 & 5000 μg/plate +/- S9 up to 5000 micrograms per plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: stability of the test substance in DMSO and in water was assured analytically

Controls

Untreated negative controls:

yes

Remarks:

sterility control

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene (2-AA), N-methyl-N’-nitro-N-nitroso guanidine (MNNG), 4-nitro-o-phenylenediamine (NOPD), 9-amino acridine (AAC), N-ethyl-N’-nitro-N-nitroso guanidine (ENNG)

Details on test system and experimental conditions:

FIRST EXPERIMENT - METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: not applicable
- Exposure duration: 48 - 72 hours
- Expression time (cells in growth medium): 48 - 72 hours

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency

SECOND EXPERIMENT - METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 - 72 hours
- Expression time (cells in growth medium): 48 - 72 hours

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiencyes

Evaluation criteria:

In general, a substance to be characterized as positive in the bacterial tests has to fulfill the following requirements: doubling of the spontaneous mutation rate (control), dose-response relationship and reproducibility of the results.

Statistics:

standard statistical methods

Results and discussion

Test results

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:

not specified

Positive controls validity:

valid

Additional information on results:

no data

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Solubility in DMSO and stability of test substance in DMSO and water was analytically checked. No precipitation of test substance was observed.  No increase of revertants (his+ revertants) was seen with test substance with any of the tester strains, neither with nor without S9, neither in the standard plate test nor in the preincubation test.

The results of negative and positive controls indicated that the tests were valid. Occasionally a slight decrease in the number of his+ revertants was observed, indicating weak bacterial toxicity.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Under the conditions of the study, Propylene glycol phenyl ether was not mutagenic in the Ames test.

Executive summary:

In this AMES test conducted according to the OECD TG 471 and TG 472 and EU Method B.13/14, Salmonella typhimurium strains (TA98, TA 100, TA 1535 and TA 1537) were exposed to Propylene glycol phenyl ether following the standard plate test and the preincubation test in the presence and absence of S9 mix from Arochlor-induced rat liver) at concentrations ranging from 20, 100, 500, 2500 and 5000 μg/plate. Untreated controls were also evaluated in the study. Also, 2-Aminoanthracene (2-AA), N-methyl-N’-nitro-N-nitroso guanidine (MNNG), 4-nitro-o-phenylenediamine (NOPD), 9-amino acridine (AAC), N-ethyl-N’-nitro-N-nitroso guanidine (ENNG) were used as positive controls.

The results indicated that there was no increase in number of his+ and trp+ revertants in either standard plate or preincubation test. Hence, under the conditions of the study, Propylene glycol phenyl ether was not considered mutagenic in the Ames test.