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Toxicological information

Genetic toxicity: in vitro

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
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

Constituent 1
Chemical structure
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.

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