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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according 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): Golpanol PAP / 2-Propyn-1-ol, compd. with methyloxirane
- Physical state: liquid
- Analytical purity: 53.4 %
- Impurities (identity and concentrations): 33 % water, 55 ppm Propylene oxide, others: Propylene glycol, Propargyl alcohol,
- Stability under test conditions: proven by reanalysis
- Stability in of test substance in aqua dest. (vehicle) was verified analytically
- Storage condition of test material: Room temperature (protected from light, N2 conditions)

Method

Target gene:
HIS
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix
Test concentrations with justification for top dose:
20; 100; 500; 2500 and 5000 µg/plate
Vehicle / solvent:
purified water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: see: Any other information on materials and methods
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate ( control)
- dose-response relationship
- reproducibility of the results.
Statistics:
not applicable

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
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS

- Precipitation: no precipitates found


ADDITIONAL INFORMATION ON CYTOTOXICITY: No bacteriotoxic effect (reduced his' background growth, decrease in the number of his+ revertants) was observed.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Neither the the preincubation test nor the standard plate test with or without S-9 mix increased the number of his+ revertants in any of the tested bacteria strains.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

Neither the the preincubation test nor the standard plate test with or without S-9 mix increased the number of his+ revertants in any of the tested bacteria strains.