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

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Method B14 of directive 92/69/EEC, OECD 471 and according to Japanese MHW/MITI/MAFF guidelines
Principles of method if other than guideline:
Adapted to comply with MITI
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-220-8
EC Name:
-
Cas Number:
5945-33-5
Molecular formula:
C39H34O8P2
IUPAC Name:
4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenyl diphenyl phosphate; 4-{2-[4-({[4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenoxy](phenoxy)phosphoryl}oxy)phenyl]propan-2-yl}phenyl diphenyl phosphate

Method

Target gene:
The chosen stains of Salmonella typhimarium and Escherichia coli were treated with the test material using the Ames plate
incorporation method, both with and without the addition of bacterial metabolic activation system.
The dose range was determined in a preliminary toxicity assay and was 50-5000ug/plate in 2 repeated experiments.
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Including Ecoli WP2uvrA
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9-mix from male Sprague Dawley rats
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate
Vehicle / solvent:
Solvent: Acetone
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 500 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
(> 5000 µg/plate)
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
(> 5000 µg/plate)
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any of the test material, either with or without metabolic activation. A precipitate was observed at and above 500ug/plate, this did not interfere with the scoring of revertant colonies. The test material was considered to be non-mutagenic under the condition of this test.
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 with metabolic activation
negative without metabolic activation

Considered NON-mutagenic to tested strains

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