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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:
3 February to 31 March 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with internationally recognised guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): 3,9-bis(2,6-bis(1,1-dimethylethyl)-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- Physical state: White crystalline powder
- Purity: >99%
- Lot/batch No.: P101
- Expiration date of the lot/batch: not reported
- Storage condition of test material: not reported

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Details on mammalian cell lines (if applicable):
- Type and identity of media: Oxoid nutirent broth #2
- Properly maintained: yes, cultures were freshly prepared from frozen stock culture
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 fraction, obtained from rats treated with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 78 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 78 ... 5000 µg/plate
Vehicle:
Solvent: DMSO
Controlsopen allclose all
Solvent controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
9-aminoacridine
Solvent controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
Solvent controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Details on test system and conditions:
METHOD OF APPLICATION: preincubation

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

Evaluation criteria:
A compound is regarded as mutagenic when it induces the revertant colonies dose-dependently and the numbers of revertants are more than
twice of that of the control.
Statistics:
Statistical method was not used for the data analysis.

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
Cytotoxicity:
no
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
None reported

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The test substance did not induce revertant colonies in S. typhimurium TA98, TA100, TA1535 and TA1537, and E. coliWP2uvrA with or without metabolic activation. Based on the above results, the present test substance was assessed to be negative.