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Diss Factsheets

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: Test was conducted according to EU Method B.13/14 and compliant with GLP.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Phenol, 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2- ethylhexyl)oxy)-2-hydroxypropoxy)-
IUPAC Name:
Phenol, 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2- ethylhexyl)oxy)-2-hydroxypropoxy)-
Constituent 2
Chemical structure
Reference substance name:
2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol
EC Number:
419-740-4
EC Name:
2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol
Cas Number:
137658-79-8
Molecular formula:
C36H45N3O4
IUPAC Name:
2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-{3-[(2-ethylhexyl)oxy]-2-hydroxypropoxy}phenol

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella thyphimurium Souches TA 1535, TA 1537, TA 98, TA 100 et Escherichia coli WP2 et WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
S 9 mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 33.3 … 5000 µg/plate
Concentration range in the main test (without metabolic activation): 33.3 … 5000 µg/plate
Vehicle / solvent:
Solvent: Acetone

Results and discussion

Test results
Species / strain:
other: as specified above
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Remarks on result:
other: other: preliminary test
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

The substnace showed no evidence of mutagenic activity when tested in this bacterial system with and without metabolic activation.
Cytotoxic concentration: Not cytotoxic up to 5000 µg/plate