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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
In an Ames test , tert-butyl-4-methoxyphenol, in dimethyl sulfoxide from doses 1-1000 ug/plate was not mutagenic in Salmonella typhimurium strains TA97, TA100,TA102 and TA104 with and without addition of S9 liver fractions from Aroclor induced rats.
Link to relevant study records
Reference
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:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from ACTOR database
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 97
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium, other: TA104
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
RAT, LIVER, S-9, AROCLOR
Test concentrations with justification for top dose:
1-1000 UG/PLATE
Vehicle / solvent:
DMSO
Details on test system and experimental conditions:
Test System : AMES SALMONELLA TYPHIMURIUM
Method : STANDARD PLATE
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium, other: TA104
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

In an Ames test , tert-butyl-4-methoxyphenol, in dimethyl sulfoxide from doses 1-1000 ug/plate was not mutagenic in Salmonella typhimurium strains TA97, TA100,TA102 and TA104 with and without addition of S9 liver fractions from Aroclor induced rats.
Executive summary:

In an Ames test , tert-butyl-4-methoxyphenol, in dimethyl sulfoxide from doses 1-1000 ug/plate was not mutagenic in Salmonella typhimurium strains TA97, TA100,TA102 and TA104 with and without addition of S9 liver fractions from Aroclor induced rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Sister chromatid exchange assay in mammalian cells (Rodent - hamster Fibroblast) for tert-butyl-4-methoxyphenol examined at the dose concentration 100 umol/L.

Justification for classification or non-classification

Studies suggest that the tert-butyl-4-methoxyphenol will not be classified in genetic toxicity category as per the C & L criteria set by EU.