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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP, acceptable, well-documented publication which meets basic scientific principles
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Toxicity studies of butylated hydroxyanisole and butylated hydroxytoluene. I. Genetic and cellular effects
Author:
Williams, G.M.; McQueen, C. A.; Tong, C.
Year:
1990
Bibliographic source:
Food Chem. Toxicol. 28, 793 - 798
Reference Type:
publication
Title:
Lack of genotoxicity of butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT)
Author:
Williams, G., M.; et al.
Year:
1984
Bibliographic source:
Toxicologist, 4, 104

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: in accordance with Ames et al., Mutat. Res. 31, 347-364 (1975)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: purity approximatley 95%, no data about impurities

Method

Target gene:
ames assay: detection of base pair substitutions and frameshift mutations
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 prepared from Aroclor-induced Sprague-Dawley rats
Test concentrations with justification for top dose:
100, 1000, 10000 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: see "materials and methods" field
Details on test system and experimental conditions:
IUCLID4 Type: Ames test, pre-incubation method described by Sugimura and Nagao, Chemical Mutagens 6, 41-60 (1980)
Evaluation criteria:
according to Ames et al. (1975), Mutat. Res., 31, 347-364
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
see text field results
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

NUMBER OF REVERTANTS PER PLATE in negative control and at
100, 1000, 10000 µg/plate (means of triplicate plates;
positive = 3 times solvent control):
- Without metabolic activation:
TA98: 45, 47, 34, 38
TA100: 114, 130, 152, 110
TA1535: 27, 26, 20, 26
TA1537: 5, 7, 7, 5
TA1538: 25, 23, 29, 33

- With metabolic activation:
TA98: 45, 48, 66, 59
TA100: 133, 130, 176, 174
TA1535: 21, 26, 23, 28
TA1537: 4, 6, 6, 10
TA1538: 32, 30, 24, 26

No data about cytotoxicity (but highest concentration 10
mg/plate).
All positive controls valid (with expected responses).

EVALUATION OF RESULTS
- With metabolic activation: negative
- Without metabolic activation: negative

Applicant's summary and conclusion

Executive summary:

BHT was not mutagenic in any of the five Salmonella typhimurium tester strains ( TA98, TA100, TA1535, TA1537, TA1538) either with or without S9 at concentrations up to 10000 µg/plate (Williams 1990).