2,6-di-tert-butyl-p-cresol

Genetic toxicity: in vitro

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 for cross-reference:

reference to same study

Data source

Reference

Reference 1

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 2

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

Test material information

Constituent 1

Reference substance name:

2,6-di-tert-butyl-p-cresol

EC Number:

204-881-4

EC Name:

2,6-di-tert-butyl-p-cresol

Cas Number:

128-37-0

Molecular formula:

C15H24O

IUPAC Name:

2,6-di-tert-butyl-4-methylphenol

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:

S. typhimurium, 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: other: Salmonella typhimurium tester strains: TA98, TA100, TA1535, TA1537, TA1538

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).