6-tert-butyl-m-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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study, carried out by Research Institute for Animal Science in Biochemistry and Toxicology (Japan)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Principles of method if other than guideline:

OECD Guide-line 471 and 472

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

6-tert-butyl-m-cresol

EC Number:

201-842-3

EC Name:

6-tert-butyl-m-cresol

Cas Number:

88-60-8

Molecular formula:

C11H16O

IUPAC Name:

2-tert-butyl-5-methylphenol

Details on test material:

Produced by Sumitomo Chemical, Lot No.71012, Purity:99.23%

Method

Target gene:

no data

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2uvrA

Details on mammalian cell type (if applicable):

no data

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

-S9 mix: 0, 6.25, 12.5, 25, 50, 100, 200 µg/plate
+S9 mix: 0, 6.25, 12.5, 25, 50, 100, 200 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: -S9 mix; 2-(2-Furyl)-3-(5-nitro-2- furyl) acrylamide(TA100, TA98, WP2), Sodium azid (TA1535) and 9-Aminoacridine(TA1537) +S9 mix; 2-Aminoanthracene(all strains)

Remarks:

no

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: Toxicity was observed at 100 and 200 µg/plate in TA strains with and without S9 mix, and 100 µg/plate without S9 mix and 200 µg/plate with S9 mix in E. coli WP2 uvrA

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2uvrA

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

*Genotoxic effects:            +   ?    -
With metabolic activation:    [ ] [ ] [ X ]
Without metabolic activation: [ ] [ ] [ X ]

Applicant's summary and conclusion

Conclusions:

Bacteria gene mutation is negative with and without metabolic activation.

Executive summary:

method: bacterial reverse mutation assay with Salmonella typhimurium TA100, TA1535, TA98, TA1537, Echerichia coli

according OECD TG 471/472

result: negative, with and without metabolic activation

reference: MHW, Japan (1999)