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

Genetic toxicity: in vivo

Administrative data

Endpoint:

genetic toxicity in vivo

Remarks:

Type of genotoxicity: other: aneugenic and clastogenic effects (micronuclei formation)

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

Data source

Reference

Reference Type:

publication

Title:

Increased antimutagenic activity of simple substituted phenols mixed with the hindered phenolic antioxidant dibunol

Author:

Paschin, Y., V.; Brakhitova, L., M.; Benthen, T., I.

Year:

1986

Bibliographic source:

Food Chem. Toxicol. 24, 881-883

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method: other: Schmid (1973) Agens & Actions 3: 77

GLP compliance:

not specified

Type of assay:

micronucleus 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: synthesized by Institute of Chemical Physics, Academy of Sciences of the USSR (purity not specified)

Test animals

Species:

mouse

Strain:

other: (CBAxC57BL/6J)F1 hybrid

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals were (CBA x C57BL/6J)F1 hybrid male and female mice, 60-75 days old and weighing 27-30 g

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

sunflower oil

Details on exposure:

see text field materials and methods

Duration of treatment / exposure:

once

Frequency of treatment:

see text field material and methods

Post exposure period:

24 h, 48 h, 72 h, 96 h

Doses / concentrations

Remarks:

Doses / Concentrations:
75 mg/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

Bone marrow was sampled from five control and five mice from each dose group

Control animals:

yes

Positive control(s):

see text field materials and methods

Examinations

Tissues and cell types examined:

Polychromatic erythrocytes from bone marrow

Details of tissue and slide preparation:

see text field materials and methods

Evaluation criteria:

see text field materials and methods

Statistics:

see text field materials and methods

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

see text field results

Any other information on results incl. tables

Incidence of micronuclei in polychromatic erythrocytes was
not statistically different from that in the control at all
time points:
Control: 1.7+/-0.4 (24h); 1.7+/-0.5 (48h); 1.7+/-0.6 (72h);
1.4+/-0.7 (96h)
Treated group: 2.6+/-0.3 (24h); 1.3+/-0.8 (48h); 1.6+/-0.3
(72h); 1.5+/-0.3 (96h)

Applicant's summary and conclusion

Executive summary:

BHT was negative in the in vivo micronucleus assay with mice.