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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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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

Constituent 1
Chemical structure
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.