Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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 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.