Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Referred in a recognized source of peer reviewed scientific data on chemicals

Data source

Reference
Reference Type:
publication
Title:
A re-examination of the possible teratogenic effects of butylated hydroxytoluene (BHT) and ist effect on the reproductive capacity of the mouse.
Author:
Johnson
Year:
1965
Bibliographic source:
Food Cosmet Toxicol. 1965 Sep; 3(3): 371-375.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Reproductive Toxicity (Generation) Study
Principles of method if other than guideline:
Reproductive Toxicity (Generation) Study
GLP compliance:
not specified

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:
Phenol, 2,6-bis(1,1-dimethylethyl)-4-methyl-
Details on test material:
data for components

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Study observed:

At 0.5%: no anophthalmia was observed in F1 generation; some effects on reproductive function

The study authors concluded that under the conditions of the experiment and in the strains of mice employed, BHT was not a teratogenic agent.

 

NOAEL (developmental) =714 mg/kg bw/day

Applicant's summary and conclusion

Conclusions:
Component data