Registration Dossier

Toxicological information

Acute Toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: publication which does not give sufficient experimental details

Data source

Reference
Reference Type:
publication
Title:
Lung toxicity and tumor promotion by hydroxylated derivatives of 2,6-di-tert-Butyl-4methylphenol (BHT) and 2-tert-Butyl-4-methyl-6-iso-propylphenol: Correlation with Quinone methide reactivity
Author:
Kupfer, R.; Dwyer-Nield, L., D.; Malkinson, A., M.; Thompson, J., A.
Year:
2002
Bibliographic source:
Chem. Res. Toxicol., 15, 1106-1112

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
other: toxicity study, single injection (i.p.) of BHT
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
corn oil
Doses:
0, 100, 150, 200 mg/kg
and 200 mg/kg
No. of animals per sex per dose:
5 per group
Control animals:
yes

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: maximum tolerated dose, single i.p. injection
Effect level:
200 mg/kg bw

Any other information on results incl. tables

100 mg/kg BHT had no significant effect on the lung weight: body weight ratio, but 200 mg/kg was effective

Histologic analysis of lungs: BHT produced compensatory type 2 cell hyperplasia and macrophage infiltration

Applicant's summary and conclusion

Executive summary:

MTD (i.p.): 200 mg/kg bw (Kupfer, 2002).