Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Section 1500.41 - Hazardous Substances and Articles, Administration and Envforcement Regulations, U.S. Federal Register, 38(187), p 27019, 27 Sept 1973.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
Principles of method if other than guideline:
Test material applied to clipped back of rabbits, covered in place for 24 hr and observed for toxicity and mortality for 14 d.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
other: albino rabbits
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hr
Doses:
single dose of 2.0 gm/kg bw
No. of animals per sex per dose:
6 rabbits total
Control animals:
no

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD0
Effect level:
> 2 other: gm/kg
Based on:
test mat.
Mortality:
no rabbits died on test

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
EBTBP was not acutely toxic when administered dermally to rabbits.
Executive summary:

EBTBP was administered as a single dose of 2,000 mg/kg to the clipped skin of 6 albino rabbits. The skin of three of the animals was abraded prior to treatment. The test site was wrapped with an impervious material. The wrapping was removed at 24 hr, any excess test article removed, and the animals observed for 14 days. No animals died during the test. The dermal LD50 was > 2,000 mg/