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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Batch number: GK 100 B

Test animals

Species:
rat
Strain:
other: CD strain (remote Sprague-Dawley origin)
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
The acute percutaneous toxicity of BIT was investigated in a group of five male and five female CD rats. The test material was applied to the closely-clipped dorsum of each animal at a dosage of 2000 mg/kg bodyweight and was covered by an occlusive dressing for 24 hours. Mortality, systemic and local signs of reaction to treatment were recorded during a subsequent 14-day period of observation. The animals were killed on the following day and subjected to necropsy.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no death and there were no systemic signs of reaction to treatment.
Clinical signs:
Local signs comprised very slight or well-defined erythema, slight exfoliation and eschar formation.
Body weight:
The animals achieved expected bodyweight gains
Gross pathology:
necropsy revealed no significant macroscopic lesion.

Any other information on results incl. tables

Under the conditions of this study, the acute percutaneous median lethal  dosage (LD50) of the test material was greater than 2000 mg/kg. 

Applicant's summary and conclusion

Conclusions:
There was no death and there were no systemic signs of reaction to treatment.

Local signs comprised very slight or well-defined erythema, slight exfoliation and eschar formation.
The animals achieved expected bodyweight gains and necropsy revealed no significant macroscopic lesion.
Accordingly, BIT was assigned to the class ‘low percutaneous toxicity’.
Executive summary:

A study was conducted to determine the acute dermal toxicity of the substance in rats according to OECD Guideline 402. The test substance was applied to the closely-clipped dorsum of a group of five male and five female rats at a dosage of 2000 mg/kg  bodyweight and was covered by an occlusive dressing for 24 hours. Mortality, systemic and local signs of reaction to treatment were recorded during a subsequent 14-day period of observation. The animals were sacrificed on Day 15 and subjected to necropsy. There was no mortality and no systemic signs of reaction to treatment. Local signs comprised of very slight or well-defined erythema, slight exfoliation and eschar formation. The animals achieved expected bodyweight gains and necropsy revealed no significant macroscopic lesion. Under the study conditions, the acute dermal LD50 of the substance in rats was determined to be greater than 2000 mg/kg bw (Rees, 1994).