Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
A group of male white rats was treated with a single dose of 5000 mg/kg b.w. by dermal route. Gauze pads with the test substance were applied for 4 hours on the skin of the back of animals and the treated skin areas were not washed after the exposure..
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: shaved skin of the back of animals
- Type of wrap if used: gauze pad

REMOVAL OF TEST SUBSTANCE
The treated skin areas were not washed after the exposure.

Duration of exposure:
4 h
Doses:
5000 mg/kg
No. of animals per sex per dose:
n.a.
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The LD50 (rat, dermal) was found to be > 5000 mg/kg b.w
Executive summary:

The dermal acute toxicity study was performed according to an internal method: a group of male white rats was treated with a single dose of 5000 mg/kg b.w. by dermal route. Gauze pads with the test substance were applied for 4 hours on the skin of the back of animals and the treated skin areas were not washed after the exposure.

The acute dermal LD50 of the substance in rats was found to be more than 5000 mg/kg b.w.