Registration Dossier

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:
other: No OECD guideline available at the study performance date.

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List V
Author:
Smyth HF
Year:
1954
Bibliographic source:
Archives of Industrial Hygiene and Occupational Medicine vol 10, pp 61-68

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
method akin to the one-day cuff method of Draize 1944 (Methods of study for irritation and toxicity of substances applied topically to the skin and mucous membranes, Journal Pharmacol. Exp. Therap. 82:377).
GLP compliance:
no
Test type:
standard acute method

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
body weight: 2.5–3.5 kg

Administration / exposure

Details on dermal exposure:
- fur removed from the entire trunk by clipping
- dose retained beneath an impervious plastic film
- immobilisation of the animals during exposure
- observation for 14 days after the end of exposure
Duration of exposure:
24 hours
Doses:
no data
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
no data
Statistics:
LD50: method of Thompson and Weil

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50, dermal, rabbit was > 20mL per kg body weight when applied for 24 hours to the intact skin of rabbits.
Executive summary:

The test substance was applied to the intact skin of 4 male rabbits per group for 24 hours. The animals were observed for mortalities for further 14 days. The LD50, calculated according to the method of Thompson and Weil, was > 20 mL per kg body weight which is equal to 18840 mg/kg bw.