Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS et al.
Year:
1962
Bibliographic source:
Am Ind Hyg Assoc J 23: 95-107

Materials and methods

Principles of method if other than guideline:
Method: other: Smyth/Carpenter
GLP compliance:
no
Remarks:
prior to GLP
Test type:
standard acute method
Limit test:
no

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult (based on body weight)
- Weight at study initiation: 2.5 - 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
Penetration of rabbit skin was estimated by the one-day cuff method of Draize and associates. The fur was closely clipped over the entire trunk, and the dose retained beneath an impervious plastic film.
Duration of exposure:
24 hours
Doses:
up to 20 mL/kg bw
No. of animals per sex per dose:
4 animals
Control animals:
not specified
Details on study design:
After 24 hours contact the film was removed. Mortality was considered complete after 14 additional days.
- Duration of observation period following administration: 14 days
Statistics:
The most probable LD50 was estimated by the methods of Thompson (1947) and Weil (1952).

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 000 mg/kg bw
Remarks on result:
other: reported as 1.00 mL/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 0.68 - <= 1.48 mL/kg bw
Mortality:
Death occurred within 14 days, no detailed information provided.
Clinical signs:
No information provided
Body weight:
No information provided
Gross pathology:
No information provided

Any other information on results incl. tables

24 h exposure time, deaths within 14 days. Limits of +/- 1.96 standard deviation using the method of Thompson: 680 - 1480 mg/kg bw. Original LD50 given as 1.0 mL/kg bw.

Applicant's summary and conclusion