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: see 'Remark'
Remarks:
Acceptable, study containing basic data which suggests that basic scientific principles have been met. This is sufficient to judge the results reliable as a contribution to the understanding of the toxicity of this substance. A number of observations missing but not considered critical bearing in mind the very low toxicity observed.

Data source

Reference
Reference Type:
publication
Title:
Range finding toxicity data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel BS
Year:
1962
Bibliographic source:
Am Ind Hyg Ass J, 23, 95

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Similar to one day cuff method of Draize (J Pharmac Exp Therap, 82, 377, 1944)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

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:
TEST ANIMALS
- Weight at study initiation: 2.5-3.5kg
- Other: albino rabbits used.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Fur removed from entire trunk area by clipping
- % coverage:
- Type of wrap if used: impervious plastic film

OTHER
- Animals immobilised during exposure period.
Duration of exposure:
24 hours
Doses:
not specified
No. of animals per sex per dose:
4
Control animals:
other: no but a large number of other substances also tested which acted as reference materials.
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Mortality:
No data given on doses used or mortalities at respective dose levels. No information on times of death, symptoms or necropsy information.
Clinical signs:
No information on symptoms
Gross pathology:
No information on necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In an acute dermal toxicity in rabbits in which key basic details were reported, an LD50 was not seen at the maximum tested dose of 20g/kg with exposure was under occluded conditions. The substance can be considered as not acutely toxic by the dermal route.

Synopsis

LD50>20g/kg