Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17. Apr 1974 - 02. May 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
BASF-Test. The study was performed according to: Noakes D.N. and Sanderson D.M., A Method for Determining the Dermal Toxicity of Pesticides. Brit. Journ. Ind. Med. 26, 59, 1969. 5 animals were treated for 4 or 24 h using occlusive conditions. An application site of 50 cm² was covered with the test substance and the trunk of the rat was encircled with a strip of plaster (2 layers). After the exposure time the skin was washed with detergent and water. The animals were observed 8 days and skin changes were recorded daily.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: WIGA- Weight at study initiation: male: 144g (mean); female: 134g (mean)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE- Area of exposure: 50 cm²REMOVAL OF TEST SUBSTANCE- Washing: After the exposure time the skin was washed with detergent and water.TEST MATERIAL- Concentration (if solution): 100%- Constant concentration used: yes
Doses:
5 ml/kg (equivalent to 5g/kg)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days - Frequency of observations and weighing: Animals were weighted prior to exposure and symptoms were recorded daily.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: see overall remarks.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality was observed.
Clinical signs:
No abnormal clinical signs could be observed. All animals obtained local staining (brown) from residual substance.
Body weight:
Data for body weight at necropsy was not recorded.
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

Mortality:

 Dose:  sex:  1h  24h  48h  7 days  14 days
 5  ml/kg  male   0/5   0/5   0/5   0/5   0/5
 5 ml/kg  female   0/5   0/5   0/5   0/5   0/5

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The substance was tested for acute toxicity dermal in rats following Noakes D.N. and Sanderson D.M., A Method for Determining the Dermal Toxicity of Pesticides. Brit. Journ. Ind. Med. 26, 59, 1969. Under the experimental conditions the substance has LD50 > 1000 mg/kg bw /day (> 5000 mg/kg bw/day for the mixture preparation).
Executive summary:

The substance was tested for acute toxicity dermal in rats following Noakes D.N. and Sanderson D.M., A Method for Determining the Dermal Toxicity of Pesticides Brit. Journ. Ind. Med. 26, 59, 1969.One single dose of 5000 mg/kg bw /day was tested on 5 rats (male and female) by occlusive application. Under the experimental conditions the substance has LD50 > 1000 mg/kg bw /day (> 5000 mg/kg bw/day for the mixture preparation).