Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Body weights were not determined at the end of the study.
Principles of method if other than guideline:
Noakes and Sanderson, A method for determining the dermal toxicity of pesticides, Brit. Journ. Ind. Med. 26, 59 (1969)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid

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: mean 138 g (male), 137 g (female)

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back of animals, 50cm2

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.6 - 0.8 g
- Concentration: 50%
- Constant volume or concentration used: yes
Duration of exposure:
one application
Doses:
2500 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No adverse effects were observed.
Mortality:
no mortalities
Clinical signs:
no abnormalities found
Body weight:
Body weights were only determined at the beginning of the study.
Gross pathology:
no abnormalities found
Other findings:
yellow substance residues on the skin, observed until day 5 post application.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met