Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Purity : 96.7%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
App. 10% of the body surface area was clipped 24 hours prior to the dermal application.
Duration of exposure:
24 hrs exposure period and observation for a period of 14 days.
Doses:
2000 mg/kg b.w. by single dermal application of 0.41 to0.57 ml of undiluted test substance
No. of animals per sex per dose:
Two groups of rats, each comprising of 5 males and 5 females.
Control animals:
yes, concurrent vehicle
Details on study design:
The substance was held in contact with the skin throughout the 24 hours exposure period using a porous gauze dressing and a non-irritating tape

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No clinical sign was observed.
Gross pathology:
Lesion that were observed in the rats sacrificed at termination belonging to the control group were considered to be spontaneous or incidental findings.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute dermal median lethal dose LD50 (cut off value) of d-trans Allethrin 75/25 in Wistar rats was found to be greater than 2000 mg/kg b.w.