Registration Dossier

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:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Composition of test material, percentage of components: 45.5 % active compound in water

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: RCCHan:WIST
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: approximately 9-13 weeks
- Diet and water: ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Type of coverage:
other: semiocclusive, but predominantly covered with air-tight plaster
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TREATMENT
The liquid test substance was applied pure. Dosing with 2000 mg/kg bw was based on the active ingredient content of 45.5% in water, the body weight of the animals and the surface area on which the test substance was applied.
Treatment area: 30 cm²
TEST SITE
One day before the start of the treatment the back and flanks of the rats were shorn (approximately 10% of the body surface area). For each dose and animal the required amount of the pure liquid test substance was calculated on the base of the body weight at time of dosing. This amount was weighed and applied as uniformly and thinly as possible to the test area, covered with a gauze-layer (6.0 cm x 5.0 cm = 30.0 cm²) of a "Cutiplast steril" coated with air-tight "Leukoflex". The gauze strip was placed on the rat's back and secured with a "Lomir biomedical Inc rat jacket", which was connected with a safety pin to the stretch tape to ensure that the animals could not ingest the test substance.

REMOVAL OF TEST SUBSTANCE
After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry.
Duration of exposure:
24 hours
Doses:
Limit dose of 2000 mg/kg bw ; according to 18.8 to 19.6 mg active ingredient/cm² for male rats and 16.3 to 17.1 mg active ingredient/cm² for female rats.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: at least 14 days
- Frequency of observations: once daily
- Frequency of weight determination: once weekly
- Necropsy of survivors performed: yes
Statistics:
none; limit dose test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: no mortalities, clinical signs, toxicological effects on weight development and gross pathological findings
Mortality:
No mortalities occured.
Clinical signs:
none
Body weight:
There were no toxicologically significant effects on body weight or body weight development in males and females.
Gross pathology:
The necropsies performed at the end of the study revealed no particular findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Executive summary:

In an acute dermal toxicity study on rats performed according to OECD TG 402 2000 mg/kg bw of the substance were applied to the skin of 5 male and 5 female rats for 24 hours. The test substance was tolerated by the animals without mortalities, clinical signs, toxicological effects on weight development and gross pathological findings. The resulting dermal LD50 was determined with > 2000 mg/kg bw.