Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
according to guideline

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 10% of the total body surface
-warap: elastic adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water and dried with disposable paper towels;
- Time after start of exposure: 24h;


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 ml
-concentration: 0.25 g/ml
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): 8 ml
- Concentration (if solution): 0.25 g/ml
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
according to guideline

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No death occured during the study.
Clinical signs:
All female animals and two male animals showed a slight erythema after removal of the dressing on day 2. The erythema persisted as slight until test day 4 to 6
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age
Gross pathology:
No macroscopic findings were observed at necropsy

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
substance not subject of classification and labeling