Registration Dossier

Diss Factsheets

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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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
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 or test system and environmental conditions:
according to Guideline

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: backs
- % coverage: 10
- Type of wrap if used: gauze


REMOVAL OF TEST SUBSTANCE
- Washing: flushed with lukewarm tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 ml /kg
- Concentration (if solution): 0,25 g/ml
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
according to Guideline

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no death occured during the study
Clinical signs:
At removal of the application patch the lokal skin reactions were not assessable in all animals due to a red staining produced by the test item. The assessment was prevented up to test day 6 in all males and up to test day 5 in all females. When assessable, no local erythema was observed in all animals. However, slight crusts were noted in one animal at test day 10 and in five animals on test days 5,7 and 8 which persisted up to test day 9,10, 11 and until the end of observation period, respectively. Additionally, slight scaling was noted in six animals on test days 4,7 and 8 persisting up to test days 7,9 and 10, respectively.
Body weight:
the body weight was within the range of commonly recorded.

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;