Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From April 30th to May 21st, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24th, 1987
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
July 31st, 1992
GLP compliance:
yes (incl. certificate)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Stable in a 1:1 mixture of PEG/water for 48 hours

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: other: bidistilled water:PEG 400 = 1:1
Details on dermal exposure:
Clipped area on the back of animals corresponding to ca. 10 % of the total body surface.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male rats, 5 female rats
Control animals:
no
Details on study design:
Observations up to day 15.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred.
Clinical signs:
There were no clinical signs of sistemic toxicity.
Body weight:
The body weight gain of the animals was within the normal range for rats of this strain and age. The slight loss of body weight in two female animals (nos. 7 and 10) during the first observation week was considered to be a consequence of the semi-occlusive dressing. Commonly female animals prove to be more sensitive in relation to the effects on body weight caused by semi-occlusive dressing than male.
Gross pathology:
No macroscopic findings were noted at necropsy.
Other findings:
After removal of the dressing on test day 2, a blue coloration of the skin was observed at the application site of all animals. The staining persisted until test day 7.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified within the CLP Regulation (EC 1272/2008).
Conclusions:
LD50 > 2000 mg/kg