Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
yes
Amount / concentration applied:
single administration of 0.5g of the test item
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
Immediately and 72 hours after the 3minute and the 1 hour exposure period in the first rabbit and at 1, 24, 48 and 72 hours after the 4-hour exposure period (all rabbits).
Number of animals:
3 males

Results and discussion

Any other information on results incl. tables

No clinical signs, either general or local (at the application sites), were noted in any rabbit.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article when administered to rabbits by dermal route, was "non irritant" for the skin.