Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Dec 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- time-points of evaluation were 20, 44 and 68 hours instead of 24, 48 and 72 hours after end of exposure
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
other: the untreated skin served as control
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
2 males and 2 females

Results and discussion

Any other information on results incl. tables

The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 20, 44 and 68 hours after the end of administration were 0.

Applicant's summary and conclusion

Executive summary:

A single dermal administration of the test substance (0.5 g applied as a paste) for 4 hours to male and female rabbits was tolerated without any local irritations. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 20, 44 and 68 hours after the end of administration were 0.