Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 Apr - 19 May 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit und Soziales, Hamburg, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 4 months
- Weight at study initiation: 2.1-2.5 kg
- Housing: during the acclimatisation period and after the 4-hour period in restrainers (allowed free movement of the head but prevented a complete body turn), the animals were kept singly in cages (425 mm x 600 mm x 380 mm)
- Diet: ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, Soest, Germany); available ad libitum before and after the exposure period
- Water: drinking water, ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
-according to guideline

IN-LIFE DATES: From: 28 Apr 2003 To: 19 May 2003

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 h
Observation period:
up to 5 days
Reading time points: 1, 24, 48 and 72 h, 4 and 5 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with a gauze patch, which was held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- no residual test substance had to be removed

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
Erythema of grade 1 was observed in one animal at the reading time points 24, 48 and 72 h and 4 days after patch removal. No further signs of skin irritation were noted in any of the animals.
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of this skin irritation study in the rabbit, the test item did not cause any irritant effect to the skin.