Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Lot No.: T 75492/ST 1414/90, Part 1
- Physical state: solid, light beige; after heating at about 50°C: liquid, yellow
- Date of manufacturing: 1990-10-10
- Storage stability: at about 8°C

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, D
- Weight at study initiation: 3.44 kg (male), 3.17-3.51 kg (females)
- Housing: single in stainless steel cages with wire mesh walk floors
- Diet: KLIBA 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, CH; 130 g/ day
- Water: tap water; 250 mL/ day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping of the fur
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
Application of 0.5 ml of the test substance (cooled down to body temperature) to the test patch (2.5 cm x 2.5 cm)
Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3
Details on study design:
Clipping of the fur: at least 15 hours before the beginning of the study.
Application site: upper third of the back or flanks
Removal of the test substance: at the end of the exposure period with Lutrol and Lutrol/water (1:1)
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h, 72 h, 8 d and 15 d after beginning of application; scoring according to the OECD/Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
1.2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: scaling observed on 1/3 animals at the 15d reading; see table below for details
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: scaling observed at the end of the observation period
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion