Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-06-14 to 1999-11-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 2.72 - 2.97 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area : 3000 cm2. No bedding in the cages; wood shavings in the waste trays.
- Diet: Kliba-Labordiet, Klingentalmuehle AG, Kaiseraugst, Switzerland, (about 130 g per animal per day).
- Water: About 250 mL tap water per animal per day.
- Acclimation period: Acclimatization for at least 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod: 12 h/12 h (6.00 a.m.- 6.00 p.m./6.00 p.m.- 6.00 a.m.)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
The test patch (2.5 cm x 2.5 cm) was moistened with 0 .5 mL of the unchanged liquid test substance.
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: Upper third of the back or flanks.
- Type of wrap: Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern and Fixomull(R) stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed at the end of the exposure period with Lutrol(R) = (Polyethylenglycol) and Lutrol(R)/water (1 :1).
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD 404 (1992) and EEC directive 92/69 L383A B.4

- Body weight determination: Shortly before application of the test substance.
- Readings: 1 h, 24 h, 48 h, 72 h, 7 d and 14 d after removal of the patch.
- Mortality: A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays and on public holidays.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritant / corrosive response data:
Erythema and edema extending beyond the area of exposure were observed for all three animals from 24 h onward. All three animals showed eczematoid skin change extending beyond the area of exposure after 7 days. Edema were fully reversible for two of three animals, whereas erythema were not fully reversible within 14 days of observation.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU