Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MBDA

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG
- Weight at study initiation: 3.05, 2.87, and 2.91kg
- Housing: 1 animal per cage, stainless steel cages with wire mesh walk floors; floor area: 40 cm x 51 cm, no bedding in the cages
- Diet: 130 g per day Kliba 341, 4 MM (Firma Klingenmuehle AG, CH-4303 Kaiseraugst, Switzerland)
- Water: 250 mL per day tap water
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air: room were fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 mL to the test patch (2.5 cm x 2.5 cm)
Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: upper third of the back of flanks, 2.5 cm x 2.5 cm
- Type of wrap if used: test patch was secured in position with porous dressing (four layers of absorbent gauze + porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM:
- Skin irritation/corrosion scoring according to 83/467/EEC criteria of July 29th, 1983
- Readings 30-60 minutes after removal of the test patches and 24h, 48h, 72h, 8d, and 15d after beginning of application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
2.7
Max. score:
4
Reversibility:
not 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: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
In animal 1 and 3 scaling was observed at day 8, for animal 1 also at day 15.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the substance is considered to be irritating to the skin.
Executive summary:

The potential to cause acute dermal irritation or corrosion was assessed, in a OECD 404 guideline study, by a single topical application of an amount of 0.5 mL of the test substance for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semiocclusive dressing. After removal of the patch, the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch and approximately 24, 48, 72 hours, and 8, 15 days after removal. The mean score (24 to 72 hours) for erythema was calculated to be 2.7, 1.3 and 3.0 for animal 1, 2 and 3 respectively. The mean score for edema was calculated to be 2.0, 0 and 1.3 for animal 1, 2 and 3 respectively. It was concluded that the test substance was irritating to the skin.