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:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: White russian (albino)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG, Bielefeld, Germany
- Age at study initiation: 11 months
- Weight at study initiation: males 2.30-2.40 g
- Housing: individually
- Diet: approx. 120 g/day and animal
- Water: ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18.09.1989 To: 20.09.1989

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: control site at the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
24 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm2
- Type of wrap if used: linen cloth adhered to a synthetic film glue, bandage (Acrylastic) wrapped several times around the trunk

SCORING SYSTEM: Draize score

Results and discussion

Any other information on results incl. tables

An irritation index was not determined due to the corrosive effects observed.

An erythema could not be determined in all 3 animals because of the dark-brown discoloration of the treated skin areas after removal of the patches. The discoloured treated skin area was surrounded by a dark-red border in one animal.

An edema was observed in 1 animal approx. 2 cm around the treated skin area (grade 4). In the 2 other animals the treated skin area was surrounded by a moderate edema (grade 3).

24 hours after patch removal eschar formed in all 3 animals. The treated skin area showed deepenings of 1-2 mm. Animals were killed for animal welfare reasons.

Treated skin areas were exained microscopically. All 3 animals showed severe diffuse coagulation necrosis of the epidermis and the adjacent upper third to half of the corium. Furthermore animals showed demarcation of the necrotic skin parts by a small to medium sized zone of inflammatory cells, predominently neutrophilic granulocytes were found. In addition slight inflammatory cell infiltration, predominantly neutrophilic granulocytes, in the deeper corium, skin muscle and/or subcutic fatty tissue were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of this skin irritation test in the rabbit the test item is corrosive to the skin.