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 and OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

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
Details on test material:
- Name of test material (as cited in study report):
- Lot/batch No.: 04 ILDC 005/6

- Physical state: liquid
- Analytical purity: 97%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.2-2.8 kg
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3ºC
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h or 3 min.
Observation period:
7 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5cm/2.5cm
- % coverage: form Beiersdorf comp.
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 3min. or 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 h
Score:
2
Max. score:
2
Reversibility:
other: open wound
Remarks on result:
other: after 7 days open wound
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72 h
Score:
1
Max. score:
2
Reversibility:
other: open wound
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritant / corrosive response data:
corrosive
Other effects:
erithe and eschar. Edema.

Any other information on results incl. tables

Exposure 4 hours

time

30-60 min.

24h

48h

72h

7days

animal

1

1

1

1

 

Erytherm and eschar

2

2

2

2

impossible to judge – open wound

edema

2

2

1

1

impossible to judge – open wound

Skin discoloration

x

x

x

x

 

Erythema

 

x

x

x

 

Open wound, with redness

 

 

 

 

x

Exposure 3 minutes

time

30-60 min.

24h

48h

72h

animal

2

2

2

2

Erytherm and eschar

2

3

3

3

edema

2

2

3

2

Skin discoloration

x

x

x

x

Erythema

x

x

x

x

Open wound, with redness

x

x

x

x

Open wound

 

 

 

x

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substancae applied caused severe burns of the animals' skin. The animal with exposure of 3 min. had erythema, edeme and wound 72 hours after exposition and the one with 4 hours of exposition had an open wound 7 days after the exposition.
Executive summary:

The substancae applied caused severe burns of the animals' skin. The animal with exposure of 3 min. had erythema, edeme and wound 72 hours after exposition and the one with 4 hours of exposition had an open wound 7 days after the exposition.