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Toxicological information

Skin irritation / corrosion

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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: Guideline study with GLP

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Desmodur VP.PU 1806
- Physical state: colorless, clear liquid
- Analytical purity: see composition of test material
- Composition of test material, percentage of components: 2,2'-Diisocyanatodiphenylmethane 0.64%, 2,4'-Diisocyanatodiphenylmethane 53.60% and 4,4'-Diisocyanatodiphenylmethane 45.72%.
- Manufacturer: Bayer AG, Liverkusen
- Stability under test conditions: guaranteed for the study period
- Storage condition of test material: room temperature, in nitrogen

Test animals

Species:
rabbit
Strain:
other: HC:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfaune UK Ltd.
- Mean body weight at study initiation: 3.52 Kg (3.1 - 3.7 Kg)
- Diet (e.g. ad libitum): Standard diet "Ssniff", approx. 100-120 g per animal/day, once per day in the morning
- Water (e.g. ad libitum): tap water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): approx. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin site of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6x6


REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully washed with water without altering the existing response, or the integrity of the epidermis.
- Time after start of exposure: 4 h


SCORING SYSTEM: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24-48-72 h
Score:
2.03
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24-48-72 h
Score:
1.43
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24-48-72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24-48-72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24-48-72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24-48-72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24-48-72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24-48-72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
The reactions extended beyond the exposed area. Eschar formation was observed in 1 animal from 72 h to 7 days and in 2 animals on day 7. The exposed site was covered by a whitish scaly layer in 2 animals after 7 days and in 2 additional animals on day 14.

Any other information on results incl. tables

Animal

No.

DRAIZE grade after

Mean

(24-48-72 h)

1h

24h

48h

72h

7days

14days

E

O

E

O

E

O

E

O

E

O

E

O

E

O

1

1

0

2

0

2

0

2

0

2

3

0

0

2.0

0.0

2

1

0

2

0

1

0

1

0

2

2

2

0

1.3

0.0

3

1

0

2

0

1

0

1

0

3

3

2

0

1.3

0.0

4

1

0

2

2

2

3

4

3

4

4

2

2

2.7

2.7

5

0

0

2

2

2

3

3

4

4

4

3

2

2.3

3.0

6

0

0

2

2

3

3

3

4

4

4

3

2

2.7

3.0

Mean

0.7

0.0

2.0

1.0

1.8

1.5

2.3

1.8

3.2

3.3

2.0

1.0

Mean of 6 animals (24-48-72 h)

E = 2.03

O = 1.43

E: erythema and eschar formation

O: oedema formation

Applicant's summary and conclusion

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