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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: GLP study, guideline study; no data on test substance purity

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Reference substance 002
Cas Number:
28182-81-2
Molecular formula:
Unspecified (UVCB substance)
Constituent 2
Reference substance name:
Hexamethylen diisocyanate, oligomerisation product (biuret type)
IUPAC Name:
Hexamethylen diisocyanate, oligomerisation product (biuret type)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach
- Age at study initiation: adult animals
- Weight at study initiation: 3.02, 2.93 and 2.94 kg (3 males)
- Housing: single housing, cage made of stainless steel with wire mesh walk floors, (40 cm x 51 cm), no bedding in the cages
- Diet: Kliba Labordiaet 341, 4 mm, Klingentalmuehle AG, CH-Kaiseraugust, Switzerland (about 130 g/animal/day)
- Water: tap water, about 250 mL/animal/day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated site of the same animal served as control
Amount / concentration applied:
approx. 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
8 days (as no skin reaction was observed at that time)
- Frequency of readings: about 1 h after removal of the patch; 24, 48, 72 h and 8 days after application
- Frequency of observation: twice each workday and once on saturday, sunday and public holidays
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: the test patch was secured with a semiocclusive dressing.

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

SCORING SYSTEM: evaluation was performed according to the Draize Scoring System.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Table 1: Details on results

Readings

Animal No.

Erythema

Edema

1h

1

0

0

2

1

0

3

0

0

24 h

1

1

0

2

2

1

3

2

1

48 h

1

0

0

2

2

0

3

2

0

72 h

1

0

0

2

1

0

3

0

0

8 d

1

0

0

2

0

0

3

0

0

Mean

(24 – 72 h)

1

0.33

0.00

2

1.67

0.33

3

1.33

0.33

Mean

 

1.11

0.22

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information