Registration Dossier
Registration Dossier
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EC number: 939-340-8 | CAS number: 28182-81-2
Skin irritation / corrosion
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:
- 1 992
- 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
- Reference substance name:
- Reference substance 001
- Cas Number:
- 28182-81-2
- Molecular formula:
- Unspecified (UVCB substance)
- Reference substance name:
- Hexamethylen diisocyanate, oligomerisation product (biuret type)
- IUPAC Name:
- Hexamethylen diisocyanate, oligomerisation product (biuret type)
Constituent 1
Constituent 2
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
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