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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
Study period:
1989-11-28 to 1989-12-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well-conducted guideline study, GLP, no deviations
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Desmodur BL 3175
IUPAC Name:
Desmodur BL 3175
Details on test material:
- Name of test material (as cited in study report): DESMODUR BL 3175
- Composition of test material, percentage of components: 75% Polyisocyanurate blocked with 2-Butanonoxime; 25% Solventnaphta 100
- Physical state: yellowish transparent liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: 214
- Expiration date of the lot/batch: no data
- Stability under test conditions: guaranted for the study period, responsability of the sponsor
- Storage condition of test material: room temperature, in darkness

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult
- Weight at study initiation: animal 1=2.9 kg; animal 2=3.3 kg; animal 3=3.2 kg
- Housing: individually housed in stainless steel cages
- Diet (e.g. ad libitum): standard diet (Ssniff K 4) once per day in the morning
- Water (e.g. ad libitum): ad libitum
- Acclimation period:at least 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3°C
- Humidity (%): approx. 50%
- Air changes (per hr): Approx. 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial illimination from 6 to 18 hours CET


IN-LIFE DATES: From: To: No data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorso lateral area of the trunk
- % coverage: 6 cm2
- Type of wrap if used: a semi-occlusive dressing (Fixomull - Stretch Klebevlies)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: not reversible at day 14, score of 1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: not fully reversible at day 14, score of 1
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24,48, 72h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: not fully reversible at day 14, score of 1
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Other effects:
no data

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score:

Max. score:

24 h

2/2/2 

 0/0/0 

48 h

2/2/2 

 0/0/0 

72 h

2/2/2 

 0/0/0 

Average 24h, 48h, 72h

 2.0/2.0/2.0

 0.0/0.0/0.0

Reversibility*)

NC

 C

Average time (unit) for reversion

NC

 -

NC: not completely reversible C: completely reversible

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, DESMODUR BL 3175 is classified as irritating to the skin according to the criteria of the Annex VI of the Directive
67/548/EEC and the Annex I of the CLP Regulation (EC) N°( 1272-2008).
Executive summary:

In a primary dermal irritation study conducted according to the OECD 404 guideline in compliance with GLP, 3 adult albino rabbits NZW were dermally exposed to 0.5 mL of Desmodur BL 3175 for 4 hours to 6% of the dorso lateral area of the trunk. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were observed for 14 days. Irritation was scored by the DRAIZE scale. The skin reactions were assessed at 1, 24, 48, 72 hours, 7 and 14 days after removal of the dressing. The mean individual scores were calculated across 3 scoring times at 24, 48 and 72 hours after patch removal, for each animal.

The mean individual scores were 2.0/2.0/2.0 for erythema and 0.0/0.0/.0./ for edema. At the end of the observation period, the animals scores for erythema at Day 14 were 1.0/1.0/1.0, not completely reversible.

Under the test conditions, DESMODUR BL 3175 is classified as irritating to the skin according to the criteria of the Annex VI of the Directive 67/548/EEC and to the Annex I of the CLP Regulation (EC) N°( 1272-2008).