Hexamethylene diisocyanate, oligomerisation product, blocked with 2-butanone oxime

Skin irritation / corrosion

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

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

Results

Results 1

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

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

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

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 5

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

Results 6

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).