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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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 405 (Acute Eye 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 3175
- Composition of test material, percentage of components: 75% Polyisocyanurate blocked with 2-butanonoxime, 25% Solventnaphta
- 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, sponsor responsability
- Storage condition of test material: room temperature, in darkness

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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=3.0 kg; animal 3=2.8 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

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

0.1 mL of the test substance was instilled into the conjunctival sac of one eye of each animals after gently pulling the lower lid away from the eyeball,
the lids were then gently held together for about one second.

Observation period (in vivo):

The animals were observed at 1, 24, 48, 72 hours and 7, 14 and 21 days after instillation of the test substance.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with physiological NaCl solution .
- Time after start of exposure: 24 hours after the instillation of the test substance


SCORING SYSTEM: The sign of cornea, iris, conjunctivae and discharge were recorded as describe by Draize scale; the aqueous humour as described by Mcdonald and Shadduck.


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48,72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

No irritant effect has been observed and recorded on the eye until day 21.

Other effects:

No aqueous humour discharge has been observed and recorded in any animals.

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	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 0	Max. score: 0	Max. score: 0	Max. score: 0
24 h	0/0/0	0/0/0	0/0/0	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0.0/0.0/0.0	0.0/0.0/0.0	0.0/0.0/0.0	0.0/0.0/0.0
Reversibility*)	-	-	-	-

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, DESMODUR BL 3175 is not classified as irritating to eye 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).

Executive summary:

In a primary eye irritation study, conducted according to the OECD 405 guideline, in compliance with GLP, 0.1 mL of Desmodur BL 3175 was instilled into the conjunctival sac of 3 adult albino NZW rabbits. Treated eyes were washed with physiological NaCl solution 24 hours after instillation of the test substance. Animals were then observed for 21 days. Irritation was scored by the method of Draize and aqueous humour discharge by the method of Mcdonald and Shadduck.

The mean individual scores were 0.0 for cornea, iris, conjunctivae and chemosis. No aqueous humour discharges was observed.

Under the test conditions, DESMODUR BL 3175 is not classified as irritating to the eye according to the criteria of Annex VI to the Directive 67/548/EEC and to the criteria of Annex I to the CLP Regulation (EC) N° (1272-2008).