Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, 3,5-dimethyl-1H-pyrazole-blocked

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(2002)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 3,5-dimethyl-1H-pyrazole

EC Number:

606-423-2

Cas Number:

200295-52-9

Molecular formula:

>= C51H78N12O6 (IPDI-Isocyanurate n=3, blocked with 3,5-dimethylpyrazole)

IUPAC Name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 3,5-dimethyl-1H-pyrazole

Test material form:

solid: crystalline

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: Albino rabbits Crl: KBL(NZW)BR
- Sex: female
- Source: Charles River, 88353 Kisslegg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 2.6 - 3.1 g
- Housing: individually in cage units Metall/Noryl by EBECO
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

The lids were gently held together for about one second in order to prevent loss of test material. The eye was not rinsed for at least 24 hours following treatment.

Observation period (in vivo):

Animals were monitored until the changes had completely subsided, however, for not more than 21 days after application.

Number of animals or in vitro replicates:

3

Details on study design:

On the day before the test, both eyes of each animal were examined including fluorescein examination. Only animals with healthy intact eyes were used.
0.1 g of the pulverized test substance was placed into the conjunctival sac of one eye of the first animal after having gently pulled the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the test material. The other eye, which remained untreated, served as control.

Due to a possible irritant potential of the test substance, in the first step only one animal was used. If one hour after treatment a severe irritation was not observed, two further rabbits were treated as described.

REMOVAL OF TEST SUBSTANCE
The eye was not rinsed for at least 24 hours following treatment.

OBSERVATION TIME POINTS
Eye irritation was scored and recorded approx. at 1, 24, 48 and 72 hours post application. If no irritation indices were observed after 72 hours, the study was finished. If eye irritation was observed, animals were monitored usually on day 7, 14 and 21 after application until the changes had completely subsided, however, for not more than 21 days after application.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: mean score: 0.3

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 3

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Other effects:

There were no relevant systemic intolerance reactions.

Applicant's summary and conclusion

Executive summary:

A test on eye irritation/damage to the eye was conducted according to OECD TG 405 on three rabbits that were each administered 0.1 g of the unchanged test substance into the lower lid of one eye. With respect to animal welfare a stepwise approach was chosen. In the first step only one animal was used. If one hour after treatment a severe irritation was not observed, two further rabbits were treated likewise. Eye irritation was scored and recorded approx. at 1, 24, 48 and 72 hours post application. If no irritation indices were observed after 72 hours, the study was finished. If eye irritation was observed, animals were monitored usually on day 7, 14 and 21 after application until the changes had completely subsided, however, for not more than 21 days after application.

As result a single application of 0.1 g test substance per animal into the conjunctival sac did not cause changes in cornea opacity, iris and chemosis. For conjunctiva (redness) only a slight effect was noted after 24 hours for two of three rabbits (score 1). Changes were completely subsided after 48 hours at the latest. There were no systemic intolerance reactions.