Reaction mass of 3-(2-{3-cyanato-5-[2-(3-cyanatoaryl)heteropolycycle-5-yl]aryl}heteropolycycle-5-yl)aryl cyanate and heteropolycycle -2,5-diyldi-3,1-arylene dicyanate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 February 2011 - 29 July 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 437

Deviations:

no

Principles of method if other than guideline:

The Bovine Corneal Opacity & Permeability Assay (BCOP) which was developed by Pierre Gautheron 1992 as an in vitro alternative to the in vivo Draize Eye Irritation test. The assay uses isolated bovine corneas as a means of assessing the ocular irritancy potential of test substances in vitro.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

LZ1554

IUPAC Name:

LZ1554

Details on test material:

- Name of test material (as cited in study report): LZ1554
- Physical state: Highly viscous brownish liquid
- Expiration date of the lot/batch: 15 July 2012
- Storage condition of test material: Room temperature in the dark, under nitrogen

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

Test animals are not used in this In-Vitro study.

Test system

Amount / concentration applied:

Corneas were treated in triplicate with either the test substance, positive control (10% w/v sodium hydroxide) or negative control (0.9% sodium chloride solution).

Duration of treatment / exposure:

The test material or controls were in contact with the cornea for a total of 10 minutes (± 30 seconds). Each holder was incubated in a horizontal position at 32°C ± 1°C in a waterbath.

Observation period (in vivo):

Following completion of the two hour incubation period, the medium was removed from both compartments and replaced with fresh cMEM. The posterior compartment was re-plugged and the opacity of each cornea measured and recorded. The opacity values obtained at this stage were used in calculating the final In Vitro Irritancy Score.

Number of animals or in vitro replicates:

No animals used as method carried out was an in-vitro method.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

0.5

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test substance, LZ1554, elicited an In Vitro Irritancy Score of 0.5 ± 1.9 and was predicted to be a non corrosive/ non severe eye irritant.

Executive summary:

The eye irritation potential was determined in a GLP-compliant study in accordance with OECD no. 437 (BCOP method). The test substance, LZ1554, elicited an In Vitro Irritancy Score of 0.5 ± 1.9 and was predicted to be a non corrosive/ non severe eye irritant.