[1,1'-Bianthracene]-9,9',10,10'-tetrone, 4,4'-bis[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl]amino]-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1991 to January 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD guideline under GLP

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:

1992

Report date:

1992

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 relevant

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

308 AQN

IUPAC Name:

308 AQN

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

One new Zealand White rabbit was supplied by David Percival Ltd., Moston, sandbach, Cheshire, U.K. At the start of the study the animal weighed 2.26 kg and was approximately twelve to sixteen weeks old. After a minimum acclimatisation period of five days the animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on a cage label.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1ml = 65 mg

Duration of treatment / exposure:

The upper and the lower eyelids were held together for about one second.

Observation period (in vivo):

1 hour, 24 and 48 hours

Number of animals or in vitro replicates:

1

Details on study design:

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #1

Time point:

other: 48h

Score:

81

Reversibility:

not specified

Irritant / corrosive response data:

A dulling of the normal lustre of the corneal surface was noted in the treated eye one hour after treatment. Opalescent corneal opacity was noted in the treated eye at the 24-hour observation, with areas of opaque corneal opacity at the 48-hour observation. Corneal opacity was confirmed using sodium fluorescein B.P. in the treated eye one hour after treatment and at the 24 and 48-hour observations.

Iridial inflammation was noted in the treated eye one hour after treatment and at the 24 and 48-hour observations.

Moderate conjunctival irritation was noted in the treated eye one hour after treatment with severe conjunctival irritation at the 24 and 48-hour observations. A Pale appearance of the nictitating membrane was also noted at the 48-hour observation.

Any other information on results incl. tables

A dulling of the normal lustre of the corneal surface was noted in the treated eye one hour after treatment. Opalescent corneal opacity was noted in the treated eye at the 24-hour observation, with areas of opaque corneal opacity at the 48-hour observation. Corneal opacity was confirmed using sodium fluorescein B.P. in the treated eye one hour after treatment and at the 24 and 48-hour observations.

Iridial inflammation was noted in the treated eye one hour after treatment and at the 24 and 48-hour observations.

Moderate conjunctival irritation was noted in the treated eye one hour after treatment with severe conjunctival irritation at the 24 and 48-hour observations. A Pale appearance of the nictitating membrane was also noted at the 48-hour observation.

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: Modified Kay and Calandra Interpretation of Eye Irritation Test

Conclusions:

The test material, No. 308 AQN, produced a maximum total score of 81 and was considered to be at least a very severe irritant (class 7 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit only).

Executive summary:

The test material, No. 308 AQN, produced a maximum total score of 81 and was considered to be at least a very severe irritant (class 7 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit only).

It is also reasonable to assume the symbol "Xi" and at least the risk phrase R 35 "Irritation to Eyes" according to EEC labeling regulations.