2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Source study has reliability 1; details on the read-across approach are attached in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: 3.5 kg
- Accommodation: individual cages
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Humidity: 40 - 60 %
- Photoperiod: 12 hours light and 12 hours dark

Test system

Controls:

other: untreated eye used as control

Amount / concentration applied:

0.1 g test substance.

Duration of treatment / exposure:

24 hours.

Number of animals or in vitro replicates:

3 males.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with physiological solution of NaCl.
- Time after start of exposure: 24 hours.

SCORING SYSTEM: Draize scale for ocular lesions (1944)
Cornea
Degree of opacity (most dense area used)
0 no opacity
1 scattered or diffuse areas, details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 opalescent areas, no details of iris visible, size of pupil barely discernible
4 opaque cornea, iris invisible

Area of cornea involved:
1 one quarter or less but not zero
2 greater than one quarter, but less than half
3 greater than half, but less than three quarters
4 greater than three quarters, up to whole area


Iris
0 normal
1 folds above normal, congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, hemorrhage, gross detsruction (any or all of these)


Conjuctivae
Redness (refers to palpebral and bulbar conjuctivae, excluding cornea and iris)
0 vessels normal
1 vessels definitely injected above normal
2 more diffuse, deeper crimson red, individual vessels not easily discernible
3 diffuse beefy red

Chemosis:
0 no swelling
1 any swelling above normal (includes nictitating membranes)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half closed
4 swelling with lids more than half closed

Discharge:
0 no discharge
1 any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 discharge with moistening of the lids and hairs just adjacent to lids
3 discharge with moistening of the lids and hairs, and considerable area around the eye

TOOL USED TO ASSESS SCORE: one drop of 1 % fluorescein applied in the eye, then rinse with physiological NaCl solution and examination under UV light.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 2/3

Time point:

other: 24, 48, 72 h

Score:

< 1

Reversibility:

fully reversible within: 21 d

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 1/3

Time point:

other: 24, 48, 72 h

Score:

> 1

Reversibility:

fully reversible within: 21 d

Results 3

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

other: 24, 48, 72 h

Score:

< 1

Reversibility:

fully reversible within: 21 d

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

other: 24, 48, 72 h

Score:

< 2

Reversibility:

fully reversible within: 21 d

Results 5

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

other: 24, 48, 72 h

Score:

< 2

Reversibility:

fully reversible within: 21 d

Any other information on results incl. tables

	1h			24h			48h			72h			7d			21d
animal	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
corneal opacicity	0	0	0	0	1	0	1	2	0	1	2	0	0	2	0	-	0	-
corneal surface	0	0	0	0	3	0	1	2	0	1	2	0	0	4	0	-	0	-
iris	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	-	0	-
conjuctivae redness	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	-	0	-
chemosis	0	0	0	1	1	1	1	1	0	1	1	1	0	1	0	-	0	-

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

Under test conditions, the substance is not irritant to the rabbit eye.

Executive summary:

Method

Eye irritation study was conducted in 3 male rabbits by instillation of 0.1 g of test material into one eye (the other eye serves as control). After 24 hours, rinse of eye was done with physiological NaCl solution. Observation and scoring were carried out at 1h, 24 h, 48 h, 72 h, 7 d and 21 d after application, based on the Draize scale (1944).

Result

Animals were observed for corneal opacity, iritis, conjuctival redness and chemosis. A score was associated to each animal at each time point. Evaluation was done averaging over results at 24, 48 and 72 hours and considering reversibility within 21 days. All responses were fully reversible within 21 days.