Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 20 Nov, 1978 to 28 Nov, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

EC Number:

278-174-4

EC Name:

Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

Cas Number:

75284-35-4

Molecular formula:

C39H20Cu2N5O15S3.3Na

IUPAC Name:

trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Batch No.: EN 80524/76
- Physical appearance: Powder

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or tissues and environmental conditions:

The test was performed on 3 male and 3 female adult rabbits of the Himalayan breed (WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany) weighing 1.5 to 2 kgs. The animals were housed individually in metal cages, were kept at a constant room temperature of 22 ± 1 °C, at a relative humidity of 55±5 % and on a 10 hour light cycle day. The animals had ad libitum access to standard rabbit food - NAFAG, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

24 hours and after 2, 3, 4 and 7 days

Details on study design:

The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.

CORNEA:
A. Opacity and degree of density (most dense area scored)
No opacity 0
Scattered or diffuse area, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4

B. Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4

A x B x 5 Maximum possible score = 80

IRIS:
A. Values
Normal 0
Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2

A x 5 Maximum possible score = 10

CONJUNCTIVAE :
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

B. Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4

C. Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adj acent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3

(A + B + C) x 2 Maximum possible score = 20

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 11127/B was found to cause no irritation when applied to the rabbit eye mucosa.

Executive summary:

FAT 11127/B was tested for eye irritation potential according to the procedure adopted described in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO)".

0.1 g of test substance was introduced into conjuctival sac of the left eye of Russian rabbits (3 males and 3 females). The reactions on cornea, iris and conjuctivae were appraised with a slit-lamp after 24 hours and after 2,3,4 and 7 days. No irritation was seen with cornea, iris and conjunctivae at any of the observations. Therefore FAT 11127/B is to be considered to be a non-irritant to rabbit eye.