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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study completion date - 14 August 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:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate
EC Number:
264-129-6
EC Name:
Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate
Cas Number:
63405-85-6
Molecular formula:
C20H18N4O5S.Na
IUPAC Name:
sodium 3-({3-methoxy-4-[(4-methoxyphenyl)diazenyl]phenyl}diazenyl)benzenesulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
Name: FAT 20004/D
Purity: 61 %

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG, Gossau SG ad libitum
- Water: Water, ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 10 hour light cycle

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
Unwashed eye: unspecified (not rinsed after single instillation)
Washed eye: 30 sec
Observation period (in vivo):
The rabbits were examined for day 1, 2, 3, 4 and 7 d after application of the test.
Number of animals or in vitro replicates:
Six animals (Three males and three females)
Details on study design:
PROCEDURE:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control.

REMOVAL OF TEST SUBSTANCE: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water.

SCORING SYSTEM: The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed and rinsed eyes, respectively.

SCORING SYSTEM: Scale for scoring Ocular Lesions.
1.Cornea
(A) Opacity-degree of density (area most dense taken for reading)
- 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

AxBx5 Total maximum=80

2.Iris
(A) Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal 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, haemorrhage, gross destruction (any or all of these): 2
Ax5 Total maximum=10

3.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 adjacent to lids: 2
- Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
Score (a+b+c)x 2 Total maximum=20

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
Not rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1.11
Max. score:
4
Reversibility:
fully reversible within: 96 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Not rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Not rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 96 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
Not rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 96 h
Remarks on result:
no indication of irritation

Any other information on results incl. tables

  Unrinsed Eyes Rinsed Eyes
Days after Appl. Rabbit 1 (Male) Rabbit 2 (Male) Rabbit 3 (Male) Rabbit 4 (Female) Rabbit 5 (Female) Rabbit 6 (Female)
Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva
1 0 0 12 10 0 12 10 0 12 0 0 0 0 0 0 0 0 0
2 0 0 6 10 0 10 10 0 8 0 0 0 0 0 0 0 0 0
3 0 0 6 5 0 8 5 0 6 0 0 0 0 0 0 0 0 0
4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Cornea: 3.3 Iris: 0 Conjuctivae: 5.3 Cornea: 0 Iris: 0 Conjuctivae: 0

effect of rinsing R = unrinsed eyes 2.9

rinsed eyes 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was considered to be an non-irritant to rabbit eyes.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to procedure "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the six rabbits. The eyelids were then held closed for 1 second. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. In the present experiments the cornea, iris and conjunctivae scores were zero for rinsed eyes. Therefore, the test material was considered to be a non-irritant to rabbit eyes.

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