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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:
1982
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:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study". Federal Register, Vol. 43 No. 163 August 22, 1978
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)
EC Number:
943-062-2
Molecular formula:
not available
IUPAC Name:
Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
Code No: FAT 20036/D
Batch No: EN 91018.22
Stability: May 1987
Description: Powder
Test Article Received: June 6, 1982

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Hadoerin AG, CH-4414 Fuellinsdorf.
- Weight at study initiation: between 2 to 3 kg.
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit foodr NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland).
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 4 days.
- Individual identification: ear numbers.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod: 12 hours light cycle day and approximately 15 air changes/h.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Right eye of each rabbit remained untreated and served as a control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
One single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 male and 3 female rabbits
Details on study design:
The test material (0.1 g) was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. In 3 of the 6 rabbits, approximately 30 seconds later, In after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.
The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment.


SCORING SYSTEM:
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 aereas, 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 theses or combination of any thereof) iris still reaction 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 conjunctiva 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 nictating 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 l i d s and hairs, and considerable area around the eye: 3
(A + B + C) x 2
Maximum possible score : 20

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Rinsed and non rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
Rinsed and Unrinsed eye
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Rinsed and unrinsed eye
Time point:
24/48/72 h
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Rinsed and unrinsed eyes
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
FAT 20'036/D was found to cause miniaal irritation when applied to the rabbit eye mucosa.
- PRIMARY IRRITATION INDEX IN UNRINSED EYES: A= 6.7 : 5 = 1.3
- PRIMARY IRRITATION INDEX IN RINSED EYES: B= 4.0 : 5 = 0.8
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20'036/D was concluded to be not an eye irritant.
Executive summary:

An acute eye irritation study was performed on New Zealand white rabbits to determine the irritant potency of FAT 20036/D. The procedure used is based, but not in

every part identical with the Proposed Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study". Federal Register, Vol. 43 No. 163 August 22, 1978. The test material (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.

 

No irritation reactions were noticed with cornea and iris. The scores obtained for conjunctival redness and chemosis were below the threshold scores for classification as established by Regulation (EC) No. 1272/2008. The calculated primary irritation index was: 1.3 in unrinsed eyes and 0.8 in rinsed eyes. Hence, it can be concluded that under the conditions of the present experiment FAT 20036/D is not an irritant to eyes.