Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 19 February 1992 to 21 February 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Test material: NSABZ (2-(Naphthalene-2'-sulphonylamino)-benzoic acid)
Date of receipt: 20 December 1991.
Description: Very light brown powder.
Storage: In original container at room temperature.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Data relating to the identity, purity and stability of the test material are the responsibility of the sponsor.
- Storage condition of test material: room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test material was used as provided

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.77 kg
- Housing: individual housing in a suspended metal cage
- Diet (e.g. ad libitum): free access throughout the study (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol)
- Water (e.g. ad libitum): free access throughout the study
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21°C
- Humidity (%): 50 - 56%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the test material (approximately 59 mg)
- Concentration (if solution): not specified
- Control: left eye remained untreated and was used for control purposes
Duration of treatment / exposure:
48h
Observation period (in vivo):
1h, 24h, 48 h
Number of animals or in vitro replicates:
1
Details on study design:
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24 and 48 hours following treatment, according to the numerical evaluation given in Appendix I, (from Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics").

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
15
Max. score:
40
Reversibility:
other: Not reversible. due to persistence of opacy (grade of 4), the animals were killed after the 48h observation period.
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
40
Max. score:
40
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
other: due to persistence of opacy (grade of 4), the animals were killed after the 48h observation period.
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
other: due to persistence of opacy (grade of 4), the animals were killed after the 48h observation period.
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Residual test material was noted around the treated eye one hour after treatment.
Areas of diffuse corneal opacity were noted in the treated eye one hour after treatment. A small area, approximately 5 mm x 5mm, of grade 4 corneal opacity was noted in the treated eye at the 24 and 48-hour observations with diffuse to translucent corneal opacity in the remaining affected area of the treated eye.
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 and at the 24 and 48-hour observations. Adherence of the test material to the nictitating membrane and lower conjunctival membrane was also noted at the 24 and 48-hour observations.
Due to the persistance of the grade 4 opacity the animal was killed for humane reasons immediately after the 48-hour observation in accordance with current U.K. Home Office guidelines. No further animals were treated.

Any other information on results incl. tables

For information, the individual scores and total scores on tested rabbit are provided below:

Time after treatment

1h

24h

48h

 

Cornea

E = degree of opacity

1

4ab

4ab

 

F = area of oapacity

3

2

2

 

Score (ExF)x5

15

40

40

 

Iris

D

1

1

1

 

Score (Dx5)

5

5

5

 

Conjunctivae

A = Redness

2

2tm

2tm

 

B = Chemosis

2

2b

2b

 

C = Discharge

3RE

3

3

 

Score (A+B+C)x2

14

14

14

 

Total score

34

59

59

 

a = grade 4 opacity over small area (5mm x 5mm) with grade 1 or 2 opacity over remainder of affected area

b = positive critria

tm = test material adhered to nictitating membrane and lower conjunctival membrane

RE = residual test material around treated eye

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test was only carried out with one animal and is therefore insufficient for classification, but the evidence shows that 2 -(Naphtalene-2'-sulphonylamino)-benzoic acid could be classified according to EC labeling regulations, into Category 1 - producing serious eye damage.
Executive summary:

A study was performed to assess the irritancy potential of the 2 -(Naphtalene-2'-sulphonylamino)-benzoic acid to the eye of the New Zealand White rabbit, following the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" of 1987. A single application of the test material to the non-irrigated eye of one rabbit produced grade 4 corneal opacity, iridial inflammation and moderate conjunctival irritation. Although the test was only carried out with one animal and is therefore insufficient for classification, the evidence shows, that the test material could be classified according to EC labeling regulations into Category 1 - producing serious eye damage.