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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6,8-dianilinonaphthalene-1-sulphonic acid
EC Number:
204-970-8
EC Name:
6,8-dianilinonaphthalene-1-sulphonic acid
Cas Number:
129-93-1
Molecular formula:
C22H18N2O3S
IUPAC Name:
6,8-dianilinonaphthalene-1-sulfonic acid
Test material form:
solid

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
- Weight at study initiation: 2.60 kg
- Housing: individually in a suspended metal cage
- Diet (e.g. ad libitum): (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, ad libitum
- Water (e.g. ad libitum): mains drinking water, ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 60 - 64
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test material, which was found to weigh approximately 83 mg
Duration of treatment / exposure:
Single applikation. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. The animal was killed after the 72-hour observation.
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: not reported

SCORING SYSTEM: Draize J.H. 1959

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: the shortened observation period of 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: the shortened observation period of 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
not fully reversible within: the shortened observation period of 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: the shortened observation period of 72 h
Irritant / corrosive response data:
Faint green-coloured staining over the nictitating membrane was commonly noted in the treated eye. Residual test material was noted around the treated eye during the study.

Areas of diffuse corneal opacity were noted in the treated eye one hour after treatment with areas of translucent corneal opacity at the 24-hour observation. Opalescent opacity was noted on the lower region of the cornea with translucent corneal opacity over the remaining area at the 48 and 72-hour observations.

Severe conjunctival irritation was noted in the treated eye one hour after treatment and at the 24, 48 and 72-hour observations. Other adverse reactions noted were haemorrhage over a small area of the nictitating membrane and a pale appearance of the nictitating membrane.


Due to the severity of the ocular reactions the animal was killed for humane reasons immediately after the 72-hour observation. No further animals were treated.
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
mean scores of animal # 1:

Cornea: 2.7
Iris: 1.0
Conjunctivae
redness: 2.7
chemosis: 3.0

irreversible effects on the eye within the shortened observation period of 72 h
Executive summary:

The substance was tested for eye irritation according to OECD guideline 405. In the conjunctival sac of the right eye of one New Zealand White rabbit 0.1 ml of the test material was placed. Severe conjunctival irritation was noted.