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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:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EEC-Guideline 8.5. Acute toxicity eye irritation regulation 84/449/EWG
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: Guideline 83/467/EWG
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 99.6%
- Composition of test material, percentage of components: p-Phenylenediamine, o-Chloroaniline, Aniline (total < 0.1%)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age: 3-5 months
- Weight : 2.3-2.8 kg
- Housing: Air-conditioned areas in single cages (battery system)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits, ad libitum as well as hay (approx. 15 g daily)
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3ºC
- Humidity (%): 50±20%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was untreated to serve as a control.
Amount / concentration applied:
100 mg test substance
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
Evaluations of the eyes took place 1, 24, 48 and 72 hours after application of the test substance.
Number of animals or in vitro replicates:
3
Details on study design:
About 24 hours before beginning of experiment were examined the eyes of the animals which can be treated after instillation of a drop of Fluorescein sodium solution (0.01%) under ultraviolet light for possible damage of the cornea. Only animals were taken into the experiment, whose eyes did not show any findings. On 3 rabbits were uniquely applied 100 mg o-Phenylenediamine in the conjuctival sack of the left eye. The untreated eye served in each case as control. 24 hours after application of the test substance as well as at all further evaluation times, on which the treated eyes showed still segregations or at those a cornea investigation with Fluorescein sodium solution took place, the treated eyes thoroughly with physiological saline solution (approx. 37°C) were washed. The evaluations of the eyes took place 1, 24, 48 and 72 hours after application of the test substance. For the evaluation dates 24 and 72 hours additionally after instillation of a drop Fluorescein sodium solution (0.01%) was examined the cornea under UV light for damage. Damage to the cornea, the iris and the connected skin was numerically evaluated. All other changes were recorded. Since after 72 hours still effects at the eye were present, an additional finding collection took place on 7 and 14 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
turbidity
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
2.3
Reversibility:
fully reversible
Irritation parameter:
iris score
Remarks:
dermatitis
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2.9
Max. score:
3.3
Reversibility:
fully reversible

Any other information on results incl. tables

Until 72 hours post application the Conjunctiva of all animals clear swelling to swelling with more than half-closed eyelids as well as vaguely strongly red coloring showed 1 hour. The iris of the animals were turned red. The cornea showed scattered to easily recognizably shining through opacity areas. 7 days post application were the Conjunctiva of the animals clearly swollen and vaguely crimson to strongly red colored. The iris of an animal was turned red. With an animal the cornea showed scattered opacity areas. In addition 1 hour to 7 days post application partial clear-browner to white-slimy discharge as well as brown and/or white discolorations and bleedings of the Conjuctiva and nictitating membranes were observed. 14 days post application all the irritation characteristics were reversible.

 

From the numerically evaluated individual studies at the observation times after 24, 48 and 72 hours the following average values were computed:

 

Cornea Turbidity

Iris Dermatitis

Conjunctiva Reddening

Conjunctiva Swelling

Average

2.1

1.0

3.0

2.9

Animal 1

2.3

1.0

3.0

3.3

Animal 2

2.0

1.0

3.0

2.3

Animal 3

2.0

1.0

3.0

3.0

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test substance was irritating to the eye.
Executive summary:

An eye irritation test was performed in accordance with OECD Guideline 405. On 3 rabbits were uniquely applied 100 mg o-Phenylenediamine in the conjuctival sack of the left eye. The untreated eye served in each case as control. The evaluations of the eyes took place 1, 24, 48 and 72 hours after application of the test substance. For the evaluation dates 24 and 72 hours additionally after instillation of a drop Fluorescein sodium solution (0.01%) was examined the cornea under UV light for damage. Damage to the cornea, the iris and the connected skin was numerically evaluated. All other changes were recorded. Since after 72 hours still effects at the eye were present, an additional finding collection took place on 7 and 14 days. The test substance was irritating to the eye.