o-phenylenediamine

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EEC-Guideline 8.5. Acute toxicity eye irritation regulation 84/449/EWG

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Guideline 83/467/EWG

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

o-phenylenediamine

EC Number:

202-430-6

EC Name:

o-phenylenediamine

Cas Number:

95-54-5

Molecular formula:

C6H8N2

IUPAC Name:

benzene-1,2-diamine

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

Results

Results 1

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

Results 2

Irritation parameter:

iris score

Remarks:

dermatitis

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Remarks:

reddening

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible

Results 4

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.