p-phenylenediamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was not conducted under GLP. Limited information provided on animals used and environmental conditions. Study conducted outside of current guidelines. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Details on test animals and environmental conditions not reported.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Details on test material:

- Purity: 99.5%

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg of solid material

Duration of treatment / exposure:

Ten mg of solid test material was placed into the right conjunctival sac of each of 2 male albino rabbits. After 20 seconds, 1 treated eye was washed with tap water for 1 minute. The treated eye of the other rabbit was not washed.

Observation period (in vivo):

Observations of the cornea, iris and conjunctiva were made with an ophthalmoscope at 1 and 4 hours, and at 1, 2, 3, 7 and 14 days; Fluor-i-strip stain and a slit-lamp biomicroscope were used at examinations after the day of treatment.

Number of animals or in vitro replicates:

2 albino male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): One treated eye was washed with tap water for 1 minute. The treated eye of the other rabbit was not washed.
- Time after start of exposure: 10 mg of solid test material was placed into the right conjunctival sac of each of 2 male albino rabbits. After 20 seconds, 1 treated eye was washed with tap water for 1 minute.

TOOL USED TO ASSESS SCORE: Ophthalmoscope at 1 and 4 hours, and at 1, 2, 3, 7 and 14 days; Fluor-i-strip stain and a slit-lamp biomicroscope at examinations after the day of treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: See Table 1

Time point:

24/48/72 h

Reversibility:

other: See Table 1

Remarks on result:

other: See Table 1

Remarks:

"Any other information on results incl. tables"

Results 2

Irritation parameter:

iris score

Basis:

other: See Table 1

Time point:

24/48/72 h

Reversibility:

other: See Table 1

Remarks on result:

other: See Table 1

Remarks:

"Any other information on results incl. tables"

Results 3

Irritation parameter:

conjunctivae score

Basis:

other: See Table 1

Time point:

24/48/72 h

Reversibility:

other: See Table 1

Remarks on result:

other: See Table 1

Remarks:

"Any other information on results incl. tables"

Results 4

Irritation parameter:

chemosis score

Basis:

other: See Table 1

Time point:

24/48/72 h

Reversibility:

other: See Table 1

Remarks on result:

other: See Table 1

Remarks:

"Any other information on results incl. tables"

Irritant / corrosive response data:

See Table 1

Any other information on results incl. tables

Table 1: Ocular Effects
Dose	Treatment	Cornea	Iris	Conjunctiva
10 mg solid test material	Unwashed	A generalized area of slight cloudiness 1-4 hours. A small area of slight cloudiness at 1 day.	Moderate congestion 2-3 days.	Redness: Mild 1 hr.-1day and 3-7 days. Moderate at 2 days. Swelling: Slight at 1 hr. and mild 4 hrs.-1 day. Discharge: Mild 4 hrs.-1 days.
10 mg solid test material	Washed	A generalized area of slight cloudiness 1 hr.-1 day and decreasing to a moderate area of slight cloudiness at 2 days and a small area of slight cloudiness at 3 days.	Moderate congestion 4 hrs.- 3 days.	Redness: Mild 1 hr.-7 days. Swelling: Slight 2-4 hrs. Discharge: None.

 

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). A 10 mg aliquot of the test substance produced generalized slight corneal cloudiness, moderate iritis and moderate conjunctivitis in an unwashed rabbit eye. An eye treated and promptly washed had generalized slight corneal cloudiness, moderate iritis and mild conjunctivitis. Both eyes were normal within 14 days after treatment. This material produced moderate ocular effects.

Executive summary:

The test substance was evaluated for acute eye irritation potential in male albino rabbits. A 10 mg aliquot of the test substance produced generalized slight corneal cloudiness, moderate iritis and moderate conjunctivitis in an unwashed rabbit eye. An eye treated and promptly washed had generalized slight corneal cloudiness, moderate iritis and mild conjunctivitis. Both eyes were normal within 14 days after treatment. This material produced moderate ocular effects.