Benzene-1,4-diammonium sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

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.

Justification for type of information:

Data is from experimental report

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.

Principles of method if other than guideline:

The eye irritation study of test chemical was condcuted on rabbits according to OECD Guideline 405 (Acute Eye Irritation / Corrosion).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

p-phenylenediamine

EC Number:

203-404-7

EC Name:

p-phenylenediamine

Cas Number:

106-50-3

Molecular formula:

C6H8N2

IUPAC Name:

benzene-1,4-diamine

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 reportedENVIRONMENTAL 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

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 3 days

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Irritation was observed in treated rabbits.

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:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test chemical was considered to be moderately irritating to the treated albino rabbits.

Executive summary:

An eye irritation test was conducted to evaluate the ocular effects caused by the chemical OECD Guideline 405 (Acute Eye Irritation / Corrosion).

About 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.

Since the test material produced moderate ocular effects, it was considered as irritating to the eyes of treated rabbits.