4-chloroaniline

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Verordnung über gefährliche Stoffe (Gefahrstoffverordung-GefStoffV ) vom 26. August 1986 (BGB1. I S. 1470)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-chloroaniline

EC Number:

203-401-0

EC Name:

4-chloroaniline

Cas Number:

106-47-8

Molecular formula:

C6H6ClN

IUPAC Name:

4-chloroaniline

Details on test material:

- Name of test material (as cited in study report): p-chloranilin, DS
- Physical state: solid (crystalline light-brown product)
- Analytical purity: 99.5%
- Purity test date: 12.09.1990
- Product number/code: Hoe CG 0080 OD ZD00 0002
- Storage condition of test material: at 20°C in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hochst AG, Kastengrund, Germany, conventional breeding
- Age at study initiation: about 3-5 months
- Weight at study initiation: 3.8-4.3 kg
- Housing: animals were housed in individual cages in full air-conditioned rooms
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät-Kaninchen, Altromin GmbH, Lage/Lippe, Germany, ad libitum plus hey (about 15 g daily)
- Water (e.g. ad libitum): deionized, chlorinated water from automatic drinking trough ad libitum

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


IN-LIFE DATES: From: 03.07.1990 To: 17.07.1990

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours, and 7 days after the exposure

Number of animals or in vitro replicates:

3

Details on study design:

- Washing (if done): yes, with physiologic saline solution
- Time after start of exposure: at 24 hours after exposure, and at all the other time points. The washing was performed also when excretions were observed in the treated eyes and when the fluorescein test was performed on the cornea of the treated eyes.

SCORING SYSTEM: Draize score

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 2 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 2 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 2 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 1 days

Irritant / corrosive response data:

At 1 and 24 hours post-exposure the conjunctiva of the animals showed the following effects: from a diffuse, carmine red colour to a diffuse, strong red colour and from a slight to clear swelling. 24 hours post exposure the iris of the animals was reddened and the cornea showed a diffuse opacity. 48 hours post-exposure an obvious hyperaemia of some vasculature of the conjunctiva and a diffuse carmine red colour of the conjunctiva were observed respectively. Two animals showed a slight swelling of the conjunctiva. Still at 72 hours post-exposure a marked hyperaemia of some vasculature of the conjunctiva was observed on two animals.
The appearance of the irritation was accompanied from a clear, colourless discharge. All irritation symptoms were reversible 7 days after the exposure.

Any other information on results incl. tables

Time endpoint after application	24h			48h			72 h			Mean (24-72 h)
Animal number	81	173	200	81	173	200	81	173	200	All animals
Conjuctiva: Chemosis	1	1	1	1	1	0	0	0	0	0.6
Conjuctiva: redness	3	3	2	2	2	1	1	1	0	1.7
Iris	1	1	1	0	0	0	0	0	0	0.3
Corneal opacity	1	1	1	0	0	0	0	0	0	0.3
Fluoresceintest	2	3	2				1	1	0	0

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:

other: no labeling required

Remarks:

Criteria used for interpretation of results: EU

Executive summary:

Kreiling (Hoechst AG, 1990):

A eye irritation test was conducted on rabbits according to OECD guideline 404.

100 mg of 4-Chloranilin was applied in the conjunctival sac of the left eye of each rabbits. The observation of the eyes was performed 1, 24, 48, and 72 hours after the application of the test substance. At 1 and 24 hours post-exposure the conjunctiva of the animals showed the following effects: from a diffuse, carmine red colour to a diffuse, strong red colour and from a slight to clear swelling. 24 hours post exposure the iris of the animals was reddened and the cornea showed a diffuse opacity. 48 hours post-exposure an obvious hyperaemia of some vasculature of the conjunctiva and a diffuse carmine red colour of the conjunctiva were observed respectively. Two animals showed a slight swelling of the conjunctiva. Still at 72 hours post-exposure a marked hyperaemia of some vasculature of the conjunctiva was observed on two animals. The appearance of the irritation was accompanied by a clear, colourless discharge. All irritation symptoms were reversible 7 days after the exposure.

In relation to the the present study the 4-chloroaniline is consequently evaluated als slight irritant. However, according to the classification criteria of the guideline 83/467/EWG and of the regulation for hazardous substances no labeling is required for 4-chloroaniline.