Benzenesulfonic acid, 2-amino-4,5-dichloro-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study without GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-4,5-dichlorobenzene-1-sulfonic acid

EC Number:

700-413-2

Cas Number:

6331-96-0

Molecular formula:

C6 H5 Cl2 N O3 S

IUPAC Name:

2-amino-4,5-dichlorobenzene-1-sulfonic acid

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/ Main, Frg.
- Age at study initiation: no data.
- Average weight at study initiation: 2.97 kg
- Housing: Individual caging in stainless steel cages with wire mesh walk floors; floor area = 40 cm x 51 cm.
- Diet: Kliba 341, 4 mm; Klingenthalmuehle AG, CH-4303 Kaiseraugst, Switzerland; ad libitum (ca. 130 g/animal/day).
- Water: ad libitum (ca. 250 mL tap water/animal/day).
- Acclimation period: at least 8 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24.
- Humidity (%): 30-70.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye (untreated).

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml (ca. 28 mg of the comminuted test substance).

Duration of treatment / exposure:

After application, eyes were not washed.

Observation period (in vivo):

72 hours
- readings were performed 30-60 min after removal of the test patches, as well as 24, 48 and 72 hours after the start of exposure.

Number of animals or in vitro replicates:

3 (males).

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: OECD scoring system

TOOL USED TO ASSESS SCORE: no data.

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:

1.3

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable.

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours.

Score:

0

Max. score:

4

Reversibility:

other: not applicable.

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

(3 animals)

Time point:

other: 24, 48 and 72 hours.

Score:

0

Max. score:

2

Reversibility:

other: not applicable.

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

1.7

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours.

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 10

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: 48 hours.

Other effects:

- Loss of corneal tissue: seen in animal # 3 (5 hours after start of application), animal # 1 (24 and 48 hours after start of application). This effect was fully reversible 72 hours after start of exposure.

- Retractions of the eyelid: seen in animal # 2 (24 and 48 hours after start of application). This effect was fully reversible 72 hours after start of exposure.

Any other information on results incl. tables

Table 1: Table of results (Individual scores and means).

Readings	Animal	Cornea opacity	Iris	Conjunctivae		Symptoms
				Redness	Chemosis
1 h	1	0	0	2	2
	2	0	0	2	2
	3	1	0	2	2	L
24 h	1	2	0	2	1	L
	2	0	0	2	1	R
	3	0	0	2	1
48 h	1	2	0	2	0	L
	2	0	0	2	0	R
	3	0	0	1	0
72 h	1	0	0	1	0
	2	0	0	0	0
	3	0	0	0	0
mean	1	1.3	0	1.7	0.3
	2	0	0	1.3	0.3
	3	0	0	1.0	0.3

 

L = Loss of corneal tissue

R = Small retractions in the eyelids

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information