Sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-11-09 to 1982-11-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

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:

Sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate

EC Number:

273-402-9

EC Name:

Sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate

Cas Number:

68959-19-3

Molecular formula:

C17H16Cl2N4O5S2.Na

IUPAC Name:

sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: average weight of 2.5 kg
- Housing: individually in cages
- Diet (e.g. ad libitum): diet “mümmel z" (ssniff / Soest); ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single treatment, the treated eye was not washed

Observation period (in vivo):

Scoring was conducted after 1, 24, 48, 72 hours and 8 days after treatment

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize (see Table 1 in box "Any other information on materials and methods incl. tables")

TOOL USED TO ASSESS SCORE: ophthalmoscope, fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0.56

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0.22

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

probability of moderate irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

All symptoms were fully reversible within 8 days. For individual results see Table 2 in box "Any other information on results incl. tables". In 2 of 3 animals a positive response of conjunctival redness is ≥ 2 which leads to a classification of Eye Irrit. (Cat. 2) according to CLP criteria.

Any other information on results incl. tables

Table 2: Individual Eye Irritation Scores

	24 hours				48 hours				72 hours				8 days				Mean (24,48 and 72 hours)
Animal no.	Cornea	Iris	Conjunctivae	Chemosis	Cornea	Iris	Conjunctivae	Chemosis	Cornea	Iris	Conjunctivae	Chemosis	Cornea	Iris	Conjunctivae	Chemosis	Cornea	Iris	Conjunctivae	Chemosis
1	1	1	3	2	1	1	3	2	1	0	2	1	0	0	0	0	1	0,67	2,67	1,67
2	1	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0,3	0	0,3	0,3
3	1	0	2	1	0	0	2	1	0	0	2	1	0	0	0	0	0,3	0	2	1

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In an acute eye irritation/corrosion study in rabbits 2 of 3 animals showed irritanting effects on the conjunctivae, which were fully reversible within 8 days.

Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of the test item was instilled into the conjunctival sac of the right eye of three young adult New Zealand White rabbits. Animals then were observed for 8 days. Irritation was scored by the method of Draize. In 2 of 3 animals, the irritation score of conjunctivae redness was ≥ 2. Irritation on cornea and conjunctivae chemosis have been also observed. All symptoms were fully reversible within 8 days. In this study, the test item is an eye irritant and according to CLP criteria classification as Eye Irrit. 2 (H319) is warranted.