N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 05 October, 1993 to 22 October, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

EC Number:

201-369-2

EC Name:

N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

Cas Number:

81-68-5

Molecular formula:

C22H18N2O5S

IUPAC Name:

N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 36034/E
- Substance type: Dye
- Physical state: Solid; dark violet powder
- Analytical purity: Approx. 93 %
- Lot/batch No.: 9300102
- Storage condition of test material: Room temperature
-Validity: July, 1998
-Test substance received: September 13, 1993

Specific details on test material used for the study:

Test material: FAT 36034/E
Batch No.: 9300102
Expiry date: July, 1998
Purity: 93 %
Solubility: in water <0.1 g/L
Colour: red
Storage: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2420 to 2630 g
- Housing: The animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Standard rabbit pellet – Nafag No. 814, Gossau, Switzerland (ad libitum)
- Water (e.g. ad libitum): Fresh water (ad libitum)
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C.
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the second eye of the treated animals served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL (i.e., 47 mg)
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Duration of treatment same as observation period.

Observation period (in vivo):

72 h after the treatment

Number of animals or in vitro replicates:

3 males

Details on study design:

- 0.1 mL (i.e., 47 mg) of test substance was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test substance.
-The right eye remained untreated and was used as untreated control.
-The ocular reaction were evaluated 1, 24, 48, and 72 h after instillation of test substance with the aid of slit-lamp

SCORING SYSTEM:
The ocular reactions were according to the OECD scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

The eye reactions observed were reversed by Day 2.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 36034/E is not irritating to the eyes.

Executive summary:

An in vivo study was conducted to evaluate the acute eye irritation potential of the test substance (of ca. 93 % purity) in rabbits according to OECD Guideline 405 and EU method B5 in compliance with GLP. 0.1 mL (47 mg) of the test substance was placed into the conjunctival sac of the left eye of three male rabbits without rinsing. The right eye remained untreated and was used for control purposes. Observation were made at 1, 24, 48 and 72 h following treatment. The corneal or iridial effects were reversible within 24 h. Conjunctival irritation was observed in all the treated animals which was reversible within the observation period of 72 h. Under the study conditions, the test substance does not need to be classified as irritating to the eyes.