Tetrasodium tripotassium (.my.-((2,2'-((3-imino-6-sulfonatophenyl-(N-methyl)-imino)bis((6-chloro-1,3,5-triazin-4,2-diyl)imino(2-hydroxy-5-sulfonato-3,1-phenylen)azo(phenylmethylen)azo))bis(4-sulfonatobenzoato))-dicuprate(7-)

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:

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

406-077-0

EC Name:

-

Molecular formula:

Hill formula: C53H29Cl2Cu2K3N18Na4O21S5

IUPAC Name:

dicopper(2+) tripotassium tetrasodium 2-{[({2-[3-({4-[(3-{[4-({3-[({[2-(2-carboxylato-5-sulfonatophenyl)diazen-1-yl](phenyl)methylidene}amino)azanidyl]-2-oxido-5-sulfonatophenyl}amino)-6-chloro-1,3,5-triazin-2-yl](methyl)amino}-4-sulfonatophenyl)amino]-6-chloro-1,3,5-triazin-2-yl}amino)-2-oxido-5-sulfonatophenyl]hydrazin-2-id-1-ylidene}(phenyl)methyl)imino]amino}-4-sulfonatobenzoate

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: male: 2.3 kg; females: 2.41 and 2.48 kg
- Housing: single
- Diet: Kliba 341, 4 mm; Klingentalmühle AG, Switzerland; ca. 130 g/animal/day
- Water: 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):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12. Feb. 1990 To: 27. Feb 1990

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL bulk volume (about 69 mg of the comminuted test substance)

Duration of treatment / exposure:

24 h

Observation period (in vivo):

15 d. Readings: 1h, 24h, 48h, 72h, 8d, 15d. A check for mortality was made twice each workday and once on Saturday, Sunday or public holidays.

Number of animals or in vitro replicates:

3 ( 1 male and 2 females)

Details on study design:

The test substance was applied in a single dose to the conjunctival sac of the right eyelid. The substance was not washed out.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 15 d

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 8 d

Remarks on result:

probability of weak irritation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the study conditions, the test substance caused irritation to the conjunctiva of 2 rabbits with a score >= 2. All effects were reversible within the 15 days observation period

Executive summary:

A study was conducted to determine the eye irritation/corrosion potential of the test substance in White Vienna rabbits according to OECD Guideline 405 and EU Method B.5, in compliance with GLP.

0.1 mL of the test substance (about 69 mg) was applied in a single dose to the conjunctival sac of the right eyelid of each animal. The substance was not washed out. The untreated eye served as negative control. Readings were taken at 1, 24, 48, 72h, then 8 and 15 d. The average score (24, 48, 72 h) for irritation was calculated to be 0.0 for corneal opacity and iris. The index for chemosis was 1.33 in all three rabbits; conjunctival redness was 2.33 in 2 animals and 1.33 in one rabbit. The findings were reversible in all animals within 8 or 15, days of application. Under the study conditions, the test substance caused conjunctival reddening in 2 rabbits with a score of >=2 and has hence to be classified as irritating to eyes.