Tetra(sodium/potassium)-7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chlor-6-({2-[(4-fluor-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]propyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalintrisulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 06 July 2006; Experiment completion date - 25 July 2006; Study completion date - 16 August 2006.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

black sticky powder, Purity: Content of organic part (Na-salt): approx. 80 %; Oligomers: 13 %; Main component: approx. 53 %; Stability of test item: Stable under storage conditions; Storage: At room temperature, desiccated and light protected.

Specific details on test material used for the study:

Identity: FAT 40827/A
Batch: T2 5572 BOP 01/06
Purity: determined in this study
Appearance: black sticky powder
Expiration date: 28.02.2011
Storage: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test System: Young Adult New Zealand White Rabbit (SPF)
Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 11-12 weeks (male); 13-14 weeks (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only healthy animals were used for the study.
Allocation: Male no. 7 and Female Nos: 8 – 9

Conditions
Standard Laboratory Conditions.
Air-conditioned with ranges for room temperature of 17 - 23 °C and relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations were considered not to have any influence on the study and, therefore, these data were not reported but were retained at RCC. 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Accommodation: Individually in stainless steel cages with feed hoppers, drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch 24/06) ad libitum.
Water: Community tap water, ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g per animal

Observation period (in vivo):

Viability/mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weight: At start of acclimatization, on the day of application and at termination of observation.
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application.

Number of animals or in vitro replicates:

3

Details on study design:

The eyes of the animals were examined one day prior to test item administration.
Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 0.1 g of test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation. The eyes of each animal were examined approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application.

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.44

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The instillation of test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 14 days after treatment, the end of the observation period for all animals. A slight black staining produced by the test item was visible in 2 animals 1 hour after application. The staining did not persist. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals.

Other effects:

No clinical signs were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item did not induce significant or damage to the rabbit eye.

Executive summary:

The primary eye irritation potential of test item was investigated according to OECD test guideline No.405. The test item was applied by instillation of 0.1g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual 24/48/72h mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 1.67 and 1.67 for reddening, respectively and 0.00 in all three animals for chemosis. The instillation of test item into the eye resulted in mild to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 14 days after treatment, the end of the observation period for all animals. A slight black staining produced by the test item was visible in 2 animals 1 hour after application. The staining did not persist. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No clinical signs were observed. Based on the result of this test, it indicates that the test item shall not be classified in accordance with CLP (Regulation EC 1272/2008).