reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-6-[(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From February 10 to March 08, 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The reliability of the source study is 1

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

July 31, 1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance

IUPAC Name:

Similar Substance

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne
- Age at study initiation: 15 weeks
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, qd libitum, in water bowls
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): fluorescent light on a 12 hour light/dark cycle
:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g (per animal) of the test article

Duration of treatment / exposure:

The substance was places into the conjunctival sac on the left eye and the eye was not rinsed

Observation period (in vivo):

1, 24, 48 and 72 hours, as well as 7, 14 and 21 days after administration

Number of animals or in vitro replicates:

1 male and 2 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

iris score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal:

Remarks:

all

Time point:

24/48/72 h

Score:

0

Other effects:

COLORATION
Blue staining of the nictitating membrane and the sclera by the test article was observed in all animals. Scleral staining persisted in two animals until 14 days after treatment and in one animal until 21 days. Light Staining of the nictitating membrane was evident in all animals until the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

other: Category 1 (irreversible effects on the eyes) based on GHS criteria

Conclusions:

Irreversible effects on the eye due to persistent staining

Executive summary:

The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits according to the OECD guideline 405. The treated eyes were not rinsed after application. 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. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary irritation score was 0.00 (max. 13). No signs of irritation were observed.
Blue staining of the nictitating membrane and the sclera by the test article was observed in all animals. Scleral staining persisted in two animals until 14 days after treatment and in one animal until 21 days. Light staining of the nictitating membrane was evident in all animals until the end of the observation period.
No corrosion was observed at any of the measuring intervals.