trisodium 4-hydroxy-6-(sulfonatomethylamino)-5-(2-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2-sulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 19, 1998 to January 22, 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

430-280-3

EC Name:

-

Cas Number:

844491-96-9

Molecular formula:

Hill formula: C19H16N3Na3O13S4

IUPAC Name:

lithium(1+) disodium 4-hydroxy-6-[(sulfonatomethyl)amino]-5-(2-{2-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate

Test material form:

solid

Remarks:

black-brown

Details on test material:

Reactive Red 1997

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

Chbb: NZW (SPF)

Details on test animals or tissues and environmental conditions:

Source: Boehringer Ingelheim Pharma KG, Birkendorferstrasse 65, D-88397 Biberach/Riss
Number of animals: 1 male, 2 females
Age at start of treatment: 15 weeks
Identification: by unique cage number and corresponding ear number
Acclimatization: Four days under test conditions after health examination.
Room temperature/ relative humidity: air conditioned with 10-15 air changes per hour, with target ranges for room temperature 20 ±3 °C and of 40 – 70 % humidity.
Day/night rhythm: 12h/ 12h
Type of cage: single, stainless steel wire mesh cages with automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
Bedding: no bedding in the cages, wood shavings in the waste trays
Diet: Pelleted standard Kliba-3410 rabbit maintenance diet ad libitum
Water: tap water, from Itingen, ad libitum in water bowls

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

The eyes of the animals were examined one day prior to test article administration. On the day of the treatment the test substance (undiluted) 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 substance. The right eye remained untreated and served as the reference control. The treatment eyes were rinsed gently with physiological saline approximately 24 hours after administration.

Observations
Mortality/ viability: daily
Clinical signs: daily during the observation period
Body weights: a start of acclimatization, on the first day of application and at termination of observation

The ocular reaction was assessed according to the numerical according system listed in EEC Commission Directive 92/69/EEC, 1992 at approximately 1, 24, 48 and 72 hours after administration.

Pathology
No necropsy was performed in the animals sacrificed at termination of observation. All rabbits were sacrifices by an intravenous injection of Narcoren into the ear vein of at least 1 ml/kg body weight.

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:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Application of the test substance to healthy intact rabbit conjunctivae resulted in a primary irritation score of 0.00. Slight swelling of the conjunctivae and moderate watery discharge were noted in all animals once hour after application. All signs of irritation were reversible after 24 hours.
Reversible light violet staining of the sclera and conjunctivae by the test substance was observed. The corneas were not affected. No corrosion of the cornea was observed atany of the reading times.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
The body weight of all rabbits was considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the test substance was considered to be non-irritant to the rabbit eye.

Executive summary:

A study was conducted to determine the potential of the test substance to cause damage to conjunctiva, cornea or iris after a single exposure of about 24 h according to OECD 405 Guideline and EU Method B.5, in compliance with GLP. The primary irritation potential was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits. The treated eyes were rinsed gently with physiological saline approximately 24 h after administration. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 h after test substance application. The scores of each animal at 24, 48 and 72 h 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 h and then dividing the resulting total by the number of data points. The primary irritation score was 0.00 (max. 13). Swelling of the conjunctivae and watery discharge were noted at all animals 1 h after application. All signs of irritation were reversible after 24 h. Reversible light violet staining of the sclera and conjunctivae by the test substance was observed. The corneas were not affected. No corrosion was observed at any of the measuring intervals. Under the study conditions, the test substance was considered to be non-irritant to the rabbit eye (Braun, 1998).