Disodium hydrogen bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

in vivo test. At the time of testing in-vitro test were not available

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study following official guidelines, GLP compliant, performed on a similar substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)

EC Number:

278-127-8

EC Name:

Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)

Molecular formula:

C40H22CrN4O10S2.H.2Na

IUPAC Name:

Trisodium bis[(E)-3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonate]chromate(3-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

The substance is the trisodium form of the target substance (disodium form)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: Interfauna UK Ltd Wyton, Huntingdon, England- Age at study initiation: adult- Weight at study initiation: the animals were weighed immediately before application of the test substance- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions. - Diet (e.g. ad libitum): Standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room-Identification of the animals: the rabbits were identified by individual ear marks (tattoos) and cage cardsENVIRONMENTAL CONDITIONS- Temperature (°C): 21+/-1.5°C- Humidity (%): 60-80%- Air changes (per hr):12-15 times per hour- Photoperiod (hrs dark / hrs light):from 6 am to 6 pm, 12 hours artifical illumination

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

pulverized

Controls:

other: the other eye served as control

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100ul (ca. 34 mg)

Duration of treatment / exposure:

24h

Observation period (in vivo):

1h, 24h, 48h, 72h, 7d, 14d, 21d

Number of animals or in vitro replicates:

3

Details on study design:

PROCEDURE:After gently pulling the lower lid away from the eyeball a volume of 100ul of the pulverised test substance-equivalent to approx. 34 mg- was placed into the conjunctival sac of one eye of each of three rabbits. The lids were than getnly held together for about on second in oirder to limit loss of the material. The other eye remained untreated and served as contro.l 24 hours after instillation of the test substance the treated eye was rinsed with normale saline.SCORING SYSTEM: for each animal the Draize scores (cornea, iris, conjunctivae, erythema and swelling and discharge) and the Mcdonald score (aqueous humor) were used. For each animal the Draize scores recorded approx. 24, 48 and 72h after application were added up. The total of these three values was divided by 3 to give the irritation index.TOOL USED TO ASSESS SCORE:optical instrument (hand slit lamp) and fluorescin.Only effects persisting for more than 24 hours were included in the evaluation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24,48 and 72h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24,48 and 72h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 24,48 and 72h

Score:

ca. 2

Max. score:

2

Reversibility:

not fully reversible within: 21d

Results 4

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

animal #1

Time point:

other: 24,48 and 72h

Score:

ca. 1.3

Max. score:

1

Reversibility:

not fully reversible within: 21d

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24,48 and 72h

Score:

ca. 1

Max. score:

1

Reversibility:

not reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24,48 and 72h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 21d

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: 24,48 and 72h

Score:

ca. 2

Max. score:

2

Reversibility:

not fully reversible within: 21d

Results 8

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

animal #2

Time point:

other: 24,48 and 72h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: 14d

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24,48 and 72h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 7d

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24,48 and 72h

Score:

ca. 0.7

Max. score:

1

Reversibility:

fully reversible within: 7d

Results 11

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: 24,48 and 72h

Score:

ca. 2

Max. score:

2

Reversibility:

fully reversible within: 7d

Results 12

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

animal #3

Time point:

other: 24,48 and 72h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: 7d

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The substance was tested for eye irritation following OECD 405 and resulted to be irritant to the eye with classification H319 Category 2A.

Executive summary:

The irritant/corrosive potential of the test substance was studied on the eye of rabbit in accordance with the OECD Guideline 405 for Testing of Chemicals. Exposure of the test substance to the eye caused reactions of the mucous membranes and effects of the cornea in all three animals. Additionally in all three animals the iris was transiently affected and discharge occured. In one animal signs was fully reversible within 21 days, in the second animal corneal signs did not prove to be completely reversible within 21 days and in the third animal a slight erythema was observed on day 21. This evidence indicates that the product may be considered as "severely irritating to the eye".