Disodium 5-[[2,4-dihydroxy-5-[(4-nitrophenyl)azo]phenyl]azo]-4-hydroxy-3-[(2-hydroxy-3,5-dinitrophenyl)azo]naphthalene-2,7-disulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ETAD Toxicological Methods n° 3

Deviations:

not specified

Principles of method if other than guideline:

Six rabbits are tested with test substance directly injected. The recovery period was 7 days.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 5-[[2,4-dihydroxy-5-[(4-nitrophenyl)azo]phenyl]azo]-4-hydroxy-3-[(2-hydroxy-3,5-dinitrophenyl)azo]naphthalene-2,7-disulphonate

EC Number:

268-975-7

EC Name:

Disodium 5-[[2,4-dihydroxy-5-[(4-nitrophenyl)azo]phenyl]azo]-4-hydroxy-3-[(2-hydroxy-3,5-dinitrophenyl)azo]naphthalene-2,7-disulphonate

Cas Number:

68155-63-5

Molecular formula:

C28H15N9Na2O16S2

IUPAC Name:

disodium 5-[[2,4-dihydroxy-5-[(4-nitrophenyl)azo]phenyl]azo]-4-hydroxy-3-[(2-hydroxy-3,5-dinitrophenyl)azo]naphthalene-2,7-disulphonate

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

not specified

Duration of treatment / exposure:

Single injection

Observation period (in vivo):

24, 48, 72 hours and 7 days

Details on study design:

REMOVAL OF TEST SUBSTANCE
-Washing: yes

SCORING SYSTEM:
CORNEA
-Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly
visible: 1
Easily discernible translucent area, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
-Area of cornea affected
No ulceration or opacity: 0
One quarter or less but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
IRIS
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection,
any of these or any combination thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
CONJUNCTIVAE
-Redness: (refers to palpebral and bulbar conjunctivae, excluding cornea and iris).
Blood vessels normal
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
-Chemosis: lids and/or nictating membrane
No swelling: 0
Any swelling above normal (includes nictating membrana): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
-Discharge:
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus of
normal animals): 1
Discharge with moistening of the lids and hairs, just adjacent to lids: 2
Discharge with moistening of the lids and hairs, in a considerable area around the eye: 3.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Irritant / corrosive response data:

The substance causes no signs of irritation for rinsed eye on test animals.
The unrinsed eye shows slight redness in all tested animals, swelling in 4 rabbits, and for 2 rabbits were found slightly inflammation on Iris.
On the 7th day all animals were found without signs of irritation.

Applicant's summary and conclusion

Interpretation of results:

other: Not classifed according to the CLP classification (EC 1272/2008)

Conclusions:

The test substance was found to be not irritating to the rabbit eye under the test condition.

Executive summary:

The substance was tested for eye irritation according to the ETAD method No. 3. Six rabbits were treated with test substance directly injected into the conjunctival sac. One eye was rinsed, the other eye remain unrinsed. During the observation period no signs of irritation was found into the rinsed eyes.

The test substance was found to be not irritating to the rabbit eye under the test condition.