Iron, complexes with diazotized 5-amino-2-(phenylamino)benzenesulfonic acid monosodium salt coupled with 4-[(2-hydroxy-3,5-dinitrophenyl)azo]-1,3-benzenediol, diazotized 4-nitrobenzenamine and diazotized 3-aminobenzenesulfonic acid monosodium salt

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Food and Drug Administration of the U.S.A. Federal Register (17 September, 1964 § 191. 12)

Deviations:

yes

Remarks:

slight modification, no other description.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

AcidBrown311

IUPAC Name:

AcidBrown311

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 93 mg

Duration of treatment / exposure:

single injection

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: three rabbits eyes irrigated with 20 ml of lukeworm water (approx. 37 °C) 5 seconds after installation and three rabbits eye without rinsing

SCORING SYSTEM:
Cornea
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Complete corneal opacity, iris not discernible 4

Iris
Normal 0
Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any 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)
Vessels normal 0
Some vessels definitely injected 1
Diffuse, crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis
No swelling 0
Any swilling above normal (including nictating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 4#, #5 and #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Results 2

Irritation parameter:

iris score

Basis:

animal: #4, #5 and #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: #4 and #6

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: rinsed eye

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 4 days

Remarks on result:

other: rinsed eye

Results 5

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: rinsed eye

Results 6

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: rinsed eye

Results 7

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Conclusions:

The test material was found to cause no irritation when applied to the rabbit eye mucosa under the conditions of this experiment.

Executive summary:

The substance was evaluated for eye irritation/corrosion according to the "Food and Drug Administration of the U.S.A. Federal Register (17 September, 1964 § 191. 12)". Six rabbits were treated with test material directly injected, three eyes of rabbits were rinsed and three eyes remaining untreated. The mean values at 24/48/72 hour were calculated for the effects on the rinsed eye. The cornea and iris values were 0 in all animals. The conjunctivae redness were 0.67 in two animals (#4 and #6) and 1 in one animal (#5); chemosis were 0.67 (animal #4), 0.33 (animal #5) and 0 (animal #6). All effects observed were reversible within the study period. The effects on the not rinsed eye were comparable to the rinsed one and reversible within the study period.