Reaction mass of Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)Vinyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)]-, sodium and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[2-(sulfooxy)Ethanol]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt

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 July 5 to 8,1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Complete read across justification is attached in section 13. Source study has reliability 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

RA Substance 01

IUPAC Name:

RA Substance 01

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG
- Weight at study initiation: 2.8 - 3.6 kg
- Housing: in a climatised room, inside a standard cage
- Diet : Altromin 2013 Zuchtdiat, ad libitum
- Water : deionized water with chloride, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hrs cycle dark/light

Test system

Vehicle:

physiological saline

Remarks:

to form a paste

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL: 100 mg.

VEHICLE: 0.01 ml physiological saline.

Duration of treatment / exposure:

24 hours.

Observation period (in vivo):

72 hours.

Number of animals or in vitro replicates:

3.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing : yes, with warm physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize
CORNEA
Degree of turbidity (reading in the area of ​​the strongest turbidity)
0 No turbidity, no ulceration
1* Turbidity on individual scattered districts, details of the iris clearly visible
2* Easily recognizable translucent regions of turbidity, details of iris slightly darkened
3* Turbidity of pearly-like appearance, no details of the iris can be seen, size of the pupil barely visible
4* Complete corneal opacity, iris not visible
IRIS
1* Conspicuously deep retracted folds, hyperemia, swelling, circumcorneal vascular symptoms (one of these symptoms or combinations of them), iris still responds to light (slow response = positive)
2* No reaction to light, bleeding, destruction of iris (some or all symptoms)
CONJUNCTIVA
redness
0 Vessels normal
1 Vessels clearly injected (hyperemia)
2* Diffuse ruby ​​redness, single vessels not easy to distinguish
3* Diffuse fleshy redness
chemosis
0 No swelling
1 Slight swelling (including throat)
2* Distinct swelling, partial lifting of the lid
3* Swelling, with eyelids half-closed
4* Swelling, eyelids being closed more than half to full

* means positive effect

TOOL USED TO ASSESS SCORE: UV-light, fluorescein (0.01 %) and slit-lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no ocular effect observed

Results 2

Irritation parameter:

iris score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no ocular effects observed

Results 3

Irritation parameter:

chemosis score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no ocular effects observed

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no ocular effects observed

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

The conjunctiva at 1 h was blue discoloured.

Any other information on results incl. tables

time post-application	animal	cornea opacity	iris	conjuctivae redness	conjunctivae chemosis
1 h	1	0	0	1	1
	2	0	0	0	1
	3	0	0	1	1
24 h	1	0	0	0	0
	2	0	0	1	0
	3	0	0	1	0
48 h	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0
72 h	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

The substance is considered as not irritant to the eye of rabbits.

Executive summary:

Method

Test substance was applied to rabbit eye according to OECD guideline 405. After 24 h exposure, observations were done at 1, 24, 48 and 72 h after eye rinse.

Results

2 of 3 rabbits showed vessels clearly injected (hyperemia) 24 h after eye rinse. However, such effects were reversible within 48 hours. Consequently, test substance was considered as non irritant to rabbit eyes.