Cuprate(4-), [.mu.-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-.kappa.O)-4,1-phenylene]-2,1-diazenediyl-.kappa.N1]]bis[4-(hydroxy-.kappa.O)-2,7-naphthalenedisulfonato]](8-)]]di-, ammonium sodium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-03-19 and 1980-05-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: according to the guideline of the United States Environmental Protection Agency (EPA)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Version / remarks:

1978

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

FAT 11181/A

IUPAC Name:

FAT 11181/A

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 to 3 kgs
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2
- Humidity (%): 55 + 10
- Photoperiod: 10 hours light cycle day

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g

Duration of treatment / exposure:

The lids were gently closed togehter for a few seconds.

Observation period (in vivo):

24 h/ 48 h/ 72 h/ 4 d/ 7 d

Number of animals or in vitro replicates:

6 (3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: In 3 of 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.

SCORING SYSTEM: according to the EPA score system

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 h/ 48 h/ 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24 h/ 48 h/ 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 h/ 48 h/ 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24 h/ 48 h/ 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Any other information on results incl. tables

The cornea, iris, redness and chemosis scores of animals which received a washout are given in the following table.

Irritation parameter	Basis	Time point	Score	Max. score	Reversibility
Cornea score	Animal 4	24 h/ 48 h/ 72 h	0	4
	Animal 5		0
	Animal 6		0
Iris score	Animal 4	24 h/ 48 h/ 72 h	0	2
	Animal 5		0
	Animal 6		0
conjunctivae score	Animal 4	24 h/ 48 h/ 72 h	1	3	Fully reversible within 7 days
	Animal 5		0.66		Fully reversible within 72 h
	Animal 6		0.66		Fully reversible within 72 h
chemosis score	Animal 4	24 h/ 48 h/ 72 h	0.66	4	Fully reversible within 72 h
	Animal 5		0.66
	Animal 6		0.66

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU