[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read across from similar substance

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Remarks:

Department of Toxicology, BASF AG

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)

EC Number:

260-906-9

EC Name:

Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)

Cas Number:

57693-14-8

Molecular formula:

C40H20CrN6O14S2.3Na

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG
- Weight at study initiation: mean 2.76 kg (males), 2.87 kg (females)
- Housing: individually in cages made of stainless steel with wire mesh walk floors (floor area 40 cm x 51 cm)
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm (Muskator-Werke D-4000 Düsseldorf 1, FRG; about 130 g per animal per day)
- Water (e.g. ad libitum): tap water (about 250 ml per animal per day )
- Acclimation period: at least 8 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 90 mg) of the ground test substance

Duration of treatment / exposure:

single application

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3 (2 females, 1 male)

Details on study design:

SCORING SYSTEM:

Cornea
(A) Opacity-degree of density (area most dense taken for reading)
0 = No opacity
1 = Scattered or diffuse area, details of iris clearly visible
2 = Easily discernible translucent areas, details of iris slightly obscured
3 = Opalescent areas, no details of iris visible, size of pupil barely discernible
4 = Opaque, iris invisible

(B) Area of cornea involved
1 = One quarter (or less) but not zero
2 = Greater than one quarter, but less than half
3 = Greater than half, but less than three quarters
4 = Greater than three quarters, up to whole area

Iris
(A) Values
0 = Normal
1 = Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination af any thereof) iris still reacting to light (sluggish reactions is positive)
2 = No reaction to light, hemorrhage, gross destruction (any or all of these)

Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0 = Vessels normal
1 = Vessels definitely injected above normal
2 = More diffuse, deeper crimson red, individual vessels not easily discernible
3 = Diffuse beefy red

(B) Chemesis
0 = No swelling
1 = Any swelling above normal (includes nictitatinq membrane)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids about half closed to completely closed

(C) Discharge
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: mean, 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: no readable effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean 24, 48, 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean 24, 48, 72 h

Score:

1.2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Any other information on results incl. tables

Animal 1: female, 2.95 kg

Animal 2: female, 2.78 kg

Animal 3: male, 2.76 kg

Readings:

Readings	Animal	cornea		Iris	conjunctiva			Symptons
		opacity	area		redness	swelling	discharge
1 h	1	0	0	0	0**	2	2	s
	2	0	0	0*	0**	2	2	s
	3	0	0	0*	0**	2	2	s
24 h	1	0	0	0	2	2	1
	2	0	0	0*	2	2	1	s
	3	0	0	0*	2	2	1	s
48 h	4	0	0	0	1	1	0
	5	0	0	0	1	1	0
	6	0	0	0	1	1	0
72 h	1	0	0	0	1	0	0
	2	0	0	0	1	1	0
	3	0	0	0	1	1	1
8 d	1	0	0	0	0	0	0
	2	0	0	0	0	0	0
	3	0	0	0	0	0	0
mean 24 - 72 h	1	0		0	1.3	1.0
	2	0		0	1.3	1.3
	3	0		0	1.3	1.3
Mean		0		0	1.3	1.2

s: irritation index could not be read because of staining due to the color of the test substance

*: if in 1 or 2 animals assessments referring to the same characteristic cannot be made at a particular reading, the mean rounded to the nearest whole number of the values that can be read is inserted instead

**: if in all animals assessments referring to the same CO characteristic cannot be made at a particular reading, zero is inserted instead

Applicant's summary and conclusion

Interpretation of results:

other: not classified under Regulation 1272/2008