1-amino-4-hydroxy-2-phenoxyanthraquinone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 2nd, 1980 to June 9th, 1980

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Red 060

IUPAC Name:

Disperse Red 060

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: New Zealand White breed
- Weight at study initiation: 2 - 3 kg
- Housing: individual housing in metal cages
- Diet (e.g. ad libitum): standard rabbit food, NAFAG, no. 814, Gossau SG
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: 4 days minimum
- Other: Only rabbits showing normal ophthalmic findings were included in the test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

1, 2, 3, 4 and 7 days

Number of animals or in vitro replicates:

6 animals: 3 males and 3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits (animals n. 22, 23 and 24) were each flushed with 10 ml physiological saline approximately 30 seconds after treatment

TOOL USED TO ASSESS SCORE:
- The reactions were appraised with a slit-lamp after 1, 2, 3, 4 and 7 days

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 6/6

Time point:

other: mean 24, 48 and 72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: No ocular effect oserved

Results 2

Irritation parameter:

iris score

Basis:

animal: 6/6

Time point:

other: mean 24, 48 and 72 h

Score:

ca. 0

Max. score:

2

Reversibility:

other: No ocular effect oserved

Results 3

Irritation parameter:

other: conjunctivae score (redness and chemosis)

Basis:

animal: 6/6

Time point:

other: mean 24, 48 and 2 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: No ocular effect oserved

Any other information on results incl. tables

RABBIT EYE IRRITATION SCORES

n = not rinsed      

r = rinsed

p = purulent

Time point	24 hours						48 hours						72 hours
Rabbit no.	19	20	21	22	23	24	19	20	21	22	23	24	19	20	21	22	23	24
Eye	n	n	n	r	r	r	n	n	n	r	r	r	n	n	n	r	r	r
I. Cornea   A Opacity B Area involved   a = A × B × 5 (max. 80)	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0
II. Iris   b = Score × 5 (max. 10)	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
III. Conjunctiva   A Redness B Chemosis C Discharge   c = A + B + C × 2 (max. 20)	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0
Total = a + b + c (max. 110)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Group mean	0			0			0			0			0			0

Time point	4 days						7 days
Rabbit no.	19	20	21	22	23	24	19	20	21	22	23	24
Eye	n	n	n	r	r	r	n	n	n	r	r	r
I. Cornea   A Opacity B Area involved   a = A × B × 5 (max. 80)	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0	0 0   0
II. Iris   b = Score × 5 (max. 10)	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
III. Conjunctiva   A Redness B Chemosis C Discharge   c = A + B + C × 2 (max. 20)	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0	0 0 0   0
Total = a + b + c (max. 110)	0	0	0	0	0	0	0	0	0	0	0	0
Group mean	0			0			0			0

EFFECT OF RINSING

Primary irritation index in unrinsed eyes, A = 0

Primary irritation index in rinsed eyes, B = 0

Effect of rinsing, R = A/B = 0/0

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Non-eye irritant.

Executive summary:

The eye irritation potential of the test substance was examined by the slit-lamp procedure on the basis of the US EPA guideline 163.81–4 "Primary Eye Irritation," Federal Register, Vol 43, No. 163, August 22, 1978.

0.1 g of unchanged test substance was applied to the left eye of 3 male and 3 female New Zealand white rabbits for 30 seconds. The untreated right eye served as controls. Treated eyes of three rabbits were each flushed with 10 ml physiological saline approximately 30 seconds after treatment. Eye reactions were scored at 24 h, 48 h, 72 h, 4 d and 7 d after exposure.

The mean irritation indexes (at 24, 48 and 72 h) for 6/6 animals were as follows: Cornea = 0, Iris = 0 and Conjunctivae = 0.

Therefore, the test substance is considered as non-eye irritant.