Sodium 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonate

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No 21-day observation period. Details on the read across are reported in section 13. Source study has reliability 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 049 acid

IUPAC Name:

Acid Yellow 049 acid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Spolkem chovatelů z Hradce Králové.
- Weight at study initiation: 2.5 kg.
- Housing: housed individually in metal cages.
- Diet: pelleted standard commercially manufactured compound KO-16, supplied by s.p. Velaz Prague.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 50 ± 15 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g
- Application: the substance was introduced in conjunctival sac. The upper and lower lids were maintained closed for few seconds, to avoid loss of the test substance.

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with drinking water.
- Time after start of exposure: 24 hours.

SCORING SYSTEM:
The reactions observation was performed at 1, 24, 48 and 72 after substance application. 1 hour after the instillation of ocular reactions were assessed without flushing of the eye with drinking water. Reaction at 48 hours were scored without the usage of fluorescein.

TOOL USED TO ASSESS SCORE: fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Animal no.	Time score (hrs)	Cornea		Iris	Conjunctival
		Opacity	Area		Redness	Chemosis	Discharge
22	1	0	0	0	1	0	2
	24	0	0	0	0	0	1
	48	0	0	0	0	0	0
	72	0	0	0	0	0	0
28	1	0	0	0	1	0	1
	24	0	0	0	1	0	0
	48	0	0	0	1	0	0
	72	0	0	0	0	0	0
29	1	0	0	0	2	0	1
	24	0	0	0	1	0	0
	48	0	0	0	1	0	0
	72	0	0	0	1	0	0

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Not irritating to rabbit eye.

Executive summary:

Method

The eye irritation potential of the substance was determined following OECD guideline 405. 0.1 g of test substance were placed into conjunctival sac of three rabbits. After 24 hours of exposure the substance was removed using drinking water.

Result

The primary irritation score was 2.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all animals.