Hydrogen [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

EC Number:

287-257-4

EC Name:

Hydrogen [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Cas Number:

85443-67-0

Molecular formula:

C16 H11 Cr N5 O8 S .C11 H25 N O .H

IUPAC Name:

1-Propanamine, 3-[(2-ethylhexyl)oxy]-,(T-4)-[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]hydroxychromate(1-)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: About 3-4 months
- Weight at study initiation: 2.56 - 2.69 kg
- Housing: Singly housing in stainless steel wire mesh cages with grating, floor area: 3000 cm².
- Diet: standardized animal laboratory diet (about 130 g/animal/day)
- Water: ad libitum
- Acclimation period: At least 5 days before the beginning of the study.

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

0.1 mL bulk volume (about 25 mg of the comminuted test substance)

Duration of treatment / exposure:

1 hour

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

Body weight determination just before application of the test substance and after the last reading.
The test substance was applied in a single dose to the conjunctival sac of the right eyelid.
About 1 hour after application of the solid test substance the treated eye of the animals was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
Readings approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28.
Check for dead or moribund animals: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
The evaluation of eye irritation is performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

Slight to moderate conjunctival redness, slight conjunctival chemosis and slight to moderate discharge were observed during the course of the study. In addition injected scleral vessels in a circumscribed area were noted during the study period.

Any other information on results incl. tables

INDIVIDUAL OCULAR EXAMINATIONS AND MEAN VALUES

Readings	Animal	Cornea		Iris	Conjunctiva			Additional findings
		Opacity	Area of cornea involved		Redness	Chemosis	Discharge
1 h	01	0	0	0	1	1	1	*
	02	0	0	0	2	1	1	*
	03	0	0	0	2	1	2	*
24 h	01	0	0	0	1	0	0	*
	02	0	0	0	1	0	0	*
	03	0	0	0	1	0	0	*
48 h	01	0	0	0	0	0	0	*
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
72 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
Mean 24-  72 h	01	0.0		0.0	0.3	0.0
	02	0.0		0.0	0.3	0.0
	03	0.0		0.0	0.3	0.0
Mean		0.0		0.0	0.3	0.0

* Scleral vessels injected, circumscribed area

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 25 mg) of the test substance to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals) . About 1 hour after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Slight to moderate conjunctival redness, slight conjunctival chemosis and slight to moderate discharge were observed during the course of the study. In addition injected scleral vessels in a circumscribed area were noted during the study period. The ocular reactions were reversible in all animals within 72 hours after application at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and for chemosis and 0.3 for conjunctival redness. Considering the described ocular reactions as well as the average score for irritation, the test item does not show an eye irritation potential under the test conditions chosen.