Reaction mass of Disodium dihydroxy[2-{[5-(hydroxy-kO)-3-methyl-1-(4-sulfophenyl)-1H-pyrazol-4-yl]diazenyl-kN1}benzoato(3-)-kO]chromate(2-) and Sodium hydroxy[2-{[5-(hydroxy-kO)-3-methyl-1-(4-sulfophenyl)-1H-pyrazol-4-yl]diazenyl-kN1}benzoato(3-)-kO]chromate(1-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium

EC Number:

276-702-8

EC Name:

[2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium

Cas Number:

72496-90-3

Molecular formula:

C17H11CrN4O6S

IUPAC Name:

[2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphophenyl)-1H-pyrazol-4-yl]azo]benzoato(3-)]chromium

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

None

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: housed individually in metal cages, numbered by ear tags
- Diet: standard rabbit food ad libitum - NAFAG, No. 814, Gossau SG
- Water: ad libitum


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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

The test material in an amount of 0.1 g was inserted

Duration of treatment / exposure:

The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.

Observation period (in vivo):

The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.

Duration of post- treatment incubation (in vitro):

None

Details on study design:

None

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:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

None

Other effects:

None

Any other information on results incl. tables

Table: Eye irritation – Individual scores

Animal No.	Rinsed/ not rinsed	Corneal opacity	Iris	Conjunctival redness	Chemosis
24 hours
200	not rinsed	0	0	0	2
201	not rinsed	0	0	0	1
202	not rinsed	0	0	0	0
203	rinsed	0	0	0	0
204	rinsed	0	0	0	0
205	rinsed	0	0	0	0
48 hours
200	not rinsed	0	0	0	1
201	not rinsed	0	0	0	0
202	not rinsed	0	0	0	0
203	rinsed	0	0	0	0
204	rinsed	0	0	0	0
205	rinsed	0	0	0	0
72 hours
200	not rinsed	0	0	0	0
201	not rinsed	0	0	0	0
202	not rinsed	0	0	0	0
203	rinsed	0	0	0	0
204	rinsed	0	0	0	0
205	rinsed	0	0	0	0
Day 7
200	not rinsed	0	0	0	0
201	not rinsed	0	0	0	0
202	not rinsed	0	0	0	0
203	rinsed	0	0	0	0
204	rinsed	0	0	0	0
205	rinsed	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20041/B can be considered as not an eye irritant.

Executive summary:

The eye irritation potential of the test substance was evaluated in a study conducted according to the proposed guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 3 male and 3 female adult New Zealand White rabbits. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. No irritation was seen when the exposed eyes were examined for corneal opacity, effects on iris and conjuntival redness. However mild chemosis was seen in 2 of 6 exposed animals, which was fully reversible within 72 hours. Hence, the scores obtained in this study do not fulfil the classification criteria for eye irritation as required by Regulation (EC) No. 1272/2008. Hence, FAT 20041/B can be considered as not an eye irritant.