Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: 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:

observation period of 8 days, limited data to test substance, source/breeder not mentioned, ages of animals not documented, read across substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Fed. Reg. 38, No. 187, § 1500.42, p. 27019, Sept. 27, 1973

Principles of method if other than guideline:

Draize Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate

EC Number:

265-634-4

EC Name:

Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate

Cas Number:

65212-77-3

Molecular formula:

C16H12Cl2N4O7S2.Ca

IUPAC Name:

calcium 4,5-dichloro-2-{[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

No. of animais per cage: 1
Room temperature: 20 - 26°C
Humidity: Conventional (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Diet: Ovator Solikanin 4 mm; Muskator-Werke, Düsseldorf, FRG (about 130 g per animal per day)
Drinking water: About 250 ml per animal per day: demineralized water (Monday - Friday), tap water (Saturday/Sunday).
Acclimatization period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study.
Mean weight (kg) males 2.99, females 2.57

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

0.1 ml bulk volume (about 31 mg of the comminuted test substance)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

6

Details on study design:

Appl. site: Conjunctival sac of the right eyelid
Assessment: Based on J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health.
Readings: 1 h, 24 h, 48 h, 72 h, 8 d after application
Single application to the conjunctival sac of the eyelid; the substance is not washed out

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 h

Score:

1.17

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 8d

Score:

0.3

Max. score:

3

Reversibility:

not fully reversible within: 8d

Remarks on result:

other: shows tendency to nomalize within 21d

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 8 days

Other effects:

Discharge was observed in three animals at reading 24 h (score 1), in two animals at reading 48 h (score 1) and in one animal at reading 72h (score 1). This was reversible within 8 days.

Any other information on results incl. tables

Table 1: Irritation results

Animal	Reading	Cornea Opacity	Iris	Conjunctiva		Additional findings
				Redness	Chemosis
1	24 h	0	0	1	0	-
2	24 h	0	0	2	1	-
3	24 h	0	0	1	0	-
4	24 h	0	0	2	1	-
5	24 h	0	0	1	0	-
6	24 h	0	0	2	1	-
1	48 h	0	0	1	0	-
2	48 h	0	0	1	1	-
3	48 h	0	0	1	0	-
4	48 h	0	0	1	0	-
5	48 h	0	0	1	0	-
6	48 h	0	0	2	1	-
1	72 h	0	0	1	0	-
2	72 h	0	0	0	0	-
3	72 h	0	0	0	0	-
4	72 h	0	0	1	0	-
5	72 h	0	0	1	0	-
6	72 h	0	0	2	1	-
1	8 d	0	0	0	0	-
2	8 d	0	0	0	0	-
3	8 d	0	0	0	0	-
4	8 d	0	0	1	0	-
5	8 d	0	0	0	0	-
6	8 d	0	0	1	0	-
mean animal 1	24 - 72 h	0.00	0.00	1.00	0.00
mean animal 2	24 - 72 h	0.00	0.00	1.00	0.67
mean animal 3	24 - 72 h	0.00	0.00	0.67	0.00
mean animal 4	24 - 72 h	0.00	0.00	1.33	0.33
mean animal 5	24 - 72 h	0.00	0.00	1.00	0.00
mean animal 6	24 - 72 h	0.00	0.00	2.00	1.00
mean	24 - 72 h total	0.00	0.00	1.17	0.33

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met