Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)

EC Number:

280-068-8

EC Name:

Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)

Cas Number:

82933-90-2

Molecular formula:

C16H9ClCrN4O8S2.Na

IUPAC Name:

sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: average body weights of 2.73 kgs. (males) and 2.38 kgs. (females)
- Housing:The rabbits were caged singly in an experimental room.
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum.
- Water:Sterile filtered water was available at all times.
- Acclimation period: Six rabbits were acclimatised in the test area for one week prior to the start of the trial

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg.

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

Six rabbits (3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):After 30 seconds the compound was, as far as possible, flushed out of the eyes' of three of the rabbits with warm water for 1 minute.

SCORING SYSTEM:The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

Score Assessment
0 : Non irritant
0 - 10: Minimally irritant
11 - 25: Slightly irritant
26 - 56: Moderately irritant
57 - 84: Markedly irritant
>84: Extremely irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6 animals

Time point:

24 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6 animals

Time point:

48 h

Score:

0.83

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6 animals

Time point:

72 h

Score:

0.16

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

A slight to moderate conjunctival reaction was seen in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours and thereafter continued to do so until all eyes were normal by 48 hours (1/3 washed) 72 hours (2/3 unwashed 2/3 washed) and 6 days (1/3 unwashed). Staining of the conjunctivae and cornea by the compound was seen in the unwashed eyes for up to 40 hours.

Other effects:

None

Any other information on results incl. tables

Rabbit eye irritation scores-reference procedure:

		1 hour							6 hours							1 Day							2 Days							3 Days							6 Days
	Rabbit No	11	13	15	12	14	16		11	13	15	12	14	16		11	13	15	12	14	16		11	13	15	12	14	16		11	13	15	12	14	16		11	13	15	12	14	16
	Conjuctivae
A	Redness	2	2	2	2	1	1		-	-	-	-	-	-		1	2	1	2	1	1		1	1	-	1	1	1		-	1	-	-	-	-		-	-	-	-	-	-
B	Chemosis	2	2	1	2	1	2		-	-	-	-	-	-		1	1	-	1	-	-		1	1	-	1	-	-		-	-	-	-	-	-		-	-	-	-	-	-
C	Discharge	2	1	-	3	-	-		-	-	-	-	-	-		-	-	-	-	-	-		-	-	-	-	-	-		-	-	-	-	-	-		-	-	-	-	-	-
c=(A+B+C) X2	(max. 20)	12	10	6	14	4	6		-	-	-	-	-	-		4	6	2	6	2	2		4	4	-	4	2	2		-	2	-	-	-	-		-	-	-	-	-	-
Total	(Max.110)	12	10	6	14	4	6		-	-	-	-	-	-		4	6	2	6	2	2		4	4	-	4	2	2		-	2	-	-	-	-		-	-	-	-	-	-

Eyes washed in Nos. 14, 15 & 16 hours

No effects were observed for cornea and iris.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20043/B is a minimal eye irritant in the albino rabbit.

Executive summary:

A study was performed to determine the eye irriattion potential of FAT 20043/B in rabbits according to with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification. 100 mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes' of three of the rabbits with warm water for 1 minute. There was no effects observed for cornea and iris at 24 and 48 h observation period, however redness and discharge were seen but get reversed after 72 hrs. In conclusion, FAT 20043/B is a minimal eye irritant in the albino rabbit and based on the finding in the eye irritation studies, the test substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.