Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate

EC Number:

274-499-0

EC Name:

Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate

Cas Number:

70247-70-0

Molecular formula:

C19H14BrCl2N5O8S2.2Na

IUPAC Name:

disodium 4-[4-({5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl)-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: separately in V2A wire cages and fed on NAFAG, Gossau SG.
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

One application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 rabbits (3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 30 seconds after treatment
- Time after start of exposure: after 24 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 males and 3 females

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

Remarks:

3 males and 3 females

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

Remarks:

3 males and 3 females

Time point:

24/48/72 h

Score:

0.17

Max. score:

3

Reversibility:

fully reversible within: 48h

Remarks on result:

other: Animal no. 4 and 5 whose eyes were not rinsed after exposure had slight irritation at 24h observsation.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 males and 3 females

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48h

Remarks on result:

other: Animal no. 4 and 5 whose eyes were not rinsed after exposure had slight irritation at 24h observsation.

Other effects:

No other effects reported.

Any other information on results incl. tables

The irritation index was found to be 0 for the cornea, 0 for the iris and 0.5 for the conjunctivae.

Evaluation of the Eye Reactions

Eyes rinsed:

Animal No	Observation time (Hr)	Cornea	Iris	Conjunctivae
Rabbit 1	24	0	0	0
	48	0	0	0
	72	0	0	0
Rabbit 2	24	0	0	0
	48	0	0	0
	72	0	0	0
Rabbit 3	24	0	0	0
	48	0	0	0
	72	0	0	0

 

Eyes not rinsed:

Animal No	Observation time (Hr)	Cornea	Iris	Conjunctivae
Rabbit 4	24	0	0	6
	48	0	0	0
	72	0	0	0
Rabbit 5	24	0	0	8
	48	0	0	0
	72	0	0	0
Rabbit 6	24	0	0	0
	48	0	0	0
	72	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

FAT 40061 is considered to be as a minimal irritant to the eye of rabbits.

Executive summary:

To assess the acute eye irritation potential of FAT 40061 when exposed to rabbit eye, a study was performed in accordance to the procedure mentioned in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (19 59) of the AFDO. The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, their eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. Animal no. 4 and 5 whose eyes were not rinsed after exposure had slight irritation with conjunctiva at 24h observsation, which got reversed by 48h. No other irritation reactions were seen. The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0.5 for the conjunctivae. Therefore FAT 40061/A is considered to be as a minimal irritant to the eye of rabbits.