hexasodium 4-[3-(2-bromoprop-2-enamido)benzamido]-6-[(E)-2-[5-(2,3-dibromopropanamido)-2-sulfophenyl]diazen-1-yl]-5-hydroxynaphthalene-1,7-disulfonate 6-[(E)-2-[5-(2-bromoprop-2-enamido)-2-sulfophenyl]diazen-1-yl]-4-[3-(2-bromoprop-2-enamido)benzamido]-5-hydroxynaphthalene-1,7-disulfonate

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

Justification for type of information:

None

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 Poods, Drugs and Cosmetic (1959) of the US Association of Food and Drug Officials (AFDO).

Principles of method if other than guideline:

Guideline followed

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,7-Naphthalenedisulfonic acid, 4-[[3-[(2-bromo-1-oxo-2-propen-1-yl)amino]benzoyl]amino]-6-[2-[5-[(2-bromo-1-oxo-2-propen-1-yl)amino]-2-sulfophenyl]diazenyl]-5-hydroxy-, sodium salt (1:3) and Trisodium 6-[{5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl]-4-({3-[(2,3-dibromopropanoyl)amino]benzoyl}amino)-5-hydroxynaphthalene-1,7-disulfonate

EC Number:

941-899-8

Cas Number:

1625603-53-3

Molecular formula:

C29H18Br2N5Na3O13S3 . C29H19Br3N5Na3O13S3

IUPAC Name:

Reaction mass of 1,7-Naphthalenedisulfonic acid, 4-[[3-[(2-bromo-1-oxo-2-propen-1-yl)amino]benzoyl]amino]-6-[2-[5-[(2-bromo-1-oxo-2-propen-1-yl)amino]-2-sulfophenyl]diazenyl]-5-hydroxy-, sodium salt (1:3) and Trisodium 6-[{5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl]-4-({3-[(2,3-dibromopropanoyl)amino]benzoyl}amino)-5-hydroxynaphthalene-1,7-disulfonate

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): FAT 40065/A

Specific details on test material used for the study:

None

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian breed,

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: kept separately in V2A wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye served as a control

Amount / concentration applied:

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

Duration of treatment / exposure:

The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.

Observation period (in vivo):

24 hours and after 2, 3, 4 and 7 days

Number of animals or in vitro replicates:

6 rabbits (3 males/3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
- Time after start of exposure: 24 hr, 2 day, 3 day, 4day and 7 day

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

irritation index for cornea

Basis:

mean

Time point:

7 d

Score:

0

Results 2

Irritation parameter:

iris score

Remarks:

irritation index for iris

Basis:

mean

Time point:

7 d

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

irritation index for conjunctivae

Basis:

mean

Time point:

7 d

Score:

2.5

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

The irritation index was found to be 0 for the cornea, 0 for the iris and 2.5 for the conjunctivae.

Other effects:

None

Any other information on results incl. tables

Table 1: Eye irritation – individual scores (eyes rinsed)

Days after appl.	Rabbit 1 (male)			Rabbit 2 (male)			Rabbit 3 (male)
	Cornea	Iris	Conjunctiva	Cornea	Iris	Conjunctiva	Cornea	Iris	Conjunctiva
1	0	0	0	0	0	8	0	0	0
2	0	0	0	0	0	6	0	0	0
3	0	0	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0	0	0
7	0	0	0	0	0	0	0	0	0

 

Table 2: Eye irritation – individual scores (eyes not rinsed)

Days after appl.	Rabbit 4 (female)			Rabbit 5 (female)			Rabbit 6 (female)
	Cornea	Iris	Conjunctiva	Cornea	Iris	Conjunctiva	Cornea	Iris	Conjunctiva
1	0	0	12	0	0	12	0	0	12
2	0	0	8	0	0	10	0	0	8
3	0	0	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0	0	0
7	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40065/A is considered to be not an eye irritant.

Executive summary:

FAT 40065/A was subjected to eye irritation test. The procedure adopted was the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed, which were kept separately in V2A wire mesh cages and fed on NAFAG, Gossau SG, rabbit food and water ad libitum. Only rabbits showing normal ophthalmic findings were included in the test.

Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the 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 on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

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 2.5 for the conjunctivae. Therefore FAT 40065/A is to be considered as a minimal irritant to the eye of rabbits. However the scoring does not meet the threshold scores for classification as proposed by Regulation EC No. 1272/2008. Hence, FAT 40065/A is considered to be not an eye irritant.