4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxy-N-(3-nitrophenyl)naphthalene-2-carboxamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study report

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: 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).

Principles of method if other than guideline:

The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the test chemical into the eye of the rabbits.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide

EC Number:

229-313-2

EC Name:

3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide

Cas Number:

6471-49-4

Molecular formula:

C24H17N5O7

IUPAC Name:

3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide

Test material form:

solid: particulate/powder

Details on test material:

IUPAC Name: 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamid
Common Name: Pigment Red 23
InChI:1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
Smiles: c12c(c(c(cc1cccc2)C(=O)Nc1cc(ccc1) [N+](=O)[O-])O)/N=N/c1c(ccc(c1)[N+](=O)[O-])OC
Name of test material (as cited in study report):TK-11451
Molecular formula:C24H17N5O7
Molecular weight: 213.2349 g/mol
Substance type:Organic
Physical State: Solid

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or tissues and environmental conditions:

- Weight at study initiation: 1.5 to 2 kgs
- Housing: In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages
- Diet (e.g. ad libitum): (NAFAG, Gossau SG, rabbit food)
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100mg (0.1g)

Duration of treatment / exposure:

7 days

Observation period (in vivo):

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

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

6 (3/sex)

Details on study design:

TEST SITE
- Area of exposure: the conjunctival sac of the left eye
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: after 24 hours
SCORING SYSTEM: the reactions were scored on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

Results and discussion

In vivo

Results

Irritation parameter:

other: primary irritation index

Basis:

mean

Time point:

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

Score:

0

Max. score:

110

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

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

Any other information on results incl. tables

Table 1: RESULTS OF RABBITS WITH EYE RINSED

Days after application	Rabbit 1 (female)			Rabbit 2 (female)			Rabbit 3 (female)
	Cornea	Iris	conjunctivae	Cornea	Iris	conjunctivae	Cornea	Iris	conjunctivae
1	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	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: RESULTS OF RABBITS WITH EYE NOT RINSED

Days after application	Rabbit 4 (male)			Rabbit 5 (male)			Rabbit 6 (male)
	Cornea	Iris	conjunctivae	Cornea	Iris	conjunctivae	Cornea	Iris	conjunctivae
1	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	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

 

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

The primary irritation index of the test chemical was estimated to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Hence, the test chemical was considered to be not irritating to the rabbits’ eye.

Executive summary:

An ocular irritation study was conducted to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the test chemical on the eye of the rabbits. The study was performed according to 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).

About (0.1g) of the test chemical were introduced into the conjunctival sac of the left eye of six rabbits (3/sex) of Russian breed 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 of the test chemical was estimated to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Hence, the test chemical was considered to be not irritating to the rabbits’ eye.