Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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.