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EC number: 229-313-2 | CAS number: 6471-49-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 1 974
- 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 compound Pigment Red 23 (CAS No: 6471-49-4) into the eye of the rabbits.
- GLP compliance:
- not specified
Test material
- 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-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Details on test material:
- 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 (if other than submission substance):C24H17N5O7
- Molecular weight (if other than submission substance):213.2349 g/mol
- Substance type:Organic
Constituent 1
- Specific details on test material used for the study:
- 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:TK-11451
- Molecular formula:C24H17N5O7
- Molecular weight:213.2349 g/mol
- Substance type: Organic
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
- 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
- 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 chemical TK 11451/ Pigment Red 23 (CAS No: 6471-49-4) was estimated to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Hence Pigment Red 23 (CAS No: 6471-49-4) was considered to be not irritating to the rabbits’ eye.
- Executive summary:
An ocular irritation study was conducted on six rabbits (3/sex) of Russian breed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound Pigment Red 23 (CAS No: 6471-49-4) on the eye of the rabbits.
In this test, about (0.1g) of the test substance Pigment Red 23 (CAS No: 6471-49-4) 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 of chemical TK 11451/ Pigment Red 23 (CAS No: 6471-49-4) was estimated to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Hence Pigment Red 23 (CAS No: 6471-49-4) was considered to be not irritating to the rabbits’ eye.
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