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EC number: 249-008-8 | CAS number: 28407-37-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from authoritative databases and NTRL reports
Data source
Referenceopen allclose all
- Reference Type:
- other: Authoritative database
- Title:
- HSDB for the CAS: 28407-37-6
- Author:
- U.S National Library of Medicine
- Year:
- 2 003
- Bibliographic source:
- Hazardous Substances Databank [HSDB], U.S National Library of Medicine, last updated 2003
- Reference Type:
- secondary source
- Title:
- Report on Rabbit Eye Irritation for CAS- 28407-37-6
- Author:
- NTRL
- Year:
- 1 982
- Bibliographic source:
- OTS0206237, NTRL report, last updated 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- To determine the primary irritation index of C.I. Direct Blue 218 when instilled to the eyes of rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)
- EC Number:
- 249-008-8
- EC Name:
- Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)
- Cas Number:
- 28407-37-6
- Molecular formula:
- C32H16Cu2N6O16S4.4Na
- IUPAC Name:
- Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)
- Test material form:
- other: amorphous powder
- Details on test material:
- Name of the test chemical: Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)
Common Name: C.I Direct Blue 218
IUPAC name: tetrasodium (3E)-5-amino-3-{2-[4-(4-{2-[(2E)-8-amino-1-oxo-3,6-disulfonato-1,2-dihydronaphthalen-2-ylidene]hydrazin-1-yl}-3- hydroxyphenyl)-2-hydroxyphenyl]hydrazin-1-ylidene}-4-oxo-3,4-dihydronaphthalene-2,7-disulfonate dicopper
Molecular Formula: C32H20Cu2N6Na4O16S4
Molecular Weight: 1087.84 g/mol
SMILES Notation: c12c3c(c(S(=O)(=O)[O-])cc1cc(S(=O)(=O)[O])cc2N)N=Nc1ccc(cc1O[Cu]O3)c1cc2c(N=Nc3c(cc4c(c3O[Cu]O2)c(cc(c4)S(=O) (=O)[O-])N)S(=O)(=O)[O-])cc1.[Na+].[Na+].[Na+].[Na+]
InChI: 1S/C32H24N6O16S4.2Cu.4Na/c33-19-11-17(55(43,44)45)5-15-9-25(57(49,50)51)29(31(41)27(15)19)37-35-21-3-1-13(7-23(21)39) 14-2-4-22(24(40)8-14)36-38-30-26(58(52,53)54)10-16-6-18(56(46,47)48)12-20(34)28(16)32(30)42;;;;;;/h1-12,39-42H,33-34H2,(H,43,44,45)(H,46,47,48)(H,49,50,51)(H,52,53,54);;;;;;/q;2*+2;4*+1/p-8/b37-35-,38-36-;;;;;;
Substance Type: Organic
Physical State: Solid Deep purple to dark blue amorphous powder
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI)
Common Name: C.I Direct Blue 218
Molecular Formula: C32H20Cu2N6Na4O16S4
Molecular Weight: 1087.84 g/mol
SMILES Notation: c12c3c(c(S(=O)(=O)[O-])cc1cc(S(=O)(=O)[O])cc2N)N=Nc1ccc(cc1O[Cu]O3)c1cc2c(N=Nc3c(cc4c(c3O[Cu]O2)c(cc(c4)S(=O)(=O)[O-])N)S(=O)(=O)[O-])cc1.[Na+].[Na+].[Na+].[Na+]
InChI: 1S/C32H24N6O16S4.2Cu.4Na/c33-19-11-17(55(43,44)45)5-15-9-25(57(49,50)51)29(31(41)27(15)19)37-35-21-3-1-13(7-23(21)39)14-2-4-22(24(40)8-14)36-38-30-26(58(52,53)54)10-16-6-18(56(46,47)48)12-20(34)28(16)32(30)42;;;;;;/h1-12,39-42H,33-34H2,(H,43,44,45)(H,46,47,48)(H,49,50,51)(H,52,53,54);;;;;;/q;2*+2;4*+1/p-8/b37-35-,38-36-;;;;;;
Substance Type: Organic
Physical State: Solid
Code Number - 2146-00
Product Name: Lumisol Blue VG
Concentration: 100%
Mix Number: 384
TR r-number: 78-638
Description: Dark Grey Powder
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approximately 2.5 kg
- Housing: housed individually in suspended wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: After at least seven days equilibration
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): light controlled rooms
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- The lids were held closed for 1-second for even distribution of the test substance
- Observation period (in vivo):
- The eyes were examined and graded for irritation and corneal damage at 1, 24, 48 and 72 hours after instillation
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: The ocular reactions were graded and interpreted as described in –Appraisal of the Safety of Food. Drugs, and Cosmetics", Association of Food and Drug Officials of the United States. 1959 with the assistance of the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances".
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 11
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 9.7
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 14
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Moderately irritating to rabbit eyes
Any other information on results incl. tables
Table: Individual scores for the acute eye irritation study
Animal number |
Tissue |
Item |
readings |
Duration |
|||||
1 hour |
1 day |
2 days |
3 days |
7 days |
14 days |
||||
1 |
Cornea |
A |
|
0 |
0 |
0 |
0 |
0 |
0 |
B |
|
0 |
0 |
0 |
0 |
0 |
0 |
||
Total |
A*B*5 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
C |
|
a |
0a |
1a |
0 |
0 |
0 |
|
Total |
C*5 |
|
0 |
5 |
0 |
0 |
0 |
||
Conjunctivae |
D |
Redness |
A |
3b |
3b |
3b |
1 |
0 |
|
E |
Chemosis |
3 |
2 |
2 |
2 |
0 |
0 |
||
F |
Discharge |
3 |
2 |
2 |
1 |
1 |
0 |
||
Total |
(D+E+F)*2 |
12 |
14 |
14 |
12 |
4 |
0 |
||
TOTALS ADDED |
|
1+2+3 |
12 |
14 |
19 |
12 |
4 |
0
|
|
U.V Fluorescein scan |
|
|
|
0 |
|
0 |
0 |
0 |
|
2 |
Cornea |
A |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Total |
A*B*5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
C |
|
A |
a |
1a |
0 |
0 |
0 |
|
|
Total |
C*5 |
|
|
5 |
0 |
0 |
0 |
|
Conjunctivae |
D |
Redness |
a |
a |
a |
a |
1a |
a |
|
|
E |
Chemosis |
3 |
3 |
3 |
2 |
2 |
2 |
|
|
F |
Discharge |
2 |
2 |
2 |
1 |
1 |
1 |
|
|
Total |
(D+E+F)*2 |
10 |
10 |
10 |
6 |
6 |
6 |
|
TOTALS ADDED |
|
1+2+3 |
10 |
10 |
15 |
6 |
8 |
6
|
|
|
U.V Fluorescein scan |
|
|
|
0 |
|
0 |
0 |
0 |
3 |
Cornea |
A |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Total |
A*B*5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
C |
|
A |
a |
1a |
0 |
0 |
0 |
|
|
Total |
C*5 |
|
|
5 |
0 |
0 |
0 |
|
Conjunctivae |
D |
Redness |
A |
a |
a |
a |
a |
0 |
|
|
E |
Chemosis |
3 |
3 |
3 |
2 |
0 |
0 |
|
|
F |
Discharge |
3 |
2 |
2 |
1 |
0 |
0 |
|
|
Total |
(D+E+F)*2 |
12 |
10 |
10 |
6 |
0 |
0 |
|
TOTALS ADDED |
|
1+2+3 |
12 |
10 |
15 |
6 |
0 |
0
|
|
U.V Fluorescein scan |
|
|
|
1 |
|
0 |
0 |
0 |
|
4 |
Cornea |
A |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Total |
A*B*5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
C |
|
a |
a |
0a |
0 |
0 |
0 |
|
|
Total |
C*5 |
|
|
0 |
0 |
0 |
0 |
|
Conjunctivae |
D |
Redness |
a |
a |
1a |
a |
a |
a |
|
|
E |
Chemosis |
3 |
2 |
2 |
1 |
0 |
0 |
|
|
F |
Discharge |
2 |
2 |
1 |
1 |
0 |
0 |
|
|
Total |
(D+E+F)*2 |
10 |
8 |
8 |
4 |
0 |
0 |
|
TOTALS ADDED |
|
1+2+3 |
10 |
8 |
8 |
4 |
0 |
0
|
|
|
U.V Fluorescein scan |
|
|
|
0 |
|
0 |
0 |
0 |
5 |
Cornea |
A |
|
A |
0 |
0 |
0 |
0 |
0 |
|
|
B |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Total |
A*B*5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
C |
|
a |
a |
1a |
0a |
0 |
0 |
|
|
Total |
C*5 |
|
|
5 |
0 |
0 |
0 |
|
Conjunctivae |
D |
Redness |
a |
a |
a |
a |
a |
a |
|
|
E |
Chemosis |
3 |
2 |
2 |
2 |
1 |
0 |
|
|
F |
Discharge |
2 |
2 |
1 |
1 |
0 |
0 |
|
|
Total |
(D+E+F)*2 |
10 |
8 |
6 |
6 |
6 |
2 |
|
TOTALS ADDED |
|
1+2+3 |
10 |
8 |
11 |
6 |
2 |
0
|
|
U.V Fluorescein scan |
|
|
|
0 |
|
0 |
0 |
0 |
|
6
|
Cornea |
A |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Total |
A*B*5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
C |
|
a |
a |
0a |
0a |
0 |
0 |
|
|
Total |
C*5 |
|
|
0 |
0 |
0 |
0 |
|
Conjunctivae |
D |
Redness |
a |
a |
2a |
3ab |
a |
0 |
|
|
E |
Chemosis |
3 |
2 |
3 |
2 |
1 |
0 |
|
|
F |
Discharge |
3 |
2 |
3 |
2 |
1 |
0 |
|
|
Total |
(D+E+F)*2 |
12 |
8 |
16 |
14 |
4 |
0 |
|
TOTALS ADDED |
|
1+2+3 |
12 |
14 |
16 |
14 |
4 |
0
|
|
U.V Fluorescein scan |
|
|
|
0 |
|
0 |
0 |
0 |
|
A = stained by material –unable
to determine opacity
a- stained by material, b-brown spots
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The Primary Irritation Index calculated at 1, 24, 48, 72 hours, 7 and 14 days were 11, 9.7, 14, 8, 3 and 1 respectively.
Based on the scores, C.I. Direct Blue 218 can be considered to be moderately irritating to rabbit eyes. - Executive summary:
A study was performed in rabbits to determine the ocular irritation potential of C.I. Direct Blue 218.
6 New Zealand white rabbits were used for the study. The rabbits were equilibrated in the laboratory for at least seven days. Rabbits with irritated or damaged eyes were not used in this test. 0.1g test was instilled in the lower conjunctival sac of one eye of each rabbit and the lids held closed for approximately one second to insure even distribution of the test material over all surfaces of the eye. The other eye served as an untreated control. The eyes were examined and graded for irritation and corneal damage at 1, 24, 48 and 72 hours after instillation. Eyes not returning to a score of zero by 72 hours were graded on the seventh day after instillation. Eyes still not returning to a score of zero were graded on the fourteenth day after instillation. All eyes were examined by applying 1 drop of 2% fluorescein sodium ophthalmic solution, U.S.P., to the cornea pre-test, 24, 72 hours and 7 and 14 days after instillation. The fluorescein was rinsed from the eye with physiological saline.
The ocular reactions were graded and interpreted as described in –Appraisal of the Safety of Food. Drugs, and Cosmetics", Association of Food and Drug Officials of the United States, 1959 with the assistance of the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances".
The Primary Irritation Index calculated at 1, 24, 48, 72 hours, 7 and 14 days were 11, 9.7, 14, 8, 3 and 1 respectively.
Based on the scores, C.I. Direct Blue 218 can be considered to be moderately irritating to rabbit eyes.
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