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EC number: 249-008-8 | CAS number: 28407-37-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- Acute Dermal Irritation in Rabbits 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: 16 CFR 1500.41 &16 CFR 1500.3 Guidelines
- Principles of method if other than guideline:
- To determine the primary irritation index of C.I. Direct Blue 218 when applied to the skin 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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: at least seven days equilibration
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- The test sites were observed at 24 and 72 hours after removal of patches
- Number of animals:
- 6
- Details on study design:
- Details on study design
TEST SITE
- Area of exposure: back of the rabbits
- % coverage: dry surgical gauze, one inch square. two layers thick.
- Type of wrap if used: adhesive tape; the trunk was wrapped wi th impervious ma terial
SCORING SYSTEM: The dermal reactions were scored by the Draize technique at 24, 72 hours and the Primary Irritation Index (PII) was calculated
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of erythema or edema were observed on the intact and abraded skin of the 6 rabbits after 24 and 72 hours of patch removal.
Any other information on results incl. tables
Table: Individual scores for the acute dermal irritation study
Observations |
Rabbit number |
Mean Score
|
|
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|
||
Erythema and eschar formation |
||||||||
Intact skin -24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Abraded skin – 24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Intact skin – 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Abraded skin – 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
||||||||
Intact skin – 24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Abraded skin – 24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Intact skin – 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Abraded skin - 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Sum of the mean scores |
0 |
|||||||
Primary Dermal Index = sum of the mean scores/4 = 0.0
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- No signs of erythema or edema were observed on the intact and abraded skin of the 6 rabbits after 24 and 72 hours of patch removal.
The Primary Irritation Index was calculated to be 0.0.
Based on the scores and observations, it was concluded that C.I. Direct Blue 218[CAS: 28407-37-6] was not irritating to skin. - Executive summary:
A study was performed in rabbits to determine the dermal irritation potential of C.I. Direct Blue 218. The study was conducted as per 16 CFR 1500.41 &16 CFR 1500.3 Guidelines.6 New Zealand white rabbits were used for the study. After at least seven days of equilibration, the back and sides of each rabbit were clipped free of fur with an electric clipper. Rabbits with dermal lesions or irritation were replaced. One day after clipping, the left side of the spinal column was abraded (minor incisions which did not disturb the derma or produce bleeding). 0.5 g of the test material was applied to the intact and abraded skin of the back of the rabbits. The material was covered with dry surgical gauze, one inch square, two layers thick. The patches were secured with adhesive tape; the trunk was wrapped with impervious material. After 24 hours, the patches were removed. The dermal reactions were scored by the Draize technique at 24 and 72 hours. The primary dermal index was calculated.
No signs of erythema or edema were observed on the intact and abraded skin of the 6 rabbits after 24 and 72 hours of patch removal.
The Primary Irritation Index was calculated to be 0.0.
Based on the scores and observations, it was concluded that C.I. Direct Blue 218 [CAS: 28407-37-6] was not irritating to skin.
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