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EC number: 249-008-8 | CAS number: 28407-37-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 secondary source
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database
- Title:
- Acute Dermal Toxicity in Rats
- Author:
- U.S. National Library of Medicine
- Year:
- 2 017
- Bibliographic source:
- HSDB (Hazardous Substances Data Bank); US national Library of Medicine,2017
- Reference Type:
- secondary source
- Title:
- Acute Dermal toxicity in rabbits
- Author:
- National Technical Reports Library
- Year:
- 1 982
- Bibliographic source:
- National Technical Reports Library, Fiche No. OTS 206237,1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute dermal toxicity test was carried out to study the effects of 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) (28407-37-6) on rabbits.
- GLP compliance:
- not specified
- Test type:
- other: no data
- Limit test:
- no
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-)
- Details on test material:
- - Name of test material (IUPAC name): 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: Direct Blue 218
- Molecular formula: C32H20Cu2N6Na4O16S4
- Molecular weight: 1087.82 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+]
- InChl: 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
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Lumisol blue VG
- Molecular formula :C32H20Cu2N6Na4O16S4
- Molecular weight :1087.82 g/mol
- Substance type:organic
- Physical state:Dark Grey Powder
- Purity :100%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Age at study initiation: approximately 8 to 11 weeks
- Housing: The rabbits were individually housed in elevated wire mesh cages in temperature controlled rooms reserved exclusively for rabbits on acute tests
- Diet (e.g. ad libitum): Purina Rabbit Chow was provided ad libitum
- Water (e.g. ad libitum): water was provided ad libitum
- Acclimation period:7 days
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The test substance was applied to the the intact and abraded skin.
-Type of wrap if used: The test site was covered with gauze and the trunk was wrapped with impervious material for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was washed with warm tap water
Details on exposure
VEHICLE
- Amount of vehicle (if gavage): 50% w/v
DOSAGE PREPARATION (if unusual):test substance was soluble in distilled water - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Total: 4 animals
2000 mg/kg bw:2 male and 2 female - Control animals:
- not specified
- Details on study design:
- Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations : Skin sites were read again at 7 and 14 days. The rabbits were observed daily for 14 days for signs of toxicity and mortality.
-frequency of weighing: Body weights were recorded pretest and at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights - Statistics:
- no data
Results and discussion
- Preliminary study:
- no data
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- No mortality was observed at dose 2000 mg/kg bw
- Clinical signs:
- other: Animal 1 - Diarrhea, days 10 and 11; bloated abdomen, day 11:Few feces in pan, days 11 and 12. Animal 2 - Lethargy, day 12.
- Gross pathology:
- Necropsy findings concluded that all animals appeared normal.
- Other findings:
- no data
Any other information on results incl. tables
TABLE 1:AcuteDermalToxicity in Rabbits
Individual Body Weights and Skin Grades
Rabbit Number |
Sex |
Weights - kg |
Redness |
Edema |
||||||
0 |
7 |
14 |
25H |
7 |
14 |
25H |
7 |
14 |
||
1 |
M |
2.8 |
2.8 |
2.8 |
0 |
0 |
0 |
0 |
0 |
0 |
2ab |
M |
2.5 |
2.7 |
2.7 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
F |
2.2 |
2.4 |
2.7 |
0 |
0 |
0 |
0 |
0 |
0 |
4ab |
F |
2.3 |
2.5 |
2.7 |
0 |
0 |
0 |
0 |
0 |
0 |
ab = abraded
Evaluation of Skin Reactions |
value |
Erythema & Eschar Formation: No erythema Very slight erythema (barely perceptible) Well defined erythema Moderate to severe erythema Severe erythema (beet redness) to slight eschar formation (injuries in depth) |
0 1 2 3 4 |
Ederra Formation: No edema Very slight edema (barely perceptible) Slight edema (edges of area well defined by definite raising) Moderate edema (raised approximately 1 millimeter) Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) |
0 1 2
3
4 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The LD50 value was considered to be >2000 mg/kg bw,when male and female New Zealand white rabbits were occlusively treated with 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) (28407-37-6) by dermal application following 14 days of observation period.
- Executive summary:
In acute dermal toxicity study, male and femaleNew Zealand white rabbitswere occlusively treated with 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) (28407-37-6) in the concentration of 2000 mg/kg bw by dermal application.Distilled water was used as vehicle.Twenty-four hours prior to dosing the backs of the rabbits were clipped free of fur with an Oster ANG-RA clipper head designed specifically for clipping rabbits. The rabbits were returned to their cages overnight. Just prior to dosing, the backs of even-numbered rabbits were abraded with a 21 gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum but did not disturb the derma or produce bleeding.The test site was covered with gauze and the trunk was wrapped with impervious material for 24 hours.Following removal of the binder at 24 hours. The test site was washed with warm tap water. One hour after washing, the test sites were graded for skin irritation according to the attached scale. Skin sites were read again at 7 and 14 day.No mortality was observed in treated rabbits at dose 2000 mg/kg bw.Clinical signs such asDiarrhea, bloated abdomen, Few feces in pan and Lethargy was observed in treated rabbits. Changes in body weight were observed. Necropsyfindings concluded that all animals appeared normal.Hence,The LD50 value was considered to be >2000 mg/kg bw,when 2male and 2 female New Zealand white rabbitswere occlusively treated with 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) (28407-37-6)by dermal application following 14 days of observation period.
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