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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)
Endpoint summary
Administrative data
Description of key information
Skin Sensitization:
The skin sensitization potential of C.I Direct Blue 218[CAS: 28407 -37 -6] was estimated by SSS (2018) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor. C.I Direct Blue 218[CAS: 28407 -37 -6] was predicted to be not sensitizing to the skin of female Dunkin- Hartley guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- data is from OECD QSAR toolbox v3.3 and the QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: Estimated data
- Principles of method if other than guideline:
- Prediction was done using OECD QSAR toolbox v3.3
- GLP compliance:
- not specified
- Type of study:
- other: Estimated data
- 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 - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- no data available
- Route:
- intradermal and epicutaneous
- Vehicle:
- not specified
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20
- Details on study design:
- no data available
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- Clinical observations:
- no signs of sensitization observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Negative
- Conclusions:
- C.I Direct Blue 218[CAS: 28407 -37 -6] was predicted to be not sensitizing to the skin of female Dunkin- Hartley guinea pigs.
- Executive summary:
The skin sensitization potential of C.I Direct Blue 218 [CAS: 28407 -37 -6] was estimated by SSS (2018) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor. C.I Direct Blue 218[CAS: 28407 -37 -6] was predicted to be not sensitizing to the skin of female Dunkin- Hartley guinea pigs.
Reference
The
prediction was based on dataset comprised from the following
descriptors: "Skin Sensitisation"
Estimation method: Takes highest mode value from the 6 nearest neighbours
Domain logical expression:Result: In Domain
(((("a"
or "b" )
and ("c"
and (
not "d")
)
)
and ("e"
and (
not "f")
)
)
and ("g"
and "h" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Non-covalent interaction AND
Non-covalent interaction >> DNA intercalation AND Non-covalent
interaction >> DNA intercalation >> Fused-Ring Primary Aromatic Amines
AND Radical AND Radical >> Radical mechanism via ROS formation
(indirect) AND Radical >> Radical mechanism via ROS formation (indirect)
>> Fused-Ring Primary Aromatic Amines AND SN1 AND SN1 >> Nucleophilic
attack after metabolic nitrenium ion formation AND SN1 >> Nucleophilic
attack after metabolic nitrenium ion formation >> Fused-Ring Primary
Aromatic Amines by DNA binding by OASIS v.1.3
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion
formation AND SN1 >> Nitrenium Ion formation >> Primary aromatic amine
by DNA binding by OECD
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group All Lipid
Solubility < 0.01 g/kg AND Group All log Kow < -3.1 AND Group All
Melting Point > 200 C by Skin irritation/corrosion Exclusion rules by BfR
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group CN Lipid
Solubility < 0.4 g/kg OR (!Undefined)Group CNHal Lipid Solubility < 4
g/kg OR (!Undefined)Group CNHal Lipid Solubility < 400 g/kg OR
(!Undefined)Group CNS Surface Tension > 62 mN/m OR Exclusion rules not
met OR Group CN Aqueous Solubility < 0.0001 g/L OR Group CN Aqueous
Solubility < 0.1 g/L OR Group CN log Kow > 4.5 OR Group CN log Kow > 5.5
OR Group CN Melting Point > 180 C OR Group CN Molecular Weight > 290
g/mol OR Group CN Vapour Pressure < 0.001 Pa OR Group CNHal Aqueous
Solubility < 0.001 g/L OR Group CNHal Aqueous Solubility < 0.1 g/L OR
Group CNHal log Kow > 3.8 OR Group CNS log Kow < 0.5 OR Group CNS
Melting Point > 120 C OR Group CNS Melting Point > 50 C OR Group CNS
Molecular Weight > 620 g/mol by Skin irritation/corrosion Exclusion
rules by BfR
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Aniline AND Aryl AND Azo AND
Biphenyl AND Fused carbocyclic aromatic AND Naphtalene AND Phenol AND
Sulfonic acid by Organic Functional groups
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Unsaturated heterocyclic
fragment by Organic Functional groups
Domain
logical expression index: "g"
Parametric
boundary:The
target chemical should have a value of Water Solubility which is >=
-68.6 mg/L
Domain
logical expression index: "h"
Parametric
boundary:The
target chemical should have a value of Water Solubility which is <=
7.01E004 mg/L
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin Sensitization:
Various studies have been investigated for assessing the dermal sensitization potential of C.I Direct Blue 218 to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs along with predicted data for target chemical and its structurally similar read across substances,trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate(Chlorazol Black BH)[CAS: 2429-73-4] and Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate(ALLURA RED AC)[CAS: 25956-17-6]. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.
The skin sensitization potential of C.I Direct Blue 218[CAS: 28407 -37 -6] was estimated by SSS (2018) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor. C.I Direct Blue 218[CAS:28407 -37 -6] was predicted to be not sensitizing to the skin of female Dunkin- Hartley guinea pigs.
Modified Draize- Shelanski Repeat Insult Patch Test was performed (OTS0215154, NTRL report, last updated 1983) on human volunteers to ascertain the degree of sensitization caused bythe structurally similar read across substance, trisodium 5-amino-3-[(E)-2-(4-{4-[(E)-2-(7-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazen-1-yl]phenyl}phenyl)diazen-1 -yl]-4-hydroxynaphthalene-2,7-disulfonate(Chlorazol Black BH)[CAS: 2429-73-4].Undiluted Chlorazol Black BH [CAS:2429-73-4] was applied to the patch sites on the backs of 208 male volunteers for ten alternate-day 24-hour period under occlusion. Following a seven day rest period, challenge patches of Chlorazol Black BH [CAS:2429-73-4] were applied to the fresh sites on the backs of 208 male volunteers similar to the induction phase for 24 hours. The challenge sites were evaluated 24 hours after removal of the challenge patches.
No instances of contact sensitization were observed in any of the volunteers.
Hence, Chlorazol Black BH [CAS:2429-73-4] can be considered to be not sensitizing to skin.
Prophetic patch test was performed (487. Allura red AC (WHO Food Additives Series 15), 1981) on 200 human subjects for screening the skin sensitization potential caused bythe structurally similar read across substance, Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate(ALLURA RED AC)[CAS: 25956-17-6].Allura Red AC was applied either as a neat or as a 25% aqueous solution to the skin of 200 human subjects. The initial exposure to the compound was for 72 hours, and this was followed by a 24-hour application 10 to 14 days later. None of the subjects exhibited compound induced contact sensitization. Hence the chemical Allura Red AC (CAS No: 25956-17-6) was considered to be not sensitizing to the skin of 200 human subjects in a prophetic patch test.
Based on the available data for the target as well as its structurally similar read across substances and applying the weight of evidence approach,C.I Direct Blue 218[CAS: 28407 -37 -6] can be considered to be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,C.I Direct Blue 218[CAS: 28407 -37 -6] can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Available data for C.I Direct Blue 218[CAS:28407 -37 -6] indicates that it is not likely to cause dermal sensitization to skin.
C.I Direct Blue 218[CAS:28407 -37 -6] can be considered to be not sensitizer to skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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