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EC number: 229-872-2 | CAS number: 6798-03-4
- 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
Endpoint summary
Administrative data
Description of key information
The skin sensitization potential of target chemical disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) was assessedin various experimental studies which were conducted on guinea pigs and humans for target chemicaldisodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) and its structurally similar read across substanceAcid Red 18 (CAS No: 2611-82-7) andfunctionally similar read across substancesD & C Red No. 6 (CAS no: 5858-81-1) and D & C Red no. 33 (CAS no: 3567-66-6). The predicted data usingQSAR toolboxhas also been compared with the experimental data.Based on the available data for the target and read across substances and applying the weight of evidence approach, it can be concluded that chemical disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
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 version 3.3 and QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: estimated data
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 3.3
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No data available
- Specific details on test material used for the study:
- - Name of the test material (IUPAC name): disodium [μ-[[7,7'-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-)
- Molecular formula: C32H19Cu2N7Na2O14S4
- Molecular weight: 1026.87 g/mol
- Smiles: c1(S(=O)(=O)[O-])c(\N=N\c2cc(ccc2[O-])S(=O)(=O)N)c([O-])c2ccc(Nc3cc4cc(c(\N=N\c5c(ccc(c5)S(=O)(=O)N)[O-])c(c4cc3)[O-])S(=O)(=O)[O-])cc2c1.[Na+].[Na+].[Cu+2].[Cu+2]
- Inchl: 1S/C32H25N7O14S4.2Cu.2Na/c33-54(44,45)19-3-7-25(40)23(13-19)36-38-29-27(56(48,49)50)11-15-9-17(1-5-21(15)31(29)42)35-18-2-6-22-16(10-18)12-28(57(51,52)53)30(32(22)43)39-37-24-14-20(55(34,46)47)4-8-26(24)41;;;;/h1-14,35,40-43H,(H2,33,44,45)(H2,34,46,47)(H,48,49,50)(H,51,52,53);;;;/q;2*+2;2*+1/p-6/b38-36+,39-37+;;;;
- Substance type: Organic - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- intradermal and epicutaneous
- Vehicle:
- not specified
- Concentration / amount:
- No data available
- Day(s)/duration:
- No data available
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- No data available
- Day(s)/duration:
- 72 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20
- Details on study design:
- No data available
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- No data available
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No skin sensitization was observed in treated group.
- Remarks on result:
- no indication of skin sensitisation
- Cellular proliferation data / Observations:
- No skin sensitization was observed in treated group.
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The chemical disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) was estimated to be not sensitizing to the skin of Dunkin-Hartley guinea pigs. Based on the estimated result disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) failed to induce skin sanitization effects and hence is considered to be not sensitizing to Dunkin-Hartley guinea pigs.
- Executive summary:
The skin sensitization potential of disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) was estimated using OECD QSAR toolbox version 3.3 with log Pow as the primary descriptor. The chemical disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) was estimated to be not sensitizing to the skin of Dunkin-Hartley guinea pigs. Based on the estimated result disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) failed to induce skin sanitization effects and hence is considered to be not sensitizing to Dunkin-Hartley guinea pigs and can be classified under the category ˋ Not Classified’ as per CLP regulation.
Reference
The
prediction was based on dataset comprised from the following
descriptors: "Skin Sensitisation"
Estimation method: Takes highest mode value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
((((((((((((("a"
or "b" or "c" or "d" )
and "e" )
and "f" )
and ("g"
and (
not "h")
)
)
and ("i"
and (
not "j")
)
)
and ("k"
and (
not "l")
)
)
and ("m"
and (
not "n")
)
)
and "o" )
and "p" )
and "q" )
and "r" )
and ("s"
and (
not "t")
)
)
and ("u"
and "v" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Amine OR Anion OR Aromatic
compound OR Azo compound OR Cation OR Secondary amine OR Secondary
aromatic amine OR Sulfonamide OR Sulfonic acid derivative by Organic
functional groups, Norbert Haider (checkmol) ONLY
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Aliphatic Nitrogen, one aromatic
attach [-N] OR Aliphatic Nitrogen, two aromatic attach [-N-] OR Aromatic
Carbon [C] OR Azo [-N=N-] OR Miscellaneous metal [Ni, Cu, Zr, Be] OR
Miscellaneous sulfide (=S) or oxide (=O) OR Nitrogen, two or tree
olefinic attach [>N-] OR Olefinic carbon [=CH- or =C<] OR Oxygen, one
aromatic attach [-O-] OR Suflur {v+4} or {v+6} OR Sulfamide, aromatic
attach [-SO2-N] OR Sulfonate, aromatic attach [-SO2-O] OR Sulfonyl
amide, aromatic attach [-S(=O)N-] OR Sulfur, nitrogen attach [-S-] by
Organic functional groups (US EPA) ONLY
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Aromatic amine OR Aryl OR Azo OR
Fused carbocyclic aromatic OR Overlapping groups OR Phenol OR
Sulfonamide OR Sulfonic acid by Organic Functional groups (nested) ONLY
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Aromatic amine OR Aryl OR Azo OR
Fused carbocyclic aromatic OR Naphtalene OR Phenol OR Sulfonamide OR
Sulfonic acid by Organic Functional groups ONLY
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OASIS v.1.3 ONLY
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OECD ONLY
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Non binder, MW>500 by Estrogen
Receptor Binding
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Non binder, without OH or NH2
group OR Very strong binder, OH group OR Weak binder, OH group by
Estrogen Receptor Binding
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Not possible to classify
according to these rules (GSH) by Protein binding potency
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as Highly reactive (GSH) OR Highly
reactive (GSH) >> 3-Alken-2-ones (MA) by Protein binding potency
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Inclusion rules not met by Eye
irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Organic sulphonic salts by Eye
irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as Group 1 - Alkali Earth
Li,Na,K,Rb,Cs,Fr AND Group 11 - Trans.Metals Cu,Ag,Au AND Group 14 -
Carbon C AND Group 15 - Nitrogen N AND Group 16 - Oxygen O AND Group 16
- Sulfur S by Chemical elements
Domain
logical expression index: "n"
Referential
boundary: The
target chemical should be classified as Group 3 - Lanthanoids OR Group
10 - Trans.Metals Ni,Pd,Pt OR Group 12 - Trans.Metals Zn,Cd,Hg OR Group
13 - Metalloids B OR Group 13 - Metals Al,Ga,In,Tl OR Group 14 -
Metalloids Si,Ge OR Group 14 - Metals Sn,Pb OR Group 15 - Metalloids
As,Sb OR Group 15 - Phosphorus P OR Group 16 - Selennm Se OR Group 17 -
Halogens Br OR Group 17 - Halogens Cl OR Group 17 - Halogens F OR Group
17 - Halogens F,Cl,Br,I,At OR Group 17 - Halogens I OR Group 2 -
Alkaline Earth Be,Mg,Ca,Sr,Ba,Ra OR Group 3 - Trans.Metals Sc,Y OR Group
4 - Trans.Metals Ti,Zr,Hf OR Group 5 - Trans.Metals V,Nb,Ta OR Group 6 -
Trans.Metals Cr,Mo,W OR Group 7 - Trans.Metals Mn,Tc,Re OR Group 8 -
Trans.Metals Fe,Ru,Os OR Group 9 - Trans.Metals Co,Rh,Ir by Chemical
elements
Domain
logical expression index: "o"
Referential
boundary: The
target chemical should be classified as Aromatic amine AND Aryl AND Azo
AND Fused carbocyclic aromatic AND Naphtalene AND Phenol AND Sulfonamide
AND Sulfonic acid by Organic Functional groups ONLY
Domain
logical expression index: "p"
Referential
boundary: The
target chemical should be classified as Aromatic amine AND Aryl AND Azo
AND Fused carbocyclic aromatic AND Naphtalene AND Phenol AND Sulfonamide
AND Sulfonic acid by Organic Functional groups ONLY
Domain
logical expression index: "q"
Referential
boundary: The
target chemical should be classified as Aliphatic Nitrogen, one aromatic
attach [-N] AND Aliphatic Nitrogen, two aromatic attach [-N-] AND
Aromatic Carbon [C] AND Azo [-N=N-] AND Miscellaneous metal [Ni, Cu, Zr,
Be] AND Miscellaneous sulfide (=S) or oxide (=O) AND Nitrogen, two or
tree olefinic attach [>N-] AND Olefinic carbon [=CH- or =C<] AND Oxygen,
one aromatic attach [-O-] AND Suflur {v+4} or {v+6} AND Sulfamide,
aromatic attach [-SO2-N] AND Sulfonate, aromatic attach [-SO2-O] AND
Sulfonyl amide, aromatic attach [-S(=O)N-] AND Sulfur, nitrogen attach
[-S-] by Organic functional groups (US EPA) ONLY
Domain
logical expression index: "r"
Referential
boundary: The
target chemical should be classified as Aliphatic Nitrogen, one aromatic
attach [-N] AND Aliphatic Nitrogen, two aromatic attach [-N-] AND
Aromatic Carbon [C] AND Azo [-N=N-] AND Miscellaneous metal [Ni, Cu, Zr,
Be] AND Miscellaneous sulfide (=S) or oxide (=O) AND Nitrogen, two or
tree olefinic attach [>N-] AND Olefinic carbon [=CH- or =C<] AND Oxygen,
one aromatic attach [-O-] AND Suflur {v+4} or {v+6} AND Sulfamide,
aromatic attach [-SO2-N] AND Sulfonate, aromatic attach [-SO2-O] AND
Sulfonyl amide, aromatic attach [-S(=O)N-] AND Sulfur, nitrogen attach
[-S-] by Organic functional groups (US EPA) ONLY
Domain
logical expression index: "s"
Referential
boundary: The
target chemical should be classified as Not categorized by Repeated dose
(HESS)
Domain
logical expression index: "t"
Referential
boundary: The
target chemical should be classified as Aliphatic nitriles
(Hepatotoxicity) Rank B by Repeated dose (HESS)
Domain
logical expression index: "u"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -4.53
Domain
logical expression index: "v"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= -0.566
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studieshas been investigated for the test chemicaldisodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs and humans for target chemicaldisodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) and its structurally similar read across substanceAcid Red 18 (CAS No: 2611-82-7) andfunctionally similar read across substancesD & C Red No. 6 (CAS no: 5858-81-1) and D & C Red no. 33 (CAS no: 3567-66-6). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data and summarized as below;
The skin sensitization potential of disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor. disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) was estimated to be not sensitizing to the skin of Dunkin-Hartley guinea pigs. Based on the estimated result disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) can be considered to be not sensitizing to Dunkin-Hartley guinea pigs.
The Guin JD. (Contact Dermatitis 2003: 49: 217–218) conducted skin sensitization study forread across substanceD & C Red No. 6 (CAS no: 5858-81-1) to determine the allergic contact dermatitis caused by the chemical via performing patch test on human patients. The dye was applied on15patients in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories. None of the treated patients showed any signs of allergic contact dermatitis. Hence the chemical D & C Red No. 6 (CAS no: 5858-81-1) can be considered as non-sensitizer to human skin.
The above results were supported by the Local Lymph Node Assay (LLNA) reported by the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) for read across chemical Acid Red 18 (CAS No: 2611-82-7) on 55 female (11 groups of 5 animals) mouse according to OECD Guideline 429.On days 0, 1 and 2 the animals received 25 μl of one of the test preparations or vehicle on the dorsal surface of each ear. On day 5 all mice received intravenous injection of tritium labelled thymidine in phosphate buffered saline, and 5 hours later they were killed humanely and the draining auricular lymph nodes were removed. Single cell suspensions were prepared for each animal, appropriately treated and measured by liquid scintillation counting. The stimulation indices were less than 3 at all tested concentrations, hence an EC3 value could not be calculated, and thus the test substanceAcid Red 18 (CAS No: 2611-82-7)was considered as non-sensitizing in the vehicles tested.
The above results were further supported by the Maximization test reported by Scientific Committee on Consumer Safety (SCCS){ Opinion on Acid Red 33 ,Scientific Committee on Consumer Safety (SCCS), SCCP/1102/07} in female 15 (10 test and 5 control)Guinea pig for read across chemical D & C Red no. 33 (CAS no: 3567-66-6). The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction. The test areas are pretreated with 10 sodium-laureth-sulfates (SLS) 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No known skin sensitization reactions were observed in treated as well as control group. Hence the chemical D& C Red no. 33 (CAS no: 3567-66-6) was considered to be not sensitizing.
Thus on the basis of available data for thetarget chemicaldisodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) and its structurally similar read across substanceAcid Red 18 (CAS No: 2611-82-7) andfunctionally similar read across substancesD & C Red No. 6 (CAS no: 5858-81-1) and D & C Red no. 33 (CAS no: 3567-66-6),it can be concluded thatchemical disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) and its structurally similar read across substance Acid Red 18 (CAS No: 2611 -82 -7) and functionally similar read across substances D & C Red No. 6 (CAS no: 5858 -81 -1) and D & C Red no. 33 (CAS no: 3567 -66 -6) were observed in various studies. From the results obtained from these studies it is concluded that the chemical disodium [μ-[[7,7’-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) ; Direct Violet 66 (CAS No: 6798-03-4) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
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