Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 240-589-3 | CAS number: 16521-38-3 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 73015 aluminium salt.
- 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
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:
- other: Data is from QSAR Toolbox version 3.3
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: Prediction is done using QSAR Toolbox version 3.3
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 3.3
- GLP compliance:
- not specified
- Type of study:
- not specified
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
- Route:
- other: No details available
- Vehicle:
- no data
- Concentration / amount:
- No data available
- Route:
- other: No details available
- Vehicle:
- no data
- Concentration / amount:
- No data available
- No. of animals per dose:
- No data available
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
- Reading:
- other: Non-senstising
- Group:
- other: No data available
- Dose level:
- No data
- Clinical observations:
- No data
- Remarks on result:
- other: Reading: other: Non-senstising. Group: other: No data available. Dose level: No data. Clinical observations: No data.
- Interpretation of results:
- other: Negative
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The substance fd & c blue no. 2 is estimated to be not sensitising in an in guinea pig maximisation test.
- Executive summary:
Skin sensitisation property of fd & c blue no. 2 is predicted using QSAR toolbox version 3.3.
The substance fd & c blue no. 2 is estimated to be not sensitising in an in guuinea pig maximisation test.
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" or "e" or "f" ) and ("g" and ( not "h") ) ) and "i" ) and ("j" and "k" ) )
Domain logical expression index: "a"
Referential boundary: The target chemical should be classified as (!Undefined)Aluminum Compounds AND Neutral Organics by US-EPA New Chemical Categories
Domain logical expression index: "b"
Referential boundary: The target chemical should be classified as (!Undefined)Aluminum Compounds OR Neutral Organics by US-EPA New Chemical Categories
Domain logical expression index: "c"
Referential boundary: The target chemical should be classified as Aryl AND Cycloketone AND Diketone AND Fused carbocyclic aromatic AND Fused saturated heterocycles AND Indoline AND No functional group found AND Sulfonic acid by Organic Functional groups
Domain logical expression index: "d"
Referential boundary: The target chemical should be classified as Diketone AND Fused carbocyclic aromatic AND Fused saturated heterocycles AND Indoline AND No functional group found AND Overlapping groups AND Sulfonic acid by Organic Functional groups (nested)
Domain logical expression index: "e"
Referential boundary: The target chemical should be classified as Aliphatic Nitrogen, one aromatic attach [-N] AND Alpha,beta-unsaturated carbonyl compound [C=C(N)C(=O)] AND Aluminium [Al] AND Aromatic Carbon [C] AND Carbonyl, olefinic attach [-C(=O)-] AND Carbonyl, one aromatic attach [-C(=O)-] AND Hydroxy, sulfur attach [-OH] AND Ketone in a ring, olefinic aromatic attach AND Miscellaneous sulfide (=S) or oxide (=O) AND Nitrogen, two or tree olefinic attach [>N-] AND Olefinic carbon [=CH- or =C<] AND Suflur {v+4} or {v+6} AND Sulfinic acid [-S(=O)OH] AND Sulfonate, aromatic attach [-SO2-O] by Organic functional groups (US EPA)
Domain logical expression index: "f"
Referential boundary: The target chemical should be classified as Aromatic compound AND Cation AND Heterocyclic compound AND Sulfonic acid AND Sulfonic acid derivative by Organic functional groups, Norbert Haider (checkmol)
Domain logical expression index: "g"
Referential boundary: The target chemical should be classified as No alert found by Protein binding by OASIS v1.3
Domain logical expression index: "h"
Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Acyl transfer via nucleophilic addition reaction OR Acylation >> Acyl transfer via nucleophilic addition reaction >> Isocyanates, Isothiocyanates OR Acylation >> Direct acylation involving a leaving group OR Acylation >> Direct acylation involving a leaving group >> Azlactones and unsaturated lactone derivatives OR Acylation >> Direct acylation involving a leaving group >> Carbamates OR Acylation >> Ester aminolysis OR Acylation >> Ester aminolysis >> Amides OR Ionic interaction OR Ionic interaction >> Substituted guanidines OR Ionic interaction >> Substituted guanidines >> Guanidines OR Michael Addition OR Michael Addition >> alpha,beta-Unsaturated carbonyl compounds OR Michael Addition >> alpha,beta-Unsaturated carbonyl compounds >> Lactones OR Michael Addition >> Michael addition on conjugated systems with electron withdrawing group OR Michael Addition >> Michael addition on conjugated systems with electron withdrawing group >> alpha,beta-Carbonyl compounds with polarized double bonds OR Michael Addition >> Quinoide type compounds OR Michael Addition >> Quinoide type compounds >> Quinone methide(s)/imines; Quinoide oxime structure; Nitroquinones, Naphthoquinone(s)/imines OR Nucleophilic addition OR Nucleophilic addition >> Addition to carbon-hetero double bonds OR Nucleophilic addition >> Addition to carbon-hetero double bonds >> Ketones OR Schiff base formation OR Schiff base formation >> Direct acting Schiff base formers OR Schiff base formation >> Direct acting Schiff base formers >> 1,2-Dicarbonyls and 1,3-Dicarbonyls OR SN2 OR SN2 >> Nucleophilic substitution at sp3 carbon atom OR SN2 >> Nucleophilic substitution at sp3 carbon atom >> (Thio)Phosphates OR SN2 >> Nucleophilic substitution at sp3 carbon atom >> Alkyl halides OR SN2 >> Nucleophilic substitution at sp3 carbon atom >> alpha-Activated haloalkanes OR SN2 >> Nucleophilic substitution on benzilyc carbon atom OR SN2 >> Nucleophilic substitution on benzilyc carbon atom >> alpha-Activated benzyls OR SNAr OR SNAr >> Nucleophilic aromatic substitution on activated aryl and heteroaryl compounds OR SNAr >> Nucleophilic aromatic substitution on activated aryl and heteroaryl compounds >> Activated aryl and heteroaryl compounds by Protein binding by OASIS v1.3
Domain logical expression index: "i"
Referential boundary: The target chemical should be classified as Does NOT Biodegrade Fast by Biodeg probability (Biowin 7) ONLY
Domain logical expression index: "j"
Parametric boundary:The target chemical should have a value of log Kow which is >= -1.25
Domain logical expression index: "k"
Parametric boundary:The target chemical should have a value of log Kow which is <= -0.81
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitisation:
The study results for read-across substance (CAS: 483-20-5) are used for toxicity to skin sensitization. Since the read-across is a major component of the target Aluminium lake substance, the inference can be drawn using the information for the major component.
On the basis of prediction using QSAR Toolbox by SSS (2016), Skin sensitisation property of fd & c blue no. 2 was estimated to benot sensitising in guuinea pig maximisation test.
Peer reviewed articles were reviewed to determine the Skin sensitisation of the similar substance, C.I. Acid blue 74 (CAS no 860-22-0). The studies are summarized as below:
The indigo carmine compound (G. Mancuso et al 1990) was patch tested for the allergy in the 204 (191 male and 13 female) worker from 15 Italian feed mills. 1% test substance in petrolatum was applied on back of workers using Scanpor tape (Norgesplaster,Norway) for 48 hr. Reactions were read at 48 and 96 h according to the ICDRG scale. Indigo carmine shows positive reaction in two cases. 3 workers (workers with cutaneous complaints (contact dermatitis or pruritus sine materia)) shows positive reaction and 2 workers (workers without cutaneous complaints) shows positive reaction. Hence, the substance indigo carmine is reported to be skin sensitizing to human.
From Patch testing to FD&C and D&C dyes 2003; Patch test of substance FD&C Blue 2 was done with 21 patients. 2% of test substance in petrolatum was applied. No positive reaction was observed.
From review article (Richard J. Lewis, Sr., 2012)The indigo carmine compound was patch tested for the allergy in the 204 worker from 15 Italian feed mills. The prevalence of occupational contact dermatitis was 13.7%, 16.7% with contact dermatitis and 6.8% of asymptomatic subjects patch tested with indigo carmine. It shows that indigo carmine is skin sensitizing compound.
From review article (EFSA Journal., 2015) acute oral toxicity test was conducted on rat administered indigo carmine by oral route. LD50 value was found to be 2000 mg/kg. In acute oral toxicity test of chemical indigo carmine administered orally to rat.
Based on the key study used and its relative supporting data, the test material classify as Skin sensitisation.
Migrated from Short description of key information:
FD & C blue no. 2 was estimated to benot sensitising in guuinea pig maximisation test.
Justification for selection of skin sensitisation endpoint:
Data is from QSAR tool box nd of Klimish 2
Justification for classification or non-classification
Skin sensitisation:
Based on the key study used and its relative supporting data, the test material classify as Skin sensitisation
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.