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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 281-420-3 | CAS number: 83949-60-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensitization to azo dyes: negative patch tests to yellow and red azo dyes in printed paper
- Author:
- Thierbach MA, Geursen-Reitsma AM, van Joost T
- Year:
- 1 992
- Bibliographic source:
- Contact Dermatitis, 1992, 27, 22-26
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Patch tests
- Principles of method if other than guideline:
- Patch tests were performed using C.I. Pigment Yellow 12 and other azo dyes to determine their sensitization potential on humans
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]
- EC Number:
- 228-787-8
- EC Name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]
- Cas Number:
- 6358-85-6
- Molecular formula:
- C32H26Cl2N6O4
- IUPAC Name:
- 2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(3-oxo-N-phenylbutanamide)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): 2-{2-[2-chloro-4-(3-chloro-4-{2-[2-oxo-1-(phenylcarbamoyl)propyl]diazen-1-yl}phenyl)phenyl]diazen-1-yl}-3-oxo-N-phenylbutanamide
- Common name: C. I. Pigment Yellow 12
- Molecular formula: C32H26Cl2N6O4
- Molecular weight: 629.5014 g/mol
- Substance type: organic
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- Name of the chemical: 2-{2-[2-chloro-4-(3-chloro-4-{2-[2-oxo-1-(phenylcarbamoyl)propyl]diazen-1-yl}phenyl)phenyl]diazen-1-yl}-3-oxo-N-phenylbutanamide
Common Name: C.I. Pigment Yellow 12
Molecular Formula: C32H26Cl2N6O4
Molecular Weight: 629.5014 g/mol
SMILES Notation: CC(=O)C(/N=N/c1c(cc(cc1)c2cc(c(cc2)/N=N/C(C(=O)Nc3ccccc3)C(=O)C)Cl)Cl)C(=O)Nc4ccccc4
InChI: 1S/C32H26Cl2N6O4/c1-19(41)29(31(43)35-23-9-5-3-6-10-23)39-37-27-15-13-21(17-25(27)33)22-14-16-28(26(34)18-22)38-40-30(20(2)42)32(44)36-24-11-7-4-8-12-24/h3-18,29-30H,1-2H3,(H,35,43)(H,36,44)/b39-37+,40-38+
Substance Type: Organic
Physical State: Solid
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Department of Dermatology and Venereology, Academic Hospital, The Netherlands
- Age at study initiation: women – mean age = 39.9 years
Men- mean age = 46.6 years
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white petrolatum
- Concentration / amount:
- 2% in white petrolatum
- Adequacy of induction:
- other: Patients with well established p-aminoazobenzene allergy were selected for the patch tests
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white petrolatum
- Concentration / amount:
- 2% in white petrolatum
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 32 patients (20 women and 12 men)
- Details on study design:
- A group of 32 patients with p-aminoazobenzene allergy were presumed that an increase in color printed newspapers might cause dermatitis. Patch tests were performed using the azo dyes in the printed papers along with specimens of the colored-printed newspaper. The test group consisted for 20 women and 12 men. 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.
The dyes were kindly provided by the firms Hoechst and Ciba-Geigy. To avoid false-negative reactions, a test concentration of 2% in white petrolatum was chosen. Patch tests were performed using uniform patches and following Standard procedures. - Challenge controls:
- 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD[para-phenylenediamine] were also tested with the same patch test series
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2% in white petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 32
- Clinical observations:
- C.I. Pigment Yellow 12 did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- C.I. Pigment Yellow 12 did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers
Hence, C.I Pigment Yellow 12 can be considered to be not sensitizing to skin. - Executive summary:
A group of 32 patients with p-aminoazobenzene allergy were presumed that an increase in color printed newspapers might cause dermatitis. Patch tests were performed using the azo dyes in the printed papers along with specimens of the colored-printed newspaper. The test group consisted for 20 women and 12 men. 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.
The dyes were kindly provided by the firms Hoechst and Ciba-Geigy. To avoid false-negative reactions, a test concentration of 2% in white petrolatum was chosen. Patch tests were performed using uniform patches and following Standard procedures.
C.I. Pigment Yellow 12 did not elicit a positive patch test reaction in any of the 32 patients positive to p-aminoazobenzene, nor in the 30 control volunteers
Hence, C.I Pigment Yellow 12 can be considered to be not sensitizing 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.
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.