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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 224-909-9 | CAS number: 4548-53-2
- 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
Additional information
Appearance:
The test chemical disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxynaphthalene-1-sulphonate (Common Name: FD&C Red 4) was found to be a Red colored powder.
Melting Point:
The melting point determination of Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (CAS No. 4548-53-2) was done following OECD Guideline 102 and according to the metal block capillary method.The test item decomposes at 363.5 °C with colour change from red to black. The test was conducted in replicates and the mean decomposition point was found to be 363.5 °C at 966.5 hPa.
Boiling Point:
The melting point determination of Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (CAS No. 4548-53-2) was done following OECD Guideline 102 and according to the metal block capillary method. The test item decomposes at 363.5 °C with colour change from red to black. The test was conducted in replicates and the mean decomposition point was found to be 363.5 °C at 966.5 hPa. Thus, it was not possible to estimate the boiling point experimentally.
Density:
The mean density of test item was determined following OECD Guideline 109 and according to theOECD guideline 109 and according to themethod recommended in the International Pharmacopoeia, fourth Edition, 2014using bulk density apparatus.The mean pour density and tapped density of the test item Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate(CAS No. 4548-53-2) was found to be 0.2222 g/cm3 and 0.2720 g/cm3 at 20oC and 967.5 hPa. The relative density for the purpose of chemical safety assessment was considered to tbe the tapped density value of 0.2720 g/cm3.
Particle size distribution:
The particle size distribution of test item Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (CAS No. 4548-53-2) was determined by granulometric analysis with rotap sieve shaker. The particle size distribution was found to be in the range of 150 micron to 25 micron indicating that the particles are not of inhalable size
Vapour Pressure:
The vapour pressure of the test compound FD and C Red no 4 as predicted by EPI suite (Modified Grain method) is estimated to be 3.84E-021 Pa.
Partition coeffcient:
The partition coefficient (Log Kow/Pow) as predicted by EPI suite is estimated to be -0.0825.
Water Solubility:
The water solubility determination of test item Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (CAS No. 4548-53-2) was done gravimetrically as per the shake flask method using membrane filtration followed by air drying.The water solubility was found to be 130.40 g/Lat 30 °C indicating that the chemical is very water soluble.
Surface Tension:
In accordance with column 2 of Annex VII of the REACH regulation, this testing needs to be carried out only if surface activity is a desired property of the chemical. The chemical disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxynaphthalene-1-sulphonate (Common name: FD&C Red 4) is used as a personal care and home care color. For these uses, surface activity is not a desired property and hence this end point was considered for waiver.
Flash Point:
The flash point determination of Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (CAS No.4548-53-2) was done following closed cup method using Pensky-Martens flash point apparatus. The mean flash point was found to be greater than 250 °C at 966.9 hPa. For the purpose of chemical safety assessment, the flash point has been considered to be 251oC.
Auto Flammability:
The chemical disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxynaphthalene-1-sulphonate (Common Name: FD&C Red 4) does not catch fire spontaneously upon exposure to air under normal conditions of temperature and pressure. Thus, the chemical is unlikely to be "Auto Flammable". Thus, this end point was considered for waiver.
Flammability:
The NFPA rating for the chemical disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxynaphthalene-1-sulphonate (Common Name: FD&C Red 4) for flammability is 1, indicating that the chemical is not likely to be flammable under normal conditions of temperature and pressure. Thus, this end point was considered for waiver. The chemical is considered as "Non Flammable" for the purpose of chemical safety assessment.
Explosiveness:
In accordance with column 2 of Annex VII of the REACH regulation, the study is scientifically unjustified since there are no chemical groups associated with explosive properties present in the molecule of the chemical disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxynaphthalene-1-sulphonate (Common Name: FD&C Red 4), except the Azo group. Thus, the chemical is not likely to be explosive and has been considered as "Non-explosive" for the purpose of chemical safety assessment.
Oxidizing Properties:
In accordance with column 2 of Annex VII of the REACH regulation, the substance disodium 3-[(2,4-dimethyl-5-sulphonatophenyl) azo]-4-hydroxynaphthalene-1-sulphonate (Common Name: FD&C Red 4) is incapable of reacting exothermically with combustible materials,on the basis of the chemical structure. It is an organic substance containing oxygen atoms but no halogen and the oxygen atoms are not chemically bonded to nitrogen or oxygen. THus, the chemical is unlikely to exhibit oxidising properties and this study was therefore considered for waiver.
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.