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EC number: 204-934-1 | CAS number: 129-17-9
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from Scientific Opinion document on the re-evaluation of Patent Blue V as a food additive, published by the European Food Safety Authority
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Scientific Opinion on the re-evaluation of Patent Blue V (E 131) as a food additive, EFSA Panel on Food Additives and Nutrient Sources added to Food
- Author:
- European Food Safety Authority (EFSA), Parma, Italy
- Year:
- 2 015
- Bibliographic source:
- Scientific Opinion on the re-evaluation of Patent Blue V (E 131) as a food additive, EFSA Panel on Food Additives and Nutrient Sources added to Food, European Food Safety Authority (EFSA), Parma, Italy, EFSA Journal 2013;11(3):2818, April’ 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline details not available
- Principles of method if other than guideline:
- Absorption, distribution, metabolism and excretion of the chemical hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt (Synonym: Patent Blue V) as a food additive was investigated
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- EC Number:
- 204-934-1
- EC Name:
- Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- Cas Number:
- 129-17-9
- Molecular formula:
- C27H32N2O6S2.Na
- IUPAC Name:
- hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
- Reference substance name:
- hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt (Synonym: Patent Blue V)
- IUPAC Name:
- hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt (Synonym: Patent Blue V)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- CAS No: 129-17-9Name in test report: (14C) Patent Blue VType of chemical: Organic
Constituent 1
Constituent 2
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on exposure:
- Groups of male and female Sprague-Dawley rats were given oral doses between 1.6 and 3.2 mg (14C) Patent Blue V/kg bw, and then killed at intervals of up to 48 hours.
- Duration and frequency of treatment / exposure:
- Duration of study – 72 to 120 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:1.6 and 3.2 mg (14C) Patent Blue V/kg bw
- No. of animals per sex per dose / concentration:
- 6
- Control animals:
- not specified
- Positive control reference chemical:
- Details not available
- Details on study design:
- Details not available
- Details on dosing and sampling:
- Details not available
- Statistics:
- Details not available
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Low absorption observed after oral administration from the gastrointestinal (GI)tract of the rats
- Type:
- distribution
- Results:
- Wide tissue distribution was observed. Small amounts of the dose were present in the carcass at 72 hours and less than 0.1 % of the dose was present at 120 hours.
- Type:
- metabolism
- Results:
- 2 substances representing 30-32 % and 12-14 % of the urinary radioactivity and 3 minor components were detected but not identified.
- Type:
- excretion
- Results:
- In 6 male rats given oral doses of 1 to 1.5 mg (14C) Patent Blue V/kg bw, a total of 93 % of the dose appeared in the faeces within 24 hours. Radioactivity extracted from the faeces in these studies was in the form of unchanged colour.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- 2 substances representing 30-32 % and 12-14 % of the urinary radioactivity and 3 minor components were detected but not identified.
Any other information on results incl. tables
There was some evidence for preferential accumulation of radioactivity in the thyroid.
The early rapid elimination of the majority of the radioactivity was followed by a much slower excretion of the remainder (possibly as a result of coprophagy).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study resultsIn an in-vivo study carried out on Sprague-Dawley male rats, upon oral administration, a total of 93 % of the dose appeared in the faeces within 24 hours. Less than 0.5 % of the radioactivity was excreted in the urine (most within the first 4 hours). There was low absorption of the administered chemicals. There was some evidence for preferential accumulation of radioactivity in the thyroid. However, since the majority of the adminstered chemical was eliminated out of the body of the rats, the bio-accumulation potential of the chemical hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt Synonym: (14C) Patent Blue V appears to be low.
- Executive summary:
In an in-vivo study carried out onSprague-Dawley male rats, upon oral administration, a total of 93 % of the dose appeared in the faeces within 24 hours. Less than 0.5 % of the radioactivity was excreted in the urine (most within the first 4 hours). There was low absorption of the administered chemicals. There was some evidence for preferential accumulation of radioactivity in the thyroid. However, since the majority of the adminstered chemical was eliminated out of the body of the rats, the bio-accumulation potential of the chemicalhydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt Synonym: (14C) Patent Blue V appears to be low.
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