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EC number: 219-746-5 | CAS number: 2519-30-4
- 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

Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Physical Factors Determining the Early Local Tissue Reactions Produced by Food Colourings and Other Compounds Injected Subcutaneously
- Author:
- S. D. GANGOLLI, P. GRASSO and L. GOLBERG *
- Year:
- 1 967
- Bibliographic source:
- Fd Cosmet. Toxicol. Vol. 5, pp. 601-621, 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Principles of method if other than guideline:
- Subcutaneous repeated dose toxicity study of Black PN in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
- EC Number:
- 219-746-5
- EC Name:
- Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
- Cas Number:
- 2519-30-4
- Molecular formula:
- C28H21N5O14S4.4Na
- IUPAC Name:
- tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate
- Reference substance name:
- Black PN
- IUPAC Name:
- Black PN
- Details on test material:
- - Name of test material (as cited in study report):Black PN - Molecular formula (if other than submission substance):C28-H21-N5-O14-S4.4Na- Molecular weight (if other than submission substance):867.6873 g/mole- Substance type:Organic- Physical state:- Impurities (identity and concentrations):10 % Pb and 3 % As
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Shell or Carworth Farm E SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: No data available - Age at study initiation: No data available - Weight at study initiation: 150- 300 g- Fasting period before study: No data available - Housing: No data available - Diet (e.g. ad libitum): Spillers Small Laboratory Animal diet, ad libitum- Water (e.g. ad libitum): Water, ad libitum- Acclimation period: No data available ENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: 1 ml of a 2 % aqueous solution of the test substance (pH 6.5-7.5) was injected subcutaneously. TEST SITE- Area of exposure: No data available- % coverage: No data available - Type of wrap if used: No data available - Time intervals for shavings or clipplings: No data available REMOVAL OF TEST SUBSTANCE- Washing (if done): No data available - Time after start of exposure: No data available TEST MATERIAL- Amount(s) applied (volume or weight with unit): No data available - Concentration (if solution): 1 ml - Constant volume or concentration used: yes- For solids, paste formed: noVEHICLE- Justification for use and choice of vehicle (if other than water): No data available - Amount(s) applied (volume or weight with unit): No data available- Concentration (if solution): 2000 mg/kg- Lot/batch no. (if required): No data available- Purity: No data availableUSE OF RESTRAINERS FOR PREVENTING INGESTION: No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 weeks
- Frequency of treatment:
- Twice-weekly
Doses / concentrations
- Remarks:
- Doses / Concentrations:2000 mg/kg Basis:nominal per unit area
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- No data available
- Sacrifice and pathology:
- GROSS PATHOLOGY: No data availableHISTOPATHOLOGY: Yes The skin and subcutaneous tissue were removed, fixed in buffered formol saline and prepared for histological examination. Rates of absorption, Relationship between surface activity and tissue reaction and Protein-binding ability and lipophilic properties of protein-colouring complexes were examined.
- Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Dermal irritation:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- Clinical signs and mortalityNo data availableDermal IrritationNo data availableBody weight and weight gainNo data availableFood consumption and compound intakeNo data availableFood efficiencyNo data availableWater consumption and compound intakeNo data availableOpthalmoscopic examinationNo data availableHaematologyNo data availableClinical chemistryNo data availableUrinanalysisNo data availableNeurobehaviourNo data availableOrgan weightsNo data availableGross pathologyNo data availableHistopathologyWhen treated with 2000 mg/kg, Type ll tissue reactions were observed i.e. insufficient progressive lesions in treated rats. Details on resultsType II are not associated with the reported development of sarcoma in long-term tests
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Surface activity, lipid solubility and protein binding ability of food colouring studies
| Lipophilic properties | |||||||
Injected material | type of reaction after 10-20 injections | Depression of surface tension of water (%) | Protein binding (g/100 g protine) | colouring combining with 100 mM cholesterol lecithin mixed miceller solution (mM) | Protein-colouring complex partition in tricaprylan (%) | |||
Colouring | Cation | Concen (%) | Vol. (ml) |
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| Azo | ||||
Black PN | Na | 3 | 1.0 | ll | 6.3 | 96 | 4.8 | 0.1 |
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Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 2000 mg/kg when Shell or Carworth Farm E SPF male and female rats were treated with Black PN
- Executive summary:
In a Subcutaneous repeated dose toxicity study, Shell or Carworth Farm E SPF male and female rats were treated with Black PN in the concentration of 2000 mg/kg Twice-weekly. Skin and subcutaneous tissue were examined histopathologically. Type ll tissue reactions were observed i.e. insufficient progressive lesions in treated rats. In addition, Black PN shows weak physicochemical properties which indicate a self-limiting reaction (type II). Therefore, NOAEL was considered to be 2000 mg/kg when Shell or Carworth Farm E SPF male and female rats were treated with Black PN Subcutaneous for 10 weeks.
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