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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 217-699-5 | CAS number: 1934-21-0
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: information on Colipa reporr n. C29
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.45 (Skin Absorption: In Vitro Method)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- EC Number:
- 217-699-5
- EC Name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Cas Number:
- 1934-21-0
- Molecular formula:
- C16H12N4O9S2.3Na
- IUPAC Name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Test material form:
- solid: particulate/powder
- Details on test material:
- No data
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- pig
- Sex:
- not specified
Administration / exposure
- Vehicle:
- physiological saline
- Doses:
- 5 mg/ml in saline
- No. of animals per group:
- no data
- Details on study design:
- The skin absorption of Acid Yellow 23 was investigated on the outer skin of porcine ears (freshly obtained from the local slaughter-house, approx. 400 μm thick) with amountscorresponding to realistic use conditions. 5 mg of the pure dye (93% purity) dissolved in saline transferred to the donor chamber with 1 ml was applied to the skin.
Results and discussion
- Signs and symptoms of toxicity:
- no effects
- Dermal irritation:
- no effects
Percutaneous absorption
- Time point:
- 24 h
- Dose:
- 0.26 %
- Parameter:
- rate
- Remarks:
- penetration
- Absorption:
- ca. 13.2 other: µg/cm2
Any other information on results incl. tables
The conductivity over time ranged within the historical controls. No abrupt change in conductivity, indicating a loss of barrier properties of the skin, occurred in any chamber up to the maximal duration of the experiments. The mean recovery of the test item for experiment I and II were 94.5 ± 6.88 % and 97.5 ± 4.24 %. The majority of the test item (91 % in the first experiment, 78 % in the second experiment) was determined in the donor chamber solution. No measurable penetration through the skin was observed at any time point in the first and in the second study. Taking into account the detection limits a worst case of penetrated Acid Yellow 23 gives an upper limit of 5.0 μg of the test item (0.11 % of the applied total amount) in the first experiment and 5.9 μg of the test item (0.12 % of the applied total amount) in the second experiment. Together with the skin extracts (total skin) the worst case considerations of penetrated test item result in 5.4 μg/cm2 (0.11 % of the applied total amount) in the first and 13.2 μg/cm2 (0.26 % of the applied total amount) in the second study.
Applicant's summary and conclusion
- Conclusions:
- Low skin penetration
- Executive summary:
Under the described test conditions, skin penetration of Acid Yellow 23 is low. A skin penetration rate of 5.4 μg Acid Yellow 23/cm² (about 0.11 % of the applied amount) and 13.2 μg Acid Yellow 23/cm² (0.26 % of the applied dose) within 24 hours has been calculated for the pure substance and a commercial formulation, respectively, including the amounts present in the stratum corneum and thus assuming worst case conditions. A penetration rate of 13.2 μg/cm² (0.26 %) representing the highest value derived from the above described test will be used as a worst case scenario for the final risk assessment.
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.