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Diss Factsheets
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EC number: 228-788-3 | CAS number: 6358-87-8
- 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
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Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because the substance has a low potential for bioaccumulation based on log Kow <=3 and a low potential to cross biological membranes
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment; however most probably relevant results due to high standards for testing applied by MITI, Japan.
- Justification for type of information:
- see Rationale and Justification for the Analogue Read-Across Approach used for the Registration of Pigment Orange 13, 34 and Pigment Red 38 (Chapter 13)
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 305 C (Bioaccumulation: Test for the Degree of Bioconcentration in Fish)
- Version / remarks:
- 12 May 1981
- GLP compliance:
- no
- Radiolabelling:
- no
- Vehicle:
- yes
- Test organisms (species):
- Cyprinus carpio
- Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 6 wk
- Nominal and measured concentrations:
- 0.15 mg/L and 0.015 mg/L nominal concentration;
Concentrations were measured twice a week, however measured concentrations not reported. - Details on estimation of bioconcentration:
- Calculation of BCF was performed as outlined in the guidance:
BCFn = (Concentration in exposed fish body after n weeks of exposure minus arithmetic mean concentration in control fish body at the start and after n weeks of exposure) divided by the arithmetic mean concentration in water. - Type:
- BCF
- Value:
- > 0.75 - <= 5.6 dimensionless
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: steady state probably reached
- Remarks:
- Conc.in environment / dose:0.15 mg/L
- Type:
- BCF
- Value:
- < 2.8 dimensionless
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: steady state probably reached
- Remarks:
- Conc.in environment / dose:0.015
- Details on results:
- Applied experimental conditions are very well documented in the publication by MITI, Japan, and according to OECD 305C (1981), however apart from the final results for BCF no measured values for experimental parameters such as measured concentrations in water and fish are given (reliability category 4). According to the kinetic model developed by Arnot & Gobas (2006) together with the equation given by OECD 305 (1996, equation 5 of Annex 4) the time to reach 80 percent of steady-state (T80) can be approximated using input parameters log Kow (1.17, see section 4), test temperature (25 deg C), lipid concentration in test fish (6%) and weight of test organism (30 g). With an assumed metabolic transformation rate of zero (no transformation, worst case) T80 can be approximated to be below 1 hour. As such, 6 weeks duration for uptake phase as of the experiment is most probably sufficient to reach steady state, an important prerequisite for the method to yield reliable results.
Arnot, J.A.; Gobas, F.A.P.C. (2006) A review of bioconcentration factor (BCF) and bioaccumulation factor (BAF) assessments for organic chemicals in aquatic organisms Environmental Reviews, 14, 257-297 - Validity criteria fulfilled:
- not specified
- Conclusions:
- In a 6 weeks bioconcentration test in Carp (Cyprinus carpio) applying flow through conditions according to OECD 305C at the two exposure concentrations the following values for the bioconcentration factor were determined (steady state method):
Exposure concentration 0.15 mg/L: BCF 5.6 (w.w.)
Exposure concentration 0.015 mg/L: BCF <2.8 (w.w.) - Executive summary:
In a 6 weeks bioconcentration test in Carp (Cyprinus carpio) applying flow through conditions according to OECD 305C at the two exposure concentrations the following values for the bioconcentration factor were determined (steady state method):
Exposure concentration 0.15 mg/L: BCF 5.6 (w.w.)
Exposure concentration 0.015 mg/L: BCF <2.8 (w.w.)
Applied experimental conditions are very well documented in the publication by MITI, Japan, and according to OECD 305C (1981), however apart from the final results for BCF no measured values for experimental parameters such as measured concentrations in water and fish are given (reliability category 4). According to the kinetic model developed by Arnot & Gobas (2006) together with the equation given by OECD 305 (1996, equation 5 of Annex 4) the time to reach 80 percent of steady-state (T80) can be approximated using input parameters log Kow (1.17, see section 4), test temperature (25 deg C), lipid concentration in test fish (6%) and weight of test organism (30 g). With an assumed metabolic transformation rate of zero (no transformation, worst case) T80 can be approximated to be below 1 hour. As such, 6 weeks duration for uptake phase as of the experiment is most probably sufficient to reach steady state, an important prerequisite for the method to yield reliable results.
Arnot, J.A.; Gobas, F.A.P.C. (2006) A review of bioconcentration factor (BCF) and bioaccumulation factor (BAF) assessments for organic chemicals in aquatic organisms Environmental Reviews, 14, 257-297
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Description of key information
The registration substance is practically insoluble and has a negligible vapour pressure. Due to an n-octanol/water partitioning coefficient below the trigger value of 4.5, a low biodegradation potential can be expected. As an insoluble solid the potential to cross biological membranes is negligible.
This is supported by a 6 weeks bioconcentration test in Carp (Cyprinus carpio) performed with Pigment Orange 13 according to OECD 305C. At the two exposure concentrations the following values for the bioconcentration factor were determined (steady state method):
Exposure concentration 0.15 mg/L: BCF 5.6 (w.w.)
Exposure concentration 0.015 mg/L: BCF <2.8 (w.w.)
Key value for chemical safety assessment
Additional information
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.
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