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Diss Factsheets
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EC number: - | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: theoretical approach
- Adequacy of study:
- key study
- Study period:
- 2009-03-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is based on expert judgment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
- Objective of study:
- other: toxicokinetic assessment
- GLP compliance:
- no
- Remarks:
- not applicable
Test material
- Details on test material:
- - Name of test material (as cited in study report): Y-513
- Purity test date: no data
- Lot/batch No.: F-1570
- Expiration date of the lot/batch: 19 February 2013
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Results and discussion
- Preliminary studies:
- See below
Any other information on results incl. tables
The water solubility of the powder Y-513 is very low (<0.36 mg/L). Since in general a substance needs to be dissolved before it can be taken up from the gastro-intestinal tract, it is unlikely that Y-513 will show a high systemic exposure after oral administration. The absorption will furthermore be lowered by the relatively large molecular weight (657.55g/mol, component A; 723.58 - 2194.71, component B) of this substance limiting the passage through biological membranes. The presence of a sulphonate group in component B will also impair absorption as ionised substances do not easily pass the GI wall. Although the particles of the powder are not fairly large (MMAD 30.615 µm), the number of particles in the nanometer size range is low and uptake by pinocytosis therefore low. Its highly lipophilic character (logPow > 6.5) indicates that uptake by micellular solubilisation may be of particular importance. For risk assessment purposes the oral absorption of Y-513 is set at 10%. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.
In the gastro-intestinal tract the amide-bond might be cleaved by amidases and reduction of the azo-bond to produce two primary amines may take place. Absorbed Y-513 might undergo aromatic hydroxylation and conjugation (1). Significant distribution of the substance throughout the body is not expected based on its relatively high molecular weight and low water solubility. Because of the reduced molecular weight after the potential cleaving of the amide-bond and azo-bond, the conjugates might either be excreted via the bile or the urine.
Based on the particle size of Y-513 particles < 100μm, which have a potential to be inhaled, are present. Particles will predominantly settle in the nasopharyngeal region (particles with aerodynamic diameter > 1 -5 μm), although those reaching the tracheobronchial or pulmonary region are also present (2% < 1 μm and 16% < 5 μm).The low water solubility of Y-513 indicates a potential for accumulation, while its lypophilic character (logPow > 6.5) indicates the potential for absorption directly across the respiratory tract epithelium. For risk assessment purposes the inhalation absorption of Y-513 is set at 100% as a worst case assumption.
Y-513 being a solid with a relatively high molecular weight has no real potential for dermal absorption. Furthermore, its low water solubility and highly lipophilic character do not facilitate dermal absorption. As the criteria for 10% dermal absorption as given in the TGD (2) (MW > 500 and logPow > 4) are met, 10% dermal absorption of Y-513 is proposed for risk assessment purposes. The results of the toxicity studies do not provide reasons to deviate from this proposed dermal absorption factor.
Based on the present available data, no additional conclusions can be drawn on the distribution, metabolism and excretion of Y-513 after dermal and inhalatory absorption.
REFERENCES
1. A. Parkinson. In: Casarett and Doull’s Toxicology, The basic science of poisons. Sixth edition. Ed. C.D. Klaassen. Chapter 6: Biotransformation of xenobiotics., McGraw-Hill,New York, 2001
2. ECB EU Technical Guidance Document on Risk Assessment, 2003
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
For risk assessment purposes the following absorption factors were derived:
oral absorption factor: 10%
dermal absorption factor: 10%
inhalation absorption factor: 100%
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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