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Diss Factsheets
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EC number: 947-340-4 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- theoretical assessment
- Type of information:
- other: theoretical assessment
- Adequacy of study:
- key study
- Study period:
- 2018-01-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
Data source
Reference
- Reference Type:
- other: theoretical assessment
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Theoretical assessment based on available information
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(2-hydroxyethyl) (6H-dibenz[c,e][1,2]oxaphosphorin-6-ylmethyl)succinate P-oxide
- EC Number:
- 264-313-6
- EC Name:
- Bis(2-hydroxyethyl) (6H-dibenz[c,e][1,2]oxaphosphorin-6-ylmethyl)succinate P-oxide
- Cas Number:
- 63562-34-5
- Molecular formula:
- C21H23O8P
- IUPAC Name:
- Butanedioic acid, 2-[(6-oxido-6H-dibenz[c,e][1,2]oxaphosphorin-6-yl)methyl]-, 1,4-bis(2-hydroxyethyl) ester
- Test material form:
- semi-solid (amorphous): gel
- Details on test material:
- Name: Ukanol FR 70
Batch no.: 4251318
Appearance: white solid
Composition: 9,10-Dihydro-9-oxa~10-[2,3-Di-(2-hydroxyethoxy) carbonylpropyl]-10-phosphaphenanthren-10-oxid; Bis(2-hydroxyethyl)-(6H-dibenz[c,e][1,2]oxaphos-phorin-6-yl-methyl)succinat-P-oxide
CAS No.: 63562-34-5
EINECS-No.: 264-313-6
Molecular formula: C21H23O8P
Molecular weight: 434 g/mo
Purity: app. 90% (HPLC)
Homogeneity: homogeneous
Constituent 1
- Radiolabelling:
- not specified
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Details on species / strain selection:
- not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not applicable
Administration / exposure
- Route of administration:
- other: not applicable
- Vehicle:
- other: not applicable
- Details on exposure:
- not applicable
- Duration and frequency of treatment / exposure:
- not applicable
Doses / concentrations
- Remarks:
- not applicable
- No. of animals per sex per dose / concentration:
- not applicable
- Positive control reference chemical:
- not applicable
- Details on study design:
- not applicable
- Details on dosing and sampling:
- not applicable
- Statistics:
- not applicable
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- yes
Applicant's summary and conclusion
- Executive summary:
1. Substance identity:
Name: Oligomeric Butanedioic acid, 2-[(6-oxido-6Hdibenz[c,e][1,2]oxaphosphorin-6-yl)methyl]-, 1,4-bis(2-hydroxyethyl) ester (DOP-ITS-Glycolic ester)
Structure: not applicable for UVCB; The substance is an oligomeric reaction product of Butanedioic acid, 2-[(6-oxido-6Hdibenz[c,e][1,2]oxaphosphorin-6-yl)methyl]-, 1,4-bis(2-hydroxyethyl) ester
Molecular formula: not applicable for UVCB
Molecular weight (MW): not applicable for UVCB
EC-Number: 264-313-6
Description: white solid
Molecular weight: The molecular weights of the components of the UVCB substance range from 434 (monomeric) to 2268 (heptameric).
2. Physico-chemical data:
Melting point: 38.7 to 82.9 °C
Boiling point: 224 °C - 246 °C (decomposition)
Relative density: 1.28 g/cm3(20°C)
Particle size distribution: not applicable, highly viscous
Vapour pressure: 6.26 * 10-6Pa at 20°C,
8.95 * 10-6Pa at 25°C
Surface tension: 62.26 mN/m
Water solubility: slightly soluble (0.1-100 mg/L)
Partition coefficient: log Pow: < 0.3 to 3.324
Hydrolysis: pH 7: DT-50 3.627 years
pH 8: DT-50 132.459 days
3. Toxikological data:
Acute oral toxicity: LD50> 2,000 mg/kg body weight (bw)
Acute dermal toxicity: LD50> 2,000 mg/kg bw
Subacute oral toxicity: NOAEL 300 mg/kg bw
Skin irritation: not irritating
Eye irritation: not irritating
Skin sensitisation: not sensitizing
Ames test: negative
Chromosome aberration negative
assay(in vitro):
Mammalian cell gene negative
mutation assay (HPRT)
(in vitro):
4. Toxicokinetic behaviour:
Since no toxicokinetic studies are available for DOP-ITS the assessment of the toxicokinetic behavior is based on the physico-chemical properties of the substance.
a) Absorption
Oral absorption:
The slightly water soluble substance DOP-ITS will dissolve in the gastrointestinal fluids to a limited degree.
Its high molecular weight, the moderate water solubility and the moderate log Pow of < 0.3 to 3.324 do not favor its absorption in the gastrointestinal tract by passive diffusion.
Since the molecular weight is above 600 Dalton the substance may not be taken up by passing through aqueous pores of the epithelial barrier. Paracellular permeability is related to the pores in the epithelial barrier. The paracellular pathway accepts molecules with molecular mass <600 Da.
Therefore, for evaluation of DOP-ITS in the chemical safety assessment, the oral absorption is set at 10 %.
The results of the toxicity studies with DOP-ITS do not provide any reason to deviate from this proposed degree of oral absorption.
Dermal absorption:
According to the criteria given in the ECHA guidance document “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance”,November 2012 (version 1.1) 10 % dermal absorption will be considered in case MW > 500 g/Mol and log Pow <-1 and >4, otherwise 100 % dermal absorption is assumed.
In consequence, 10 % dermal absorption is proposed for DOP-ITS.
Respiratory absorption:
Deposition pattern for dusts depends on the particle sizes of the substance to be inhaled. In general, particles having an aerodynamic diameter of greater than 10 µm are deposited in the nasopharyngeal region. Particles smaller than 10 µm are capable for reaching the alveolar region of the respiratory tract.
Since DOP-ITS is a highly viscous semi-solid substance no exposure can be assumed.
b) Distribution
After absorption DOP-ITS is expected not to distribute easily throughout the body based on its high molecular weight, the log Pow > 0 (some lipophilicity) and the low water solubility.
Since the log Pow is < 0.3 to 3.324, DOP-ITS can also distribute into cells to a minor extent so that the intracellular concentration may be higher than the extracellular concentration, particularly in fatty tissues.
Since the log Pow of DOP-ITS is < 4 the substance is not expected to accumulate within the body.
c) Metabolism
Once absorbed, the mammalian organism may metabolize the substance DOP-ITS by hydroxylation of appropriate carbon and nitrogen atoms which may be followed by conjugation.
Potential metabolites of the monomeric UVCB component were simulated with the QSAR-toolbox of the OECD (Organization for Economic Co-operation and Development) available at:http://www.qsartoolbox.org/) (see above)
No further assessment of the biological relevance of the theoretically derived metabolites is possible due to lack of 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.
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