Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 222-852-4 | CAS number: 3634-83-1
- 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

PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
As the available data does not allow a definitive conclusion on the PBT or vPvB properties, the screening criteria as mentioned in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (Table R. 11-1) are used to decide whether the substance (XDI) and its hydrolysis product (XDA) potentially fulfill the PBT or vPvB criteria. Only for assessments for which relevant data is available the results are reported.
Persistence Assessment
For XDI this is not relevant due to its hydrolytical instability. As XDA has been shown to be not readily biodegradable, the P criterion is potentially fulfilled for XDA. No conclusion can therefore be drawn for XDA based on the available data.
Bioaccumulation Assessment
For XDI this is not relevant due to its hydrolytical instability. As XDA has a calculated log Kow of 0.15, the B criterion is not potentially fulfilled for XDA.
Toxicity Assessment
Based on the read-across of the 90 day study from NBDI to XDI, XDI fulfils the T criterion for human health as XDI needs to be classified for Specific target organ toxicity – repeated (STOT-RE), Category 1 (H372). As acute EC50 and LC50 values for XDA are above 1 mg/L, the T criterion for environment is not potentially fulfilled for XDA.
Overall conclusion:Based on the assessment described in the subsections above the submission substance (XDI) and its hydrolysis product (XDA) are not considered as PBT / vPvB;
P
B
T
Relevant available (screening) data (XDI)
Not relevant due to its hydrolytical instability
Not relevant due to its hydrolytical instability
Classified as: STOT RE Category 1; EC50 and LC50: >1 mg/L
Relevant available (screening) data (XDA)
Not readily biodegradable
Calculated log Kow: 0.15
EC50 and LC50:
>1 mg/L
(Screening) criterion fulfilled (XDI and XDA)
XDI: No
XDA: Yes (screening criterion only)
XDI: No
XDA: No
XDI:
Yes (for human health);
No (for environment)
XDA: No
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