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Diss Factsheets
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EC number: 203-813-0 | CAS number: 110-89-4
- 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
Toxicity to terrestrial plants
Administrative data
- Endpoint:
- toxicity to terrestrial plants: short-term
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
[Specific explanation in addition to field 'Justification for data waiving']
According to Regulation (EC) 1907/2006, Annex IX, Section 9.4.1 to 9.4.3, Column 2, studies on the toxicity to terrestrial organisms do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.
For the substance only industrial and professional uses with adequate risk mitigating measures are foreseen. Environmental exposure through widespread uses by consumers is excluded. Widespread uses by professionals will mostly take place indoors. In case of outdoor scenarios, risk mitigating measures are implemented to reduce unintended exposure to insignificant amounts. The substance is not supposed to be directly applied to soil. An indirect exposure to soil via sewage sludge transfer is unlikely since the substance is readily biodegradable (for details see IUCLID Ch. 5.2.1). For a substance being considered as „readily biodegradable“, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected. In addition, adsorption to sewage sludge is not expected based on the low adsorption potential (see IUCLID Ch. 5.4.1); therefore, further reducing the risk of indirect transfer of the substance via sewage sludge.
In Annex XI, Section 3, it is laid down that testing in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI, Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are well below 1 for all compartments (see Chemical Safety Report Ch. 10).
Consequently, no tests on soil organisms are performed. The equilibrium partitioning method has been used for assessing the hazard to soil organisms in accordance with Annex IX, Section 9.4, Column 2 of Regulation (EC) No 1907/2006.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- GLP compliance:
- not specified
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- mixture of sewage, soil and natural water
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): mixture from different sources (sewage works, soil, rivers, lakes, sediments)
- Concentration of sludge: 30 mg/L - Duration of test (contact time):
- 14 d
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Parameter followed for biodegradation estimation:
- test mat. analysis
- Remarks:
- (GC)
- Parameter followed for biodegradation estimation:
- TOC removal
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 66.9
- Sampling time:
- 14 d
- Parameter:
- % degradation (TOC removal)
- Value:
- 96.9
- Sampling time:
- 14 d
- Parameter:
- % degradation (test mat. analysis)
- Value:
- 100
- Sampling time:
- 14 d
- Interpretation of results:
- readily biodegradable
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE
OASIS Catalogic v5.14.1.5
2. MODEL (incl. version number)
CATALOGIC 301C v11.16
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
See section 'Test Material'.
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF.
5. APPLICABILITY DOMAIN
See attached QPRF.
6. ADEQUACY OF THE RESULT
- The model is scientifically valid (see attached QMRF).
- The model estimates the biodegradability of a substance Screening information on the ready biodegradability is required for substances manufactured or imported in quantities of 1 t/y or more. Depending on the results, further information may be required for substances manufactured or imported in quantities of 100 t/y or more (simulation testing on ultimate degradation in surface water/soil/sediment). Column 2 of REACH Annex VII provides exemptions for conducting the study. It does not need to be conducted if the substance is inorganic. According to column 2 of REACH Annex IX, testing is not required if the substance is highly insoluble in water, or the substance is readily biodegradable.
- See attached QPRF for reliability assessment. - Principles of method if other than guideline:
- Estimation of ready biodegradation in water using CATALOGIC v5.14.1.5 BOD 28 days MITI (OECD 301C) v11.16
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- other: model calculation
- Duration of test (contact time):
- 28 d
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 72
- St. dev.:
- 0.047
- Sampling time:
- 28 d
- Interpretation of results:
- readily biodegradable
- Remarks:
- according to OECD criteria
Concomitant predictions :
Ready degradable
Primary Half Life = 9.88 days
Ultimate Half Life = 15.18 days
Predicted value (model result): O2 -consumption (BOD) = 0.72 ± 0.0469
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- adsorption / desorption, other
- Remarks:
- adsorption
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable calculation method
- Principles of method if other than guideline:
- Calculation method determining the Koc for charged molecules according to Franco & Trapp (2008, 2009, 2010)
- GLP compliance:
- no
- Type of method:
- other: calculation of log Koc for ionized molecule
- Media:
- soil
- Test temperature:
- 25 °C
- Type:
- Koc
- Value:
- 219 L/kg
- Temp.:
- 25 °C
- Remarks on result:
- other: pH 5 - 8
- Type:
- log Koc
- Value:
- 2.34 dimensionless
- Temp.:
- 25 °C
- Remarks on result:
- other: pH 5 - 8
The data refer to the charged molecule.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.