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EC number: 608-209-4 | CAS number: 284461-73-0
- 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
Biodegradation in soil
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in soil: simulation testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct 2009 - Mar 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- In this study transformation pathways and transformation rates were determined in one representative soil. According to OECD 307 aerobic and anaerobic studies with one soil type are generally sufficient for the evaluation of transformation pathways while rates of transformation should be determined in at least three additional soils. The representative soil was determined to be microbially viable throughout the study and the dissipation time of the test substance was 187 d at 20 °C which corresponds to 397 d at 12°C (which is the relevant temperature for evaluations under REACH). This values clearly indicate that the test substance is highly persistent in soil (>120 d for the P and > 180 d for the vP criteria) and the dissipation time is not assumed to substantially deviate for other soil types. Based on this, additional measures on soil type and temperature would not influence the outcome of the study regarding the biodegradation behavior of the test substance in soil. Therefore, the results from this study are considered reliable with restrictions.
- Justification for type of information:
- Sorafenib Tosylate was used as an analogue.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 307 (Aerobic and Anaerobic Transformation in Soil)
- Deviations:
- yes
- Remarks:
- One representative soil was used within the study. For details, please see 'Rationale for reliability incl. deficiencies'
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- laboratory
- Radiolabelling:
- yes
- Oxygen conditions:
- aerobic
- Soil classification:
- USDA (US Department of Agriculture)
- Soil no.:
- #1
- Soil type:
- sandy loam
- % Clay:
- 10.3
- % Silt:
- 31.5
- % Sand:
- 58.2
- % Org. C:
- 2.21
- pH:
- 7.1
- CEC:
- 12.6
- Soil No.:
- #1
- Duration:
- 120 d
- Soil No.:
- #1
- Initial conc.:
- 1 000 other: ug/kg dry soil
- Based on:
- test mat.
- Parent/product:
- parent
- Soil No.:
- #1
- % Degr.:
- 31.7
- Parameter:
- radiochem. meas.
- Sampling time:
- 120 d
- Key result
- Soil No.:
- #1
- DT50:
- 397 d
- Type:
- (pseudo-)first order (= half-life)
- Temp.:
- 12 °C
- Remarks on result:
- other: Value according to temperature correction by using the Arrhenius equation with the generic Ea-value (ECHA Guidance R.7b)
- Soil No.:
- #1
- DT50:
- 187 d
- Type:
- (pseudo-)first order (= half-life)
- Temp.:
- 20 °C
- Remarks on result:
- other: DT75=375; DT90=622 d
- Transformation products:
- not specified
- Details on transformation products:
- In the soil an average of 103% of the applied radioactivity was extractable on day 0. Thereafter, the extractable residue in the soil decreased steadily to an average of 66.4% at day 120. The nonextractable radioactivity increased continuously from an average of 1.4% at test start to an average of 31.7% at day 120. HPLC analysis of the extracts showed that all extractable radioactivity consisted of [14C]BAY 54-9085.
- Conclusions:
- The DT50 of [14C] BAY 54-9085 in the aerobic sandy loam soil Sevelen was calculated to be 187 days. The soil was determined to be microbially viable throughout the study. No major metabolites were detected and only minor mineralization to CO2 was observed throughout the study.
The degradation of [14C] BAY 54-9085 is accompanied by increasing levels of non-extractable residues in soil. Overall, [14C] BAY 54-9085 is only slowly degraded in soil under aerobic conditions. - Executive summary:
This study about aerobic rate of degradation in soil is intended to provide information on: (1) the route of degradation (transformation pathway) of the parent compound in one representative soil, and (2) the nature and rate of formation and decline of transformation products. In one representative soil an average of 103% of the applied radioactivity was extractable on day 0. Thereafter, the extractable residue in the soil decreased steadily to an average of 66.4% at day 120. The non-extractable radioactivity increased constantly from an average of 1.4% at test start to an average of 31.7% at day 120. HPLC analysis of the extracts showed that all extractable radioactivity consisted of [14C] BAY 54-9085. No volatile organic compounds were found in the ethylene glycol traps throughout the study. The 14CO2 measured in the KOH traps increased from an average of 0.01% on day 3 to an average of 0.54% on day 120. The DT50, DT75 and DT90 of the parent compound were calculated to be 187, 375 and 622 days at 20°C, respectively. The biomass was determined to be 1.3, 1.0 and 0.8% of the organic carbon content at test start, mid-study and test end respectively.
In this study transformation pathways and transformation rates were determined in one representative soil. According to OECD 307 aerobic and anaerobic studies with one soil type are generally sufficient for the evaluation of transformation pathways while rates of transformation should be determined in at least three additional soils. The representative soil was determined to be microbially viable throughout the study and the dissipation time of the test substance was 187 d at 20 °C which corresponds to 397 d at 12°C (which is the relevant temperature for evaluations under REACH). This values clearly indicate that the test substance is highly persistent in soil (>120 d for the P and > 180 d for the vP criteria) and the dissipation time is not assumed to substantially deviate for other soil types. Based on this, additional measures on soil type and temperature would not influence the outcome of the study regarding the biodegradation behavior of the test substance in soil. Therefore, the results from this study are considered reliable with restrictions.
Reference
In the soil an average of 103% of the applied radioactivity
was extractable on day 0. Thereafter, the extractable residue
in the soil decreased steadily to an average of 66.4% at day
120. The non-extractable radioactivity increased constantly
from an average of 1.4% at test start to an average of 31.7%
at day 120.
HPLC analysis of the extracts showed that all extractable
radioactivity consisted of [14C]BAY 54-9085.
No volatile organic compounds were found in the ethylene
glycol traps throughout the study. The 14CO2 measured in
the KOH traps increased from an average of 0.01% on day 3
to an average of 0.54% on day 120
The DT50, DT75 and DT90 of the parent compound were
calculated to be 187, 375 and 622 days, respectively.
The biomass was determined to be 1.3, 1.0 and 0.8% of the
organic carbon content at test start, mid-study and test end
respectively.
Description of key information
A guideline study according to OECD 307 (Aerobic and anaerobic Transformation in soil) under GLP was conducted to assess the biodegradation of [14C]BAY 54-9085 in soil. This study about aerobic rate of degradation in soil is intended to provide information on: (1) the route of degradation (transformation pathway) of the parent compound in one representative soil, (2) the nature and rate of formation and decline of transformation products. The soil was exposed to a nominal test concentration of 1000 µg/kg soil dw. HPLC analysis of the extracts showed that all extractable radioactivity consisted of [14C]BAY 54-9085. No volatile organic compounds were found in the ethylene glycol traps throughout the study. No major metabolites were detected and only minor mineralization to CO2 was observed throughout the study. The degradation of the test substance is accompanied by increasing levels of non-extractable residues in soil. The DT50, DT75 and DT90 of the test substance in aerobic sandy loam soil Sevelen were calculated to be 187, 375 and 622 days, respectively. This corresponds to a DT50 value of 397 days at 12°C (which is the relevant temperature for evaluations under REACH). Overall, the test substance is only slowly degraded in soil under aerobic conditions.
Key value for chemical safety assessment
- Half-life in soil:
- 397 d
- at the temperature of:
- 12 °C
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.
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