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Diss Factsheets
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EC number: 219-110-7 | CAS number: 2362-14-3
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because direct and indirect exposure of the aquatic compartment to the substance is unlikely
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Information requirement 9.3.2. (bioaccumulation in aquatic species) is waived on the basis of exposure-based waiving. More specifically - in accordance with Section 3 of REACH Annex XI, testing in accordance with Annex IX and X may be omitted on the basis of substance-tailored exposure-driven testing.
Exposure-based waiving is considered justified based on the following rationale:
• The registrant does not supply the substance (as a reacted monomer in polymers) to the EU and has never supplied the substance in unreacted form to the EU. Furthermore, there are no co-registrants and hence there is currently no substance supply to the EU;
• Previously, the registrant has only ever supplied the substance to the EU in the form of the substance being a reacted monomer in imported polymers. In this historic case, the substance was permanently embedded within the polymer matrix throughout its entire life cycle. Hence, there was no substance release (either to man or the environment) during its past life cycle. Indeed, it would not have been reasonable to expect that there would have been any substance exposure to workers, the general public or the environment following normal and reasonably foreseeable conditions of use. Furthermore, when the substance was previously supplied as a reacted monomer in polymers, the relevant polymers were handled according to the conditions set out in Article 18(4)(a) to (f) during all manufacturing and production stages including the waste management of the substance during these stages;
• The likelihood of depolymerization (and back-formation) of the polymer to the substance monomer is negligible;
• A hypothetical, worst-case exposure based on previous EU use of the polymer demonstrates the absence of or no significant exposure to the registered substance throughout the lifecycle of the polymer. This exposure assessment has been conducted even though the EU supply level for the substance is zero, even though the substance has only ever been supplied as a reacted monomer in previously imported polymers, and even though analysis of residual levels in the previously imported polymer have been determined to be below 0.1 %.
• There have never been any professional or consumer uses of the substance.
A more detailed justification of these points is included in the attached justification document. Please also refer to the various assessment reports as included in section 13.2.
Furthermore, in accordance with section 9.3.2 of Column 2 of REACH Annex IX, it is considered justified to omit the bioaccumulation in aquatic species since direct and indirect exposure of the aquatic compartment is unlikely. Since direct and indirect exposure of the aquatic compartment is unlikely, the use of vertebrate animals to further investigate this endpoint is therefore not considered to be ethical.
Additionally, although the log Kow value is very slightly above the log Kow ≤3 cut-off criterion given in Column 2 (experimental value 3.1), it is considered that the log Kow value is sufficiently low so as to suggest that the substance is not likely to bioaccumulate. Supporting data is also included to help address this endpoint. In a study performed according to OECD Test Guideline 305 C (Cyprinus carpio), 28-day bioconcentration factors (BCFs) of 86 and 73 L/kg were reported when DMBPC was tested at initial aqueous concentrations of 0.01 and 0.001 mg/L, respectively (Iizuka, 2003).
Overall, it is therefore considered justified to omit a study to obtain further information on bioaccumulation in aquatic species as included under section 9.3.2. of REACH Annex IX. - Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Remarks:
- Only Abstract was translated to English so unable to provide/determine study details.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 305 C (Bioaccumulation: Test for the Degree of Bioconcentration in Fish)
- Deviations:
- no
- GLP compliance:
- not specified
- Radiolabelling:
- not specified
- Details on sampling:
- Samples of water and fish were analysed on study days 7, 14, 21, 26 and 28.
- Vehicle:
- not specified
- Details on preparation of test solutions, spiked fish food or sediment:
- no data
- Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- Average body weight: 2.15 ± 0.28 g
Average body length: 5.8 ± 0.4 cm - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 4 wk
- Hardness:
- no data
- Test temperature:
- 25.0 ± 0.7°C
- pH:
- no data
- Dissolved oxygen:
- 6.7 – 7.4 mg/L
- TOC:
- no data
- Salinity:
- no data
- Details on test conditions:
- Test aquarium: Glass aquarium (50 L)
Flow rate: 648 L/day - Nominal and measured concentrations:
- 0.01 and 0.001 mg/L (Nominal)
- Reference substance (positive control):
- not specified
- Details on estimation of bioconcentration:
- no data
- Lipid content:
- 4 %
- Time point:
- start of exposure
- Lipid content:
- 4.2 %
- Time point:
- end of exposure
- Type:
- BCF
- Value:
- 86
- Basis:
- not specified
- Calculation basis:
- steady state
- Remarks on result:
- other: A steady state was established on the 14th day and thereafter
- Remarks:
- Conc.in environment / dose:0.01 mg/L
- Type:
- BCF
- Value:
- 73
- Basis:
- not specified
- Calculation basis:
- steady state
- Remarks on result:
- other: A steady state was established on the 14th day and thereafter
- Remarks:
- Conc.in environment / dose:and 0.001 mg/L
- Details on results:
- Appearance of test fish was normal by aquarium-side observations.
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The steady-state bioconcentration factors of DMBPC (BCF 95) were 86 in Level 1 (0.01 mg/L) and 73 in level 2 (0.001 mg/L).
- Executive summary:
The potential of the test substance to bioaccumulate was investigated in a study conducted in accordance with the standardised guideline OECD 305 C.
DMBPC was tested at initial aqueous concentrations of 0.01 and 0.001 mg/L in common carp (Cyprinus carpio) for 28 days. The test was carried out in freshwater under flow-through conditions at a flow rate of 648 L/day. A steady state was established on the 14th day and thereafter.
Samples of water and fish were analysed on study days 7, 14, 21, 26 and 28. The concentrations of DMBPC were determined by HPLC. The lipid content was determined to be 4 and 4.2 % at the start and end of exposure, respectively.
The steady-state bioconcentration factors of DMBPC (BCF 95) were 86 in Level 1 (0.01 mg/L) and 73 in level 2 (0.001 mg/L). These BCFs indicate that DMBPC has a low potential to bioaccumulate/bioconcentrate.
Referenceopen allclose all
Bioconcentration factors (BCF)
Exposure Level (mg/L) | Exposure period | ||||
7 days | 14 days | 21 days | 26 days | 28 days | |
0.01 | 31 | 101 | 78 | 69 | 90 |
15 | 94 | 95 | 89 | 72 | |
0.001 | 49 | 60 | 71 | 65 | 95 |
31 | 58 | 73 | 73 | 94 |
Description of key information
The endpoint bioaccumulation in aquatic species is waived in accordance with Section 3 of REACH Annex XI (substance-tailored exposure-driven testing) due to a demonstrable lack of exposure to the substance in the EU to either man or the environment.
In accordance with column 2 of REACH Annex IX (information requirement 9.3.2) is additionally waived since direct and indirect exposure of the aquatic compartment is unlikely.
Additionally, although the log Kow value is very slightly above the log Kow ≤3 cut-off criterion given in Column 2 (experimental value 3.1), it is considered that the log Kow value is sufficiently low so as to suggest that the substance is not likely to bioaccumulate. Supporting data is also included to help address this endpoint. In a study performed according to OECD Test Guideline 305 C (Cyprinus carpio), 28-day bioconcentration factors (BCFs) of 86 and 73 L/kg were reported when DMBPC was tested at initial aqueous concentrations of 0.01 and 0.001 mg/L, respectively.
Overall, it is therefore considered justified to omit a study to obtain further information on bioaccumulation in aquatic species as included under section 9.3.2. of REACH Annex IX.
Key value for chemical safety assessment
- BCF (aquatic species):
- 86 L/kg ww
Additional information
In a supporting study performed according to OECD Test Guideline 305 C testing common carp (Cyprinus carpio), 28-d bioconcentration factors (BCFs) of 86 and 73 L/kg were reported when DMBPC was tested at initial aqueous concentrations of 0.01 and 0.001 mg/L, respectively (Institute of Ecotoxicology, Ltd., 2003). These BCFs indicate that DMBPC has a low potential to bioaccumulate/ bioconcentrate. However, the original study report is in Japanese and only the abstract has been provided in English; therefore, a thorough assessment of study reliability could not be completed and the study was awarded a reliability score of 4 in accordance with the criteria set forth by Klimisch et al. (1997). An experimentally-determined log Kow of 3.1 (RCC Ltd., 2001g) supports the conclusion that DMBPC has low potential to bioaccumulate/bioconcentrate.
Taken together, these data support the argument that DMBPC is not bioaccumulative in aquatic/benthic species.
References:
Iizuka, N. 2003. Test on the degree of bioaccumulation of DMBPC in carp, Cyprinus carpio. Testing laboratory: Institute of Ecotoxicology, Ltd., Saitama City, Japan. Report no.: E4 -02030 -D28. Owner company: Anonymous. Report date: 2002 -10 -17.
Tognucci, A. 2001b. Determination of Partition Coefficient (n-Octanol/Water) of DMBPC. Testing laboratory: RCC Ltd., Itingen, Switzerland. Report no.: 798344. Owner company: Anonymous. Report date: 2001-07-05.
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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