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EC number: 305-516-2 | CAS number: 94581-17-6
- 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
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Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: sediment simulation testing
- Type of information:
- other: Assessment report QSAR and Experimental data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- The rosin adduct ester category consists of fumarated and maleated esters of glycerol and pentaerythritol. The substances consist of ester constituents (mono-, di- and tri- glycerol esters and mono-, di-, tri- and tetra- pentaerythritol esters), and free resin acids. Standard biodegradation studies are not really appropriate for whole substance UVCBs and therefore as much is reasonably practicable, biodegradation of the individual consituents as a whole needs to be considered. In order to prioritise the consituents that may require further testing a PBT screening assessment of Rosin Adducts and Rosin Adducts Salts substances was undertaken. The logic being that if a consituent is both Persistent and Bioaccumulative then further testing on these constituents would be required.
Guidance for mono-constituents is available from ECHA; however, for complex substances such as Unknown or Variable Composition, Complex reaction products or Biological materials (UVCBs) there is currently little guidance on how the PBT/vPvB assessment should be conducted. A pragmatic approach for UVCBs is to evaluate all the individual constituents present in the substance at a concentration of ≥0.1% for their PBT properties.
As this is a UVCB substance it is not possible to identify every single constituent at a concentration of 0.1% (which numbers thousands)and detailed analysis of each individual constituent within the substance is not available. As such, a list of representative constituents has been developed from information in the Substance Identity Profiles. All identified representative constituents were assessed individually for their P and B properties.
Any constituents that are both P and B will be taken forward for further simulation studies. - Qualifier:
- no guideline required
- Principles of method if other than guideline:
- A Tiered approach to screening for the substance's PBT properties was employed. The Tiered approach adopted aims to screen the constituents based on their P and B properties using available data. Those constituents that are identified as being potentially P/vP and B/vB are then taken for further assessment of their PBT/vPvB properties.
Persistence
To assess the probability that each constituent is Persistent or not, QSAR models and any readily available experimental data has been used. Experimental data has been given the highest priority over QSARs and where available conclusions have been drawn on available experimental data. QSAR data on the probability for persistence was modelled using BIOWIN 4.10 models (BIOWIN 2, BIOWIN 3, BIOWIN 6) (USEPA, 2012).
Bioaccumulation
First the log Kow and Koa of each constituent was estimated using KOWWIN and KOAWIN models (USEPA, 2012). This database also provided some experimental Log Kow/Log Koa values. The log Kow and the log Koa were used as a first screen to conclude if a constituent was not B/vB.
The guidelines suggest that substances with a log Kow of >10 and/or an average maximum diameter (Dmaxav) of >1.7 nm are less likely to be bioavailable due to their very large molecular size and inability to cross biological membranes. This data has been included in the assessment to increase confidence that a constituent is unlikely to be bioaccumulative. Constituents with these characteristics are also considered to be not B for air-breathing organisms.
In addition to any readily available experimental data predicted BCFs using the BCFBAF regression model based on log Kow and the Arnot-Gobas (upper trophic) model were derived for each constituent. The BCFBAF regression model is considered a lower tier model compared to the Arnot-Gobas (upper trophic) model. The BCFBAF model uses the log Kow and a regression equation to predict the BCF of the substance and can be used for ionic and non-ionic substances. - GLP compliance:
- no
- Inoculum or test system:
- not specified
- Parent/product:
- parent
- Remarks on result:
- not measured/tested
- Transformation products:
- not measured
- Conclusions:
- Following the Screening assessment detailed above the data gathered suggests that whilst conclusions on Persistence cannot be drawn for the constituents where data are from QSARs alone, none of the constituents are expected to be Bioaccumulative. Five of the constituents were found to be not P based on experimental data these correspond to 4 of the constiuents that were identified as being potentially B/vB, these are therefore not considered PBT or PvB. It is noted that, even if the data on bioaccumulation is exclusively from QSARs for this substance, the models used are reliable, well documented and well known and fit these types of constituents, even those substances that have a higher Kow than the training data set. The Predicted BCF values in both models were much lower than the 2000 L/kg criterion for B in the Regulation and therefore there is high confidence that there are no constituents of concern in this substance. Therefore, no simulation studies are required on any constituents in this substance.
- Executive summary:
The rosin adduct ester category consists of fumarated and maleated esters of glycerol and pentaerythritol. The substances consist of ester constituents (mono-, di- and tri- glycerol esters and mono-, di-, tri- and tetra- pentaerythritol esters), and free resin acids. Standard biodegradation studies are not really appropriate for whole substance UVCBs and therefore as much is reasonably practicable, biodegradation of the individual consituents as a whole needs to be considered. In order to prioritise the consituents that may require further testing a PBT screening assessment of Rosin Adducts and Rosin Adducts Salts substances was undertaken. The logic being that if a consituent is both Persistent and Bioaccumulative then further testing on these constituents would be required.
Guidance for mono-constituents is available from ECHA; however, for complex substances such as Unknown or Variable Composition, Complex reaction products or Biological materials (UVCBs) there is currently little guidance on how the PBT/vPvB assessment should be conducted. A pragmatic approach for UVCBs is to evaluate all the individual constituents present in the substance at a concentration of ≥0.1% for their PBT properties.
As this is a UVCB substance it is not possible to identify every single constituent at a concentration of 0.1% (which numbers thousands)and detailed analysis of each individual constituent within the substance is not available. As such, a list of representative constituents has been developed from information in the Substance Identity Profiles. All identified representative constituents were assessed individually for their P and B properties.
Any constituents that are both P and B will be taken forward for further simulation studies.
Following the Screening assessment detailed above the data gathered suggests that whilst conclusions on Persistence cannot be drawn for the constituents where data are from QSARs alone, none of the constituents are expected to be Bioaccumulative. Five of the constituents were found to be not P based on experimental data these correspond to 4 of the constiuents that were identified as being potentially B/vB, these are therefore not considered PBT or PvB. It is noted that, even if the data on bioaccumulation is exclusively from QSARs for this substance, the models used are reliable, well documented and well known and fit these types of constituents, even those substances that have a higher Kow than the training data set. The Predicted BCF values in both models were much lower than the 2000 L/kg criterion for B in the Regulation and therefore there is high confidence that there are no constituents of concern in this substance. Therefore, no simulation studies are required on any constituents in this substance.
- Endpoint:
- biodegradation in water: simulation testing on ultimate degradation in surface water
- Type of information:
- other: Assessment report QSAR and Experimental data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- The rosin adduct ester category consists of fumarated and maleated esters of glycerol and pentaerythritol. The substances consist of ester constituents (mono-, di- and tri- glycerol esters and mono-, di-, tri- and tetra- pentaerythritol esters), and free resin acids. Standard biodegradation studies are not really appropriate for whole substance UVCBs and therefore as much is reasonably practicable, biodegradation of the individual consituents as a whole needs to be considered. In order to prioritise the consituents that may require further testing a PBT screening assessment of Rosin Adducts and Rosin Adducts Salts substances was undertaken. The logic being that if a consituent is both Persistent and Bioaccumulative then further testing on these constituents would be required.
Guidance for mono-constituents is available from ECHA; however, for complex substances such as Unknown or Variable Composition, Complex reaction products or Biological materials (UVCBs) there is currently little guidance on how the PBT/vPvB assessment should be conducted. A pragmatic approach for UVCBs is to evaluate all the individual constituents present in the substance at a concentration of ≥0.1% for their PBT properties.
As this is a UVCB substance it is not possible to identify every single constituent at a concentration of 0.1% (which numbers thousands)and detailed analysis of each individual constituent within the substance is not available. As such, a list of representative constituents has been developed from information in the Substance Identity Profiles. All identified representative constituents were assessed individually for their P and B properties.
Any constituents that are both P and B will be taken forward for further simulation studies. - Qualifier:
- no guideline required
- Principles of method if other than guideline:
- A Tiered approach to screening for the substance's PBT properties was employed. The Tiered approach adopted aims to screen the constituents based on their P and B properties using available data. Those constituents that are identified as being potentially P/vP and B/vB are then taken for further assessment of their PBT/vPvB properties.
Persistence
To assess the probability that each constituent is Persistent or not, QSAR models and any readily available experimental data has been used. Experimental data has been given the highest priority over QSARs and where available conclusions have been drawn on available experimental data. QSAR data on the probability for persistence was modelled using BIOWIN 4.10 models (BIOWIN 2, BIOWIN 3, BIOWIN 6) (USEPA, 2012).
Bioaccumulation
First the log Kow and Koa of each constituent was estimated using KOWWIN and KOAWIN models (USEPA, 2012). This database also provided some experimental Log Kow/Log Koa values. The log Kow and the log Koa were used as a first screen to conclude if a constituent was not B/vB.
The guidelines suggest that substances with a log Kow of >10 and/or an average maximum diameter (Dmaxav) of >1.7 nm are less likely to be bioavailable due to their very large molecular size and inability to cross biological membranes. This data has been included in the assessment to increase confidence that a constituent is unlikely to be bioaccumulative. Constituents with these characteristics are also considered to be not B for air-breathing organisms.
In addition to any readily available experimental data predicted BCFs using the BCFBAF regression model based on log Kow and the Arnot-Gobas (upper trophic) model were derived for each constituent. The BCFBAF regression model is considered a lower tier model compared to the Arnot-Gobas (upper trophic) model. The BCFBAF model uses the log Kow and a regression equation to predict the BCF of the substance and can be used for ionic and non-ionic substances. - GLP compliance:
- no
- Inoculum or test system:
- not specified
- Parent/product:
- parent
- Remarks on result:
- not measured/tested
- Transformation products:
- not measured
- Conclusions:
- Following the Screening assessment detailed above the data gathered suggests that whilst conclusions on Persistence cannot be drawn for the constituents where data are from QSARs alone, none of the constituents are expected to be Bioaccumulative. Five of the constituents were found to be not P based on experimental data these correspond to 4 of the constiuents that were identified as being potentially B/vB, these are therefore not considered PBT or PvB. It is noted that, even if the data on bioaccumulation is exclusively from QSARs for this substance, the models used are reliable, well documented and well known and fit these types of constituents, even those substances that have a higher Kow than the training data set. The Predicted BCF values in both models were much lower than the 2000 L/kg criterion for B in the Regulation and therefore there is high confidence that there are no constituents of concern in this substance. Therefore, no simulation studies are required on any constituents in this substance.
- Executive summary:
The rosin adduct ester category consists of fumarated and maleated esters of glycerol and pentaerythritol. The substances consist of ester constituents (mono-, di- and tri- glycerol esters and mono-, di-, tri- and tetra- pentaerythritol esters), and free resin acids. Standard biodegradation studies are not really appropriate for whole substance UVCBs and therefore as much is reasonably practicable, biodegradation of the individual consituents as a whole needs to be considered. In order to prioritise the consituents that may require further testing a PBT screening assessment of Rosin Adducts and Rosin Adducts Salts substances was undertaken. The logic being that if a consituent is both Persistent and Bioaccumulative then further testing on these constituents would be required.
Guidance for mono-constituents is available from ECHA; however, for complex substances such as Unknown or Variable Composition, Complex reaction products or Biological materials (UVCBs) there is currently little guidance on how the PBT/vPvB assessment should be conducted. A pragmatic approach for UVCBs is to evaluate all the individual constituents present in the substance at a concentration of ≥0.1% for their PBT properties.
As this is a UVCB substance it is not possible to identify every single constituent at a concentration of 0.1% (which numbers thousands)and detailed analysis of each individual constituent within the substance is not available. As such, a list of representative constituents has been developed from information in the Substance Identity Profiles. All identified representative constituents were assessed individually for their P and B properties.
Any constituents that are both P and B will be taken forward for further simulation studies.
Following the Screening assessment detailed above the data gathered suggests that whilst conclusions on Persistence cannot be drawn for the constituents where data are from QSARs alone, none of the constituents are expected to be Bioaccumulative. Five of the constituents were found to be not P based on experimental data these correspond to 4 of the constiuents that were identified as being potentially B/vB, these are therefore not considered PBT or PvB. It is noted that, even if the data on bioaccumulation is exclusively from QSARs for this substance, the models used are reliable, well documented and well known and fit these types of constituents, even those substances that have a higher Kow than the training data set. The Predicted BCF values in both models were much lower than the 2000 L/kg criterion for B in the Regulation and therefore there is high confidence that there are no constituents of concern in this substance. Therefore, no simulation studies are required on any constituents in this substance.
Referenceopen allclose all
Tier 1 Screening
Persistence
There is an OECD 301B ready biodegradation study available for Abietal which is one of the Neutral Fraction Aldehydes which showed that Abietal is not persistent. This data can be read-across to the other Neutral Aldehydes and therefore these are not considered persistent (CRL, 2021). The persistence assessment of the other constituents relies on the BIOWIN QSARs. Five of the 48 constituents have therefore been identified in experimental studies to be “Not P”.
This data indicates that a further nine of the 48 constituents are Predicted not P and the remaining 34 constituents are Predicted P.
Results for Screening of P
P conclusion |
Number of Constituents that met the criterion |
Not P |
5 of 48 |
Predicted Not P |
9 of 48 |
Predicted P |
34 of 48 |
P |
0 of 48 |
vP |
0 of 48 |
Bioaccumulation
Of the 48 constituents, none could be omitted from further assessment as they were identified as Potentially B and require further assessment. It is noted that the 48 constituents were screened as potentially B since they presented a log Kow >2 and a log Koa >5, which indicates bioaccumulation in air-breathing organisms. All constituents were also screened Potentially B for aquatic organisms due to having a log Kow >4.5. See Appendix 3 for exact values. As suggested above, further assessment of the risk of bioaccumulation in air breathing organisms cannot be assessed competently at present with the heavy information burden that would be required for each of these 48 constituents. Further assessment will therefore be based on aquatic organisms only.
Results for Screening of B
B conclusion |
Number of Consituents that met the criteria |
Not B |
0 of 48 |
Potentially B/vB - needs further assessment |
48 of 48 |
Tier 2 Assessment
Persistence
Without further experimental data on the constituents assessment of Persistence is not viable. As such the bioaccumulation assessment using QSARs was undertaken first to identify any specific constituents that may need further data on their persistence to be sought.
Bioaccumulation
Measured BCF values have been obtained for nine resin acids (abietic, dehydroabietic, chlorodehydroabietic, dichlorodehydroabietic, neoabietic, pimaric, isopimaric, sandaracopimaric and palustric acids), from a bioaccumulation study with Oncorhynchus mykiss. This study reported a range of BCFs between 23 and 129 (Niimi and Lee 1992). In this study, fish that were exposed to mean waterborne concentrations of 0.7 to 3.6 µg/L for 20 days, followed by a 10-day depuration period. No detectable levels of free or conjugated acids were found in fish sampled 4 to 10 days into the depuration period, therefore no half-lives could be calculated. However, based on initial chemical concentrations, it was suggested that the half-lives of these acids were <4 days.
Burggraaf et al. (1996) determined BCF values for mussels (Hyridella menziesi) exposed to effluent from a pulp and paper mill. Concentrations of resin acids (pimaric acid, isopimaric acid, dehydroabietic acid, abietic acid and 14 -chlorodehydroabietic acid) were analysed in mussels and in the effluent for a 28d exposure phase, followed by a 21d depuration phase. BCF values for the individual resin acids ranged from 110 to 330 L/kg. The BCF values determined in these studies are far below the bioaccumulation threshold, therefore resin acids are not considered to be bioaccumulative.
QSAR models were therefore used to fill the remaining data gaps for the constituents in this assessment. Of the 48 constituents that required further assessment, seven had experimental data that showed that they were not bioaccumulative. Four of the constituents (Neutral Aldehydes) were predicted to potentially be B/vB. The remaining constituents all reported BCFs <2000 L/kg. As a result, 37 of the 48 constituents were concluded to be Predicted Not B.
Results from Tier 2 assessment
B conclusion |
Number ofConstituents that met the criterion |
Not B |
7 of 48 |
Predicted Not B |
37 of 48 |
Predicted B |
4 of 48 |
Predicted vB |
0 of 48 |
B |
0 of 48 |
vB |
0 of 48 |
Conclusion on Persistence and Bioaccumulation
Following the Screening assessment detailed above the data gathered suggests that whilst conclusions on Persistence cannot be drawn for the constituents where data are from QSARs alone, none of the constituents are expected to be Bioaccumulative. Five of the constituents were found to be not P based on experimental data these correspond to 4 of the constiuents that were identified as being potentially B/vB, these are therefore not considered PBT or PvB. It is noted that, even if the data on bioaccumulation is exclusively from QSARs for this substance, the models used are reliable, well documented and well known and fit these types of constituents, even those substances that have a higher Kow than the training data set. The Predicted BCF values in both models were much lower than the 2000 L/kg criterion for B in the Regulation and therefore there is high confidence that there are no constituents of concern in this substance. Therefore, no simulation studies are required on any constituents in this substance.
Final conclusion
PBT conclusion |
Number of Constituents that met the criterion |
Not PBT/vPvB |
48 of 48 |
Potentially PBT |
0 of 48 |
Potentially vPvB |
0 of 48 |
Tier 1 Screening
Persistence
There is an OECD 301B ready biodegradation study available for Abietal which is one of the Neutral Fraction Aldehydes which showed that Abietal is not persistent. This data can be read-across to the other Neutral Aldehydes and therefore these are not considered persistent (CRL, 2021). The persistence assessment of the other constituents relies on the BIOWIN QSARs. Five of the 48 constituents have therefore been identified in experimental studies to be “Not P”.
This data indicates that a further nine of the 48 constituents are Predicted not P and the remaining 34 constituents are Predicted P.
Results for Screening of P
P conclusion |
Number of Constituents that met the criterion |
Not P |
5 of 48 |
Predicted Not P |
9 of 48 |
Predicted P |
34 of 48 |
P |
0 of 48 |
vP |
0 of 48 |
Bioaccumulation
Of the 48 constituents, none could be omitted from further assessment as they were identified as Potentially B and require further assessment. It is noted that the 48 constituents were screened as potentially B since they presented a log Kow >2 and a log Koa >5, which indicates bioaccumulation in air-breathing organisms. All constituents were also screened Potentially B for aquatic organisms due to having a log Kow >4.5. See Appendix 3 for exact values. As suggested above, further assessment of the risk of bioaccumulation in air breathing organisms cannot be assessed competently at present with the heavy information burden that would be required for each of these 48 constituents. Further assessment will therefore be based on aquatic organisms only.
Results for Screening of B
B conclusion |
Number of Consituents that met the criteria |
Not B |
0 of 48 |
Potentially B/vB - needs further assessment |
48 of 48 |
Tier 2 Assessment
Persistence
Without further experimental data on the constituents assessment of Persistence is not viable. As such the bioaccumulation assessment using QSARs was undertaken first to identify any specific constituents that may need further data on their persistence to be sought.
Bioaccumulation
Measured BCF values have been obtained for nine resin acids (abietic, dehydroabietic, chlorodehydroabietic, dichlorodehydroabietic, neoabietic, pimaric, isopimaric, sandaracopimaric and palustric acids), from a bioaccumulation study with Oncorhynchus mykiss. This study reported a range of BCFs between 23 and 129 (Niimi and Lee 1992). In this study, fish that were exposed to mean waterborne concentrations of 0.7 to 3.6 µg/L for 20 days, followed by a 10-day depuration period. No detectable levels of free or conjugated acids were found in fish sampled 4 to 10 days into the depuration period, therefore no half-lives could be calculated. However, based on initial chemical concentrations, it was suggested that the half-lives of these acids were <4 days.
Burggraaf et al. (1996) determined BCF values for mussels (Hyridella menziesi) exposed to effluent from a pulp and paper mill. Concentrations of resin acids (pimaric acid, isopimaric acid, dehydroabietic acid, abietic acid and 14 -chlorodehydroabietic acid) were analysed in mussels and in the effluent for a 28d exposure phase, followed by a 21d depuration phase. BCF values for the individual resin acids ranged from 110 to 330 L/kg. The BCF values determined in these studies are far below the bioaccumulation threshold, therefore resin acids are not considered to be bioaccumulative.
QSAR models were therefore used to fill the remaining data gaps for the constituents in this assessment. Of the 48 constituents that required further assessment, seven had experimental data that showed that they were not bioaccumulative. Four of the constituents (Neutral Aldehydes) were predicted to potentially be B/vB. The remaining constituents all reported BCFs <2000 L/kg. As a result, 37 of the 48 constituents were concluded to be Predicted Not B.
Results from Tier 2 assessment
B conclusion |
Number ofConstituents that met the criterion |
Not B |
7 of 48 |
Predicted Not B |
37 of 48 |
Predicted B |
4 of 48 |
Predicted vB |
0 of 48 |
B |
0 of 48 |
vB |
0 of 48 |
Conclusion on Persistence and Bioaccumulation
Following the Screening assessment detailed above the data gathered suggests that whilst conclusions on Persistence cannot be drawn for the constituents where data are from QSARs alone, none of the constituents are expected to be Bioaccumulative. Five of the constituents were found to be not P based on experimental data these correspond to 4 of the constiuents that were identified as being potentially B/vB, these are therefore not considered PBT or PvB. It is noted that, even if the data on bioaccumulation is exclusively from QSARs for this substance, the models used are reliable, well documented and well known and fit these types of constituents, even those substances that have a higher Kow than the training data set. The Predicted BCF values in both models were much lower than the 2000 L/kg criterion for B in the Regulation and therefore there is high confidence that there are no constituents of concern in this substance.
Final conclusion
PBT conclusion |
Number of Constituents that met the criterion |
Not PBT/vPvB |
48 of 48 |
Potentially PBT |
0 of 48 |
Potentially vPvB |
0 of 48 |
Description of key information
The rosin adduct ester category consists of fumarated and maleated esters of glycerol and pentaerythritol. The substances consist of ester constituents (mono-, di- and tri- glycerol esters and mono-, di-, tri- and tetra- pentaerythritol esters), and free resin acids. Standard biodegradation studies are not really appropriate for whole substance UVCBs and therefore as much is reasonably practicable, biodegradation of the individual consituents as a whole needs to be considered. In order to prioritise the consituents that may require further testing a PBT screening assessment of Rosin Adducts and Rosin Adducts Salts substances was undertaken. The logic being that if a consituent is both Persistent and Bioaccumulative then further testing on these constituents would be required.
Guidance for mono-constituents is available from ECHA; however, for complex substances such as Unknown or Variable Composition, Complex reaction products or Biological materials (UVCBs) there is currently little guidance on how the PBT/vPvB assessment should be conducted. A pragmatic approach for UVCBs is to evaluate all the individual constituents present in the substance at a concentration of ≥0.1% for their PBT properties.
As this is a UVCB substance it is not possible to identify every single constituent at a concentration of 0.1% (which numbers thousands)and detailed analysis of each individual constituent within the substance is not available. As such, a list of representative constituents has been developed from information in the Substance Identity Profiles. All identified representative constituents were assessed individually for their P and B properties.
Any constituents that are both P and B will be taken forward for further simulation studies.
Following the Screening assessment detailed above the data gathered suggests that whilst conclusions on Persistence cannot be drawn for the constituents where data are from QSARs alone, none of the constituents are expected to be Bioaccumulative. Five of the constituents were found to be not P based on experimental data these correspond to 4 of the constiuents that were identified as being potentially B/vB, these are therefore not considered PBT or PvB. It is noted that, even if the data on bioaccumulation is exclusively from QSARs for this substance, the models used are reliable, well documented and well known and fit these types of constituents, even those substances that have a higher Kow than the training data set. The Predicted BCF values in both models were much lower than the 2000 L/kg criterion for B in the Regulation and therefore there is high confidence that there are no constituents of concern in this substance. Therefore, no simulation studies are required on any constituents in this substance.
Key value for chemical safety assessment
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.
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.
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