Registration Dossier
Registration Dossier
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EC number: 941-216-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Phototransformation in air
No experimental data available. As this study is not a standard information requirement in REACH and there is no indication from the CSA on the need to investigate further the fate and behaviour of the substance (Annex X requirement), no further testing is considered necessary.
Phototransformation in water
No experimental data available. As this study is not a standard information requirement in REACH and there is no indication from the CSA on the need to investigate further the fate and behaviour of the substance (Annex X requirement), no further testing is considered necessary.
Phototransformation in soil
No experimental data available. As this study is not a standard information requirement in REACH and there is no indication from the CSA on the need to investigate further the fate and behaviour of the substance (Annex X requirement), no further testing is considered necessary.
Hydrolysis
Based on the low measured water solubility (0.2 mg/l), it can be concluded that Cashew Nutshell Extract, Decarboxylated (Technical Grade) is not expected to be hydrolysed. There are no functional groups or other structural alerts present that would indicate that this substance would be sensitive to hydrolysis by water under any pH conditions.
Biodegradation in water
In a robust OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test) Cashew Nutshell Extract, Decarboxylated (Technical Grade) 69.3% of the test substance was degraded within 28 days. The profile of the biodegradation for the test substance when enhanced with Tween surfactant and a GF/C paper support was increased by about 14% (to 69.3%), and exceeded the 60% threshold after 28 days. Using the surface area enhancement measures as described, Technical Grade is considered to be ultimately (inherently) biodegradable. However, it should be noted that as the test substance is a mixture, different rates of degradation may occur under realistic conditions.
Biodegradation in Water and Sediment
Based on Epiwin V3.12 Level III Fugacity Model estimations, the major low molecular weight components of Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade) which are cardanol and cardol (see Section 1.2) will distribute almost exclusively to sediment (94.8 – 97.3%) if released to water.
Biogradation in Soil
Based on Epiwin V3.12 Level III Fugacity Model estimations, the major low molecular weight components of Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade) which are cardanol and cardol (see Section 1.2) will distribute almost exclusively to soil if released to soil.
Bioaccumulation: aquatic /sediment
The effect values for the bioaccumulation in aquatic species (fish) endpoint for the target substance Technical Grade have been generated by interpolation from the experimental test data on the source substances Distilled and Distillation Residue Grades. In this context interpolation is considered to be the ‘estimation of a value for a member of the group using measured values from other members on both sides of that member within the defined group spectrum’ (ECHA 2008: Guidance on information requirements and chemical safety assessment. Chapter R.6: QSARs and grouping of chemicals).
The interpretation of the data for the bioaccumulation in aquatic species endpoint has been complicated by the fact that the OECD TG305 study on Distilled Grade used an aqueous exposure route and generated Bioconcentration Factors (BCFs) for the different forms of cardanol (i.e. monoene, diene, triene and saturated side chain) measured. In contrast, the dietary route had to be used in the corresponding study on Distillation Residue Grade due to technical problems in conducting the test via an aqueous exposure route. However, it was possible to generate estimated BCFs values from the data from the dietary exposure study.
For Distilled Grade the Bioconcentration Factors (BCFs) for the four different forms of cardanol (monoene, diene, triene and saturated side chain) in the UVCB showed that accumulation in fish was always below 900 L/kg at each sampling point (Days 1, 3, 7, 14, 21 and 28). Due to the low levels of accumulation during uptake no depuration phase was conducted. Since the individual BCF values obtained, both before and after lipid normalisation, were below the threshold value of 2000 L/kg in all cases Distilled Grade is not considered to be bioaccumulative.
For Distillation Residue Grade dietary Biomagnification Factors (BMFs) and overall depuration rate (k2) constants were derived for the three forms of cardanol measured. Bioconcentration Factors (BCFs) were also derived using the data generated in the study. The tentative BCF values (L/kg) derived from the study (based on the methods of Brooke and Crookes, 2012 and Inoue et al 2012) were 837-893, 414-478 and 280-362 for the monoene, diene and triene forms of cardanol respectively. These values are significantly below the 2000 L/Kg threshold for a substance to be considered to be bioaccumulative. The estimated BCF values (L/kg) for the different forms of cardanol based on the k2 values (and the Brooke and Crookes, 2012 method) are 672, 333 and 245 for the monoene, diene and triene forms of cardanol respectively. These results also indicate that the different forms of cardanol (monoene, diene and triene) did not markedly bioaccumulate and were significantly below the 2000 L/Kg threshold. As a result the test substance Distillation Residue Grade is not considered to be bioaccumulative. The estimated BCF values for the different forms of cardanol in the dietary study are consistent with those from the Distilled Grade study carried out via the aqueous exposure route.
On the basis of the data generated in the studies on Distilled and Distillation Residue Grade for the different forms of cardanol the test substance Technical Grade is not considered to be bioaccumulative.
Adsorption/Desorption
The soil adsorption coefficient (logKoc) of the test substance Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade) was determined to be 4.4 - 5.7 by the HPLC estimation method according to guideline OECD Guideline 121 (Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC)).
Henry’s Law Constant
Reliable results for Henry’s Law Constant of 0 atm m³/mol for key components of Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade) have been generated from a recognised model (US EPA EpiWin version 3.12). This data is not required under REACH, but is included as additional information.
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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