Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - dermal (%):
100

Additional information

For the assessment of toxicokinetics, metabolism and distribution the read across substance is Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (“Distilled Grade”). A document which justifies the read–across from Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (“Distilled Grade”) to Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distillation Residue (“Distilled Residue Grade”) is attached.

Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (“Distilled Grade”) has a higher proportion of lower molecular weight, more potentially toxicologically active components, (principally cardanol) and lower proportion of more inert polymeric species compared to Distillation Residue Grade. The relative typical proportions of the cardanol and polymeric species in Distilled and Distillation Residue Grades are 78% versus 35% and 2% versus 50% respectively. Therefore, it is considered that distilled grade has the potential to exert greater toxicity within the group of distilled, technical and distilled residue grades (see Section 3.1 - Technological Process) for endpoints relevant to human health and environmental effects. On this basis within the group of distilled, technical and distilled residue grades, the substance Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled represents the potentially most (eco)toxicologically active form.

Systemic effects following repeated dosing indicate that Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is absorbed via the gastro-intestinal tract. The rate and extent of absorption cannot be elucidated from the data available. Local effects only were observed from an acute dermal toxicity study, and also a skin irritation and sensitisation studies. Therefore, an indication of absorption has been observed from the sensitisation study. It is likely that the skin barrier will be compromised by the irritation/sensitisation observed following application of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade), and that some absorption via this route will occur. No data are available on exposure via inhalation.

Systemic effects in the lung, mesenteric lymph nodes, stomach and duodenum were observed, indicating that Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is distributed throughout the body, however, the extent of such distribution is unknown.

No data are available to conclude on the metabolism of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade).

No data are available to conclude on the excretion rate, extent and pathways of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade).

Discussion on absorption rate:

The rate and extent of absorption cannot be elucidated from the data available. Local effects only were observed from an acute dermal toxicity study, and also a skin irritation and sensitisation studies. Therefore, some absorption must occur to induce sensitisation. It is likely that the skin barrier will be compromised by the irritation/sensitisation observed following application of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade), and that some absorption via this route will occur. No data are available on exposure via inhalation. A default of 100% has been calculated, due to the irritant properties of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade), even though it has high molecular weight and a log POW>4. This value is considered to be precautionary for Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distilled Residue Grade) since the substance has a greater proportion of high molecular weight constituents (52% of the test substance having a molecular weight of >700 g/mol) that are not likely to pass through biological membranes.