Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
Systemic effects following repeated dosing indicate that a source substance 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, (Technical 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 a source substance Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is distributed throughout the body, however, the extent of such distribution is unknown. A similar outcome is expected for Cashew Nutshell Extract, Decarboxylated (Technical Grade).
No data are available to conclude on the metabolism of Cashew Nutshell Extract, Decarboxylated (Technical Grade).
No data are available to conclude on the excretion rate, extent and pathways of Cashew Nutshell Extract, Decarboxylated (Technical Grade)
There is no information on the systemic effects, metabolism, distribution and excretion rate of Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade).

Category: Cashew Nutshell Exctract category

Data source

Materials and methods

Test material

Reference
Name:
Unnamed

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
Absorbed via the gastro-intestinal tract (rate and extent of absorption cannot be elucidated from the data available)
Type:
absorption
Results:
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 CNSL

Any other information on results incl. tables

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).

Applicant's summary and conclusion