Registration Dossier

Administrative data

Description of key information

A carcinogenicity study has not been proposed as it may be waived under the specific rules for adaptation to testing.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A carcinogenicity study has not been proposed for Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) because it does not have a widespread dispersive use nor is there evidence of frequent long-term human exposure; and the substance is not classified as mutagen category 3 nor is there evidence from a 28 -day study that the substance is able to induce hyperplasia and/or neoplastic lesions. A similar conclusion is expected for Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distilled Residue Grade) based on the read-across justification.

 

Read across justification - please refer to the document " Rationale for the grouping and read-across approach for the three grades of processed Cashew Nutshell Extract" located in Section 13.

 

Justification for classification or non-classification

Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distilled Residue Grade) will not be classified for carcinogenicity as genotoxicity studies for the read across substance Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled are negative, neoplastic lesions or hyperplasia have not been identified in repeated-dose studies, and a carcinogenicity study is not required.