Registration Dossier

Diss Factsheets

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

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 this grade and also the read across substance Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled are negative. Furthermore, neoplastic lesions or hyperplasia have not been identified in a 90-day repeated-dose study, and a carcinogenicity study is not required.


 



Detailed information on the Mode of Action is available in Chapter 3, Annex: Mode of action / Human relevance Framework [124]

Additional information

A carcinogenicity study has not been proposed for Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade) because it does not have a widespread dispersive use nor is there evidence of frequent long-term human exposure.  Furthermore, the substance is not classified as mutagen category 3 nor is there evidence from a 90-day repeated dose toxicity study that the substance is able to induce hyperplasia and/or neoplastic lesions.