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Key value for chemical safety assessment

Additional information

A document which justifies the read–across from Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (“Distilled Grade”) and Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distillation Residue ("Distillation Residue Grade") to Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated (“Technical Grade”) is attached.


Short description of key information:
In a reverse gene mutation assay in bacteria, strains TA98, TA100, TA1535 and TA 1537 of S. typhimurium were exposed to Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade), at concentrations of 0, 50, 150, 500, 1500 and 5000 µg/plate in the presence and absence of mammalian metabolic activation.
The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background for the test substance.

This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.

In a mammalian cell cytogenetics assay [chromosome aberration], human cell cultures were exposed to Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) at concentrations of 0, 1.56, 3.125, 6.25, 25 and 50 µg/ml without S9 metabolic activation and 0, 0.78, 1.56, 3.125, 6.25, 12.5 and 25 with S9 metabolic activation.
Positive controls induced the appropriate response. There was no evidence of chromosome aberrations induced over background with the test substance.

This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 473 for in vitro cytogenetic mutagenicity data.

In a mammalian cell gene mutation assay [HGPRT], Chinese hamster ovary cell cultures were exposed to cashew nutshell liquid at concentrations of 0, 0.75, 1.5, 3, 6 and 12 µg/ml without S9 metabolic activation and 0, 1.5, 3, 6, 12 and 18 with S9 metabolic activation.
Positive controls induced the appropriate response. There was no evidence of mutations induced over background with the test substance.

This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 476 for in vitro mammalian gene cell mutagenicity data.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Negative results have been obtained inin vitrogene mutation, mammalian cell cytogenetic assay (chromosome abberation) and a mammalian cell gene mutation assay, therefore, Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is not considered to be genotoxicin vitro. A similar conclusion is expected for Cashew Nutshell Extract, Decarboxylated (Technical Grade) based on the read-across justification.