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Additional information

Negative results have been obtained in in vitro gene mutation, mammalian cell cytogenetic assay (chromosome abberation) and a mammalian cell gene mutation assay on the read-across substance Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade), which is not considered to be genotoxic in vitro. A similar conclusion is expected for Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade) based on the read-across justification. 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 (Distillation Residue Grade) is attached.


 


   


 Short description of key information:   


 


In a Bacterial Reverse Mutation Assay in bacteria strains TA98, TA100, TA1535 and TA 1537 of S. typhimurium and E.coli WP2 uvr A pKM 101 were exposed to Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade), at concentrations of 0, 5, 15, 50, 150, 500, 1500, 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 Bacterial Reverse 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)


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


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Justification for classification or non-classification

Negative responses have been obtained in an OECD TG471 Bacterial Reverse Mutation Assay (In vitro gene mutation study in bacteria) using Distillation Residue Grade. The study used test concentrations of  5, 15, 50, 150, 500, 1500, 5000 µg/plate with S. typhimurium TA98, TA100, TA1535 and TA 1537 bacteria (both with and without metabolic. activation) and also E. coli WP2 uvr A pKM 101 bacteria (with and without metabolic activation). The positive controls induced the appropriate responses in the strains tested.

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