Registration Dossier

Categories

Categories

Category name:
Cashew Nutshell Extract Category

Justifications and discussions

Category rationale:
In 2010 the single substance Cashew Nutshell Liquid (CAS Number 8007-24-7, EC Number 232-355-4) was registered under REACH which comprised three production forms, namely:
• Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) - EC List Number: 700-991-6
• Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated (Technical Grade) - EC List Number: 941-216-3
• Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade) - EC List Number: 941-212-1
At that time the majority of the data used to address the dossier requirements for the Annex VII and VIII endpoints related to Distilled grade. Subsequently in 2014, based on ECHA Final Decision CCH-D-0000002068-76-06/F, the original dossier was split into separate registrations for the three grades of Cashew Nutshell Extract and the CNSL Consortium has been engaged in a programme of testing to address identified data gaps for physico-chemical, environmental fate and certain mammalian toxicity endpoints for Technical and Distillation Residue grades.
The Consortium recognised that in line with Section 1.5 Annex XI of the REACH Regulation “General rules for adaptation of the standard testing regime set out in Annexes VII to X, any vertebrate testing should be carefully reviewed to ensure that it is proportionate and is only being undertaken as a last resort once other data gathering approaches have been fully explored. This avoids the need to test every substance for every endpoint”. As a result the Consortium have been developing and implementing a category (or grouping) approach and read-across strategy for the three grades to restrict vertebrate testing to an appropriate minimum. Recent discussions with ECHA and comments from the Member States have resulted in the current proposed approach whereby the data for Technical grade for certain Annex VII to X endpoints will be read-across by interpolation from information on Distilled and Distillation Residue grades. In this context interpolation is “the estimation of a value for a member of the group using measured values from other members on both sides of that member within the defined group spectrum”. The use of data from two source substances (Distilled and Distillation Residue grades) to read-across to Technical grade is considered to provide greater confidence in the predicted data for the target substance.
Applicability domain
The category is applicable to the three grades of processed cashew nutshell extract, namely Distilled, Technical and Distillation Residue (or Distilled Residue) grades considering physico-chemical, toxicological, ecotoxicological and environmental fate properties.

Further information on the category justification, including Evidence for the grouping of the three grades into a category and Evidence for the proposed read-across approach using interpolation can be found in the appended document.