Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
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.

Migrated from Short description of key information:
In a dermal sensitization study with Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade), guinea pigs (20) were tested with in a guinea pig maximisation test.
Positive reactions in 30% of test animals is required for a positive sensitising result in an adjuvant test. A positive response was elicited in 70% of animals when challenged with a 5% concentration. Therefore, according to guidelines, this substance is a sensitser.

In a dermal sensitization study with distilled CNSL in acetone/olive oil 4:1, four young adult CBA mice were tested using the LLNA method. Mild redness to the eyes and neck were observed in test animals. No other clinical signs of toxicity were noted and mortality did not occur. Bodyweights of treated animals were comparable to that of controls.
Stimulation indexes of 29.29 and 30.90 were identified, for NX-4708 and NX-2023, respectively. In this study, Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is a dermal sensitiser. A similar conclusion is expected for Cashew Nutshell Extract, Decarboxylated (Technical Grade) based on the read-across justification.

Justification for classification or non-classification

In a guinea pig maximisation test, positive response was elicited in 70% of animals when a 1% induction dose was applied, and challenged with a 5% concentration. Therefore, according to guidelines, this substance is a demal sensitser.Greater than 60% of animals responded at a 1% intradermal induction dose, therefore sub-category 1A is appropriate.

In a LLNA, Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) gave stimulation indexes of 29.29 and 30.90 following adminsitration of 10% dose, therefore is classed as a dermal sensitiser. The EC3 value was not directly determined, however, 10% of test substance elicited a stimulation index of 30 (EC3 = % test substance required to elicit a stimulation index of 3).

The two studies indicate that Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is a skin sensitiser category 1A. A similar conclusion is expected for Cashew Nutshell Extract, Decarboxylated (Technical Grade) based on the read-across justification.