Registration Dossier

Administrative data

Description of key information

Information from the repeat dose and reproductive toxicity screening test on Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) demonstrate low sub-acute oral toxicity and can be used to infer low acute toxicity. In the combined repeated dose/reproductive toxicity screening test, serious adverse effects are not observed with oral dietary doses of up to 1000 mg/kg bw/day, following dosing for 54 consecutive days. On this basis it was not considered appropriate to test for acute oral toxicity, as absence of severe adverse effects at this dose following repeated dosing indicates that mortality is unlikely to occur after a single dose in an acute oral toxicity test at doses that would trigger classification. 
A limit dose test of 2000 mg/kg bw/day can be waived, as no further information on hazard class would be generated. Limit tests are usually required by regulatory regimes when a substance is not expected to be toxic. However, REACH allows for waiving of tests where the hazard and risk of a substance can be inferred by alternative means. Expert judgement can, therefore, be exercised to waive the acute oral toxicity test, based on a weight of evidence approach.
 
In an acute dermal toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single dermal dose of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) at 2000 mg/kg bw and observed for 14 days. Deaths did not occur in this study, therefore, it can be determined that Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is of low acute dermal toxicity. Severe skin reactions were observed in all animals at the test substance application site.
 
Exposure of humans to Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) via inhalation is not likely, taking into account the vapour pressure of the substance and the low possibility of exposure to aerosols, particles or droplets of an inhalable size.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

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.

Justification for classification or non-classification

An LD50 of >2000 mg/kg bw was idenitified from an acute dermal toxicity study, therefore Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) is of low acute dermal toxicity and does not warrant classification under the DSD. However, classification with category 4, harmful in contact with skin, is appropriate under CLP.

Information from a sub-acute repeat dose toxicity combined screening test infers that effects do not occur at doses up to 1000 mg/kg bw/day, therefore, classification with category 4, harmful in contact with skin, is appropriate under CLP.

No data are available to classify the acute inhalation effects.

A similar conclusion is expected for Cashew Nutshell Extract , Decarboxylated (Technical grade) based on the read-across justification.