Registration Dossier
Registration Dossier
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EC number: 941-216-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Information from the OECD 422 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. The OECD TG408 Repeated Dose 90-day Toxicity study on Distilled Grade and the OECD TG408 Repeated Dose 90-day Toxicity study on Distillation Residue Grade both demonstrate low sub-acute oral toxicity and can be used to infer low acute toxicity. Therefore, by interpolation, low data on the acute oral toxicity of the target substance Technical Grade has been estimated from the data on the source substances. 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. A similar result of low acute dermal toxicity is expected for Technical Grade
Exposure of humans to Cashew Nutshell Extract, Decarboxylated (Technical 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
- Value:
- 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 identified from an acute dermal toxicity study, therefore for Cashew Nutshell Extract, Decarboxylated (Technical Grade) 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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