Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

long-term toxicity to aquatic invertebrates
Data waiving:
other justification
Justification for data waiving:

Data source

Materials and methods

Test guideline
according to
OECD Guideline 211 (Daphnia magna Reproduction Test)
Principles of method if other than guideline:
The current ecotoxicological dataset for Cashew Nutshell Extract, Decarboxylated, (Technical Grade) contains experimental short-term information for freshwater algae, invertebrates and fish. This short-term data can be considered robust (Klimisch Code 2) because the studies used internationally recognised test guidelines which were carried out to Good Laboratory Practice (GLP). The short- term toxicity tests were carried out using water accommodated fractions (WAFs) and showed that there was no acute toxicity at the water solubility limit (0.3 mg/l).

In order to refine the PNECwater values and confirm the Toxicity (T) element of the PBT assessment it is initially proposed to conduct a long-term Daphnia magna reproduction study using the read across substance Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade). This test is proposed rather than a long-term fish toxicity test to avoid unnecessary animal testing.

The test would be carried out according to OECD Test Guideline 211”Daphnia magna reproduction test” and to GLP. The study will assess the effect of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) on the reproductive output of the invertebrate Daphnia magna Straus. To this end, young female Daphnia will be exposed to the test substance added to water at a range of concentrations (at least five). For flow-through tests, 40 animals divided into four groups of 10 animals at each test concentration, will be used. The test duration will be 21 days. Reproductive output of the parent animals and the total number of living offspring produced per parent alive at the end of the test will be reported. The study report will also include: the daily counting of the offspring, the daily recording of the parent mortality, the weekly measurement of oxygen concentration, temperature, hardness and pH values and the determination of the concentrations of test substance.

The results of this test will be relevant for Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distilled Residue Grade). For justification of read-across, please refer to the document "Rationale for the grouping and read-across approach for the three grades of processed Cashew Nutshell Extract" located in Section 13.

Test material

Details on test material:
- Name of test material (as cited in test report): Cashew Nutshell Extract, Decarboxylated, Distillation Residue (Distillation Residue Grade)
- Physical state: liquid
- Other: Straw coloured to dark brown liquid

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
Water media type:

Results and discussion

Applicant's summary and conclusion