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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur

Description of key information

In accordance with column 2 of Annex VIII of the REACH regulation, testing for this end point is considered scientifically unjustified since there are mitigating factors indicating that aquatic toxicity is unlikely to occur as the test substance is highly insoluble in water. And also having experimental partition coefficient value i.e. Log Pow is 5.4148 at 25 °C. Thussubstancecan be considered to be hydrophobic in nature.  

Key value for chemical safety assessment

Additional information

In accordance with column 2 of Annex VIII of the REACH regulation, testing for this end point is considered scientifically unjustified since there are mitigating factors indicating that aquatic toxicity is unlikely to occur as the test substance is highly insoluble in water. And also having experimental partition coefficient value i.e. Log Pow is 5.4148 at 25 °C. Thussubstancecan be considered to be hydrophobic in nature.  

Study 1: Aim of this study was to assess the short term toxicity of test chemical to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs. The stock solution 100 mg/l was prepared by dissolving colourless liquid in reconstituted water. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample with reconstituted test water..0, 6, 10, 17, 29 and 50 mg/l concentrations were used in the study. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 18.7 mg/L on the basis of mobility inhibition effects in a 48 hour study. As the chemical was insoluble in normal water, and in the above study chemical dissolved in the medium so that the solubility increases and the effect were observed. But on the above results chemical does not consider to be classified in the category of toxic chemical.