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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

In a reliable GLP study, the test item caused mortalities in the range of 20 to 95% tested with the solid content concentrations of 6.28 -50.2 mg/L. The 96h-LC50 was 26.6 mg/L (expressed as solid content of the test item, nominal) and the 96h-LC0 was < 6.28 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
26.6 mg/L

Additional information

The acute toxicity of the test item Dermalcare MAP L-213/S on embryonic stages of zebrafish (Danio rerio) was determined according to OECD guideline 236 and in compliance with GLP.

The 96–hour acute toxicity was studied under semi-static conditions (with daily renewal of test medium) with the nominal concentrations of 12.5 – 25.0 – 50.0 – 100 – 200 mg/L (corresponding to the solid content concentrations of Dermalcare MAP L-213/S: 3.14 – 6.28 – 12.6 – 25.1 – 50.2 mg/L).

Fish eggs were exposed to each concentration level of test item and to the reference item 3.4-dichloroaniline (at 4 mg/L). In parallel, a control plate and internal controls in each tested plate were used. Mortality was determined observing every days the following biological parameters: coagulation of embryos, absence of somite formation, non-detachment of the tail and lack of heart-beat.

The 96h-LC50 was 26.6 mg/L (expressed as solid content of the test item, nominal) and the 96h-LC0 was < 6.28 mg/L. In the plate of the lowest tested concentration (12.5 mg/L), 2 dead embryos were observed on the internal control. Thus the plate had to be rejected and its results were not included in the evaluation. Moreover, the water parameters were within the acceptable limits and the validity criteria of the guideline were fulfilled.

Based on the results of this study, Dermalcare MAP L-213/S is considered as harmful to fish.

This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater fish.