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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

One reliable study performed under semi-static conditions according to international standard guideline and in compliance with GLP has shown that Mackam LSB-50 has no adverse effects in a limit test on the freshwater species Danio rerio. A 96-h LC50 was determined > 28.1 mg/L (corresponding to a LC50 > 10 mg/L in active ingredient).
Two other limit test were performed on a saltwater species, Turbot (Scophthalmus maximus) according to recommendations of OSPARCOM. Both studies are considered as reliable with restrictions and the lowest 96h-LC50 value was found to be 96h-LC50 > 1.69 mg/L (nominal), which corresponds to a 96h-LC50 > 0.51 mg/L in active ingredient.

Key value for chemical safety assessment

LC50 for freshwater fish:
10 mg/L

Additional information

Three aquatic toxicity tests have been performed on Mackam LSB-50, aqueous solution of the registered substance in water which exhibits an active content of ca. 35.6%. The observed toxicity effects in these tests are expected to be the result of the exposure of aquatic organisms to active content.

The substance is studied under OSPAR Convention and thus two studied were performed on saltwater fish while the third study was performed on a standardized freshwater species regarding REACH. Following OSPARCOM and REACH recommendations, the acute toxicity of the substance was studied in limit tests, as data were already available on other trophic levels (aquatic invertebrates and aquatic plants).

One study on short-term toxicity to freshwater fish was performed under semi-static conditions according to the OECD test guideline 203 and in compliance with GLP. Following the threshold approach recommended by REACH, a limit test was performed on Zebra fish (Danio rerio) at the nominal concentration of 28.1 mg/L (10 mg/L Lauramidopropylhydroxysultaine). The test item had no acute toxic effects on zebra fish up to nominal concentration 28.1 mg/L and thus LC50 value is considered as > 28.1 mg/L (corresponding to LC50 > 10 mg/L in active ingredient).

The 96h-NOEC is also considered > 28.1 mg/L (corresponding to LC50 > 10 mg/L in active ingredient). All the validity criteria are fulfilled and the study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater fish.

Two other limit tests were performed on Turbot (Scophthalmus maximus), a marine species, in a 96-hour semi-static test according the OSPARCOM guidelines. Both test are considered as reliable with restrictions and shown that Mackam LSB-50 has no adverse effects up to concentration of 1.69 mg/L (corresponding to a LC50 > 0.51 mg/L in active ingredient) (Opus, 2009) and 10 mg/L (corresponding to a LC50 > 3 mg/L in active ingredient) (Chemex, 2009).

Based on the results of these studies on freshwater and saltwater fish, Mackam LSB-50 is considered as not toxic to fish in accordance with the EU criterion.