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Long-term toxicity to fish

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Description of key information

In accordance with column 2 of REACH annex IX, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.

Key value for chemical safety assessment

Additional information

In acute toxicity tests using aquatic organisms of 3 trophic levels, fish proved somewhat more sensitive than other organisms. However:

-        the lowest fish 96h LC50 value (0.32 mg/l) was not greatly different to the Daphnia 48h EC50 value (1.65 mg/l).

-        Comparison of the 48h EC50 and 21-day NOEC in Daphnia tests does not support any marked increase in toxicity following prolonged exposure.

-        Long-term test data are available for two trophic levels (invertebrates and algae).

Hence a reliable value for PNEC (aquatic organisms) was calculated following R.10 guidance: this compared the value calculated from the lowest long-term aquatic NOEC with that calculated from the fish acute test data and took the lower PNEC value. In this way, the risk to aquatic organisms was adequately assessed. For these reasons, and in accordance with REACH Annex IX column 2, no long-term fish testing is necessary.