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Long-term toxicity to fish

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Description of key information

No long-term toxicity data are available for the toxicity of calcium lactate to fish. However, a waiver is applied for this endpoint.

Key value for chemical safety assessment

Additional information

Calcium lactate fully dissociates into Ca2+ ions and lactate. The ecotoxicology of calcium lactate can be understood in terms of the ecotoxicology of calcium chloride and lactic acid.

Calcium chloride is not toxic in short-term toxicity tests with fish at concentrations far above 100 mg/L, the limit concentration, showing that Ca2+ is not toxic to aquatic organisms. Lactic acid shows slight effects at 56 mg/L in a short-term toxicity test with rainbow trout, while the LC50 was 130 mg/L. However, it should be noted that all observed effects are due to the low pH induced by high concentrations of lactic acid, and will completely disappear at lower concentrations. This is also evident from available aquatic toxicity studies to Daphnia with sodium lactate, which has a LC50 of > 6 g/L (>53.5 mM) and (acute) NOEC of 6 g/L (compare with acute daphnia LC50 for lactic acid is 130 mg/L (1.44 mM)). When comparing toxicity expressed in molar concentrations, toxicity to Daphnia was >37 times lower for sodium lactate compared to lactic acid (>53.5/1.44 = >37). Therefore toxicity of lactate, be it in the form of sodium lactate or calcium lactate, to fish is expected to be much lower than for lactic acid as well. Moreover, relevant chronic toxicity is not expected from a substance that is an essential part of primary biochemical processes.

Testing is waived since it is shown highly unlikely that adverse effects of calcium lactate occur in short-term toxicity test with fish at concentration up to 100 mg/L, the limit concentration. Further, calcium lactate is readily biodegradable (see section 5.2.1) and as a consequence, no chronic exposure of fish is expected.

Therefore, and for reasons of animal welfare, a long-term toxicity study in fish is not provided.

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