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Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Regarding reproductive toxicity/fertility no study reports for L-serine are available.

A significant amount of L-serine is usually taken up via the food. In usual diet, most amino acids are supplied as constituents of protein and not as free amino acid. Food consumption data indicate that 7.2 g L-serine is consumed daily with a daily intake of 100 g protein. Protein intake clearly modifies plasma amino acid levels. However, amino acid concentrations are subject to homeostasis and the plasma concentrations vary within fixed limits and are tightly regulated.

Exposure with L-serine from uses which are covered by this registration would only marginally increase the total daily L-serine dose which is taken up via the food. Even if the plasma amino acid concentration would increase/vary by any use such fluctuations are physiological and subject to homeostasis. Therefore it is highly unlikely that L-serine taken up via any use covered by this registration would result in systemic effects.

Several repeated dose toxicity studies consistently indicate the very low toxicity of L-serine. Even in very high doses no toxicity is observed and no adverse effects were reported for the reproductive organs.


Short description of key information:
No evidence for effects on fertility.

Effects on developmental toxicity

Description of key information
No evidence for developmental toxicity.
Additional information

Regarding developmental toxicity/teratogenicity no study reports for L-serine are available.

A significant amount of L-serine is usually taken up via the food. In usual diet, most amino acids are supplied as constituents of protein and not as free amino acid. Food consumption data indicate that 7.2 g L-serine is consumed daily with a daily intake of 100 g protein. Protein intake clearly modifies plasma amino acid levels. However, amino acid concentrations are subject to homeostasis and the plasma concentrations vary within fixed limits and are tightly regulated.

Exposure with L-serine from uses which are covered by this registration would only marginally increase the total daily L-serine dose which is taken up via the food. Even if the plasma amino acid concentration would increase/vary by any use such fluctuations are physiological and subject to homeostasis. Therefore it is highly unlikely that L-serine taken up via any use covered by this registration would result in systemic effects.

Justification for classification or non-classification

Additional information