DL-alanine

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

DL-alanine and structurally related substances did not show effects on the reproductive organs in repeated dose toxicity studies at tested levels of ~2000 -7000 mg/kg bw/day,

which are higher than the limit testing dose of 1000 mg/kg bw/day, and much higher than the estimated daily intake of ca. 48 mg/kg bw/day. Alanine is an amino acid that is required for normal functioning of humans. Alanine is of low toxicological activity and subject to homeostasis. Therefore, reprotoxic effects are not expected for DL-alanine.

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Regarding reproductive toxicity/fertility no study reports or published papers for DL-alanine are available. A significant amount of DL-alanine is usually taken up via the food. In standard diet, most amino acids are supplied as constituents of protein and not as free amino acid. 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 to DL-alanine from uses which are covered by this registration would only marginally increase the total daily DL-alanine 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 DL-alanine taken up via any use covered by this registration would result in systemic effects. A 26 -wk repeated dose toxicity study indicates the very low toxicity of DL-alanine. Even in very high doses no toxicity is observed and no adverse effects were reported for the reproductive organs.

There is sufficient weight of evidence for the absence of reprotoxic effects. A screening for reproductive toxicity (REACH Annex VIII No. 8.7.1) as well as any study on reproductive toxicity as REACH Annex IX no. 8.7 are not to be conducted in accordance with REACH Annex XI no. 1.2. and for reasons of animal welfare: "Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available, further testing on vertebrate animals for this property shall be omitted..."

Short description of key information:
Fertility is not expected to be affected by DL-alanine and no test is required for this substance.

Effects on developmental toxicity

Description of key information

DL-alanine and structurally related amino acids did not show effects on the reproductive organs in repeated dose toxicity studies at tested levels of ~2000 -7000 mg/kg bw/day,

which are higher than the limit testing dose of 1000 mg/kg bw/day, and much higher than the estimated daily intake of ca. 48 mg/kg bw/day. Alanine is an amino acid that is required for normal

functioning of humans. Alanine is of low toxicological activity and subject to homeostasis. Therefore, developmental effects are not expected for DL-alanine.

DL-alanine and structurally related substances did not show effects on the reproductive organs in repeated dose toxicity studies at tested levels of ~2000 -7000 mg/kg bw/day,

which are higher than the limit testing dose of 1000 mg/kg bw/day, and much higher than the estimated daily intake of ca. 48 mg/kg bw/day. Alanine is an amino acid that is required for normal functioning of humans. Alanine is of low toxicological activity and subject to homeostasis. Therefore, reprotoxic or developmental effects are not expected for DL-alanine.

DL-alanine and structurally related substances did not show effects on the reproductive organs in repeated dose toxicity studies at tested levels of ~2000 -7000 mg/kg bw/day,

which are higher than the limit testing dose of 1000 mg/kg bw/day, and much higher than the estimated daily intake of ca. 48 mg/kg bw/day. Alanine is an amino acid that is required for normal functioning of humans. Alanine is of low toxicological activity and subject to homeostasis. Therefore, reprotoxic or developmental effects are not expected for DL-alanine.

Additional information

Regarding developmental toxicity no study reports for DL-alanine are available. A significant amount of DL-alanine is usually taken up via the food. In standard diet, most amino acids are supplied as constituents of protein and not as free amino acid. 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 DL-alanine from uses which are covered by this registration would only marginally increase the total daily DL-alanine 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 DL-alanine taken up via any use covered by this registration would result in systemic effects including effects on unborn life.

There is sufficient weight of evidence for the absence of developmental toxicity / teratogenicity. Any study on developmental toxicity / teratogenicity as REACH Annex IX no. 8.7 are not to be conducted in accordance with REACH Annex XI no. 1.2. and for reasons of animal welfare: "Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available, further testing on vertebrate animals for this property shall be omitted..."

Justification for classification or non-classification

There is no indication that DL-alanine causes toxicity to reproduction or is developmental toxic. Thus, classification as to reproductive/developmental toxicity according to EU-GHS is not required.