Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Lactic acid is not only a natural molecule found in all higher animals and many microorganisms but also a ubiquitous ingredient used in various kinds of food. Therefore, it is not possible to lower external exposure levels below the minimum required levels for human physiological functions. Nevertheless, given the understanding of lactic acid production under human physiological conditions, there is no reproductive/developmental toxicity concern of lactic acid.

Lactic acid is an natural metabolite found in humans and animals as it can be endogenously produced from metabolic pathways such as glycogen breakdown, glycolysis and amino acid metabolism. Normal human blood contains 8-17 mg lactic acid/100 mL plasma, and the concentration of lactate in normal human skin is three times or more of that in the blood due to glycolytic enzymes, which actively convert glucose to lactic acid in the epidermis. Furthermore, lactic acid bacteria, which produce lactic acid as one of their major fermented products, are abundantly found in humans, including breast milk and vaginal cavity, and are considered as probiotic bacteria. Infants can be exposed to lactic acid bacteria during breastfeeding. Lactic acid bacteria are known to be beneficial in preserving healthy vaginal functions such as maintenance of acidic vaginal pH and the prevention of infections.

The lack of reproductive/developmental toxicity concern of lactic acid is also supported by animal data on foetal development or sex ratio (see IUCLID sections 7.8.1 and 7.8.2).

In accordance with Section 1 of REACH Annex XI, reproductive/developmental toxicity study does not need to be conducted. Given the existing data and taking a weight-of-evidence approach, there is no reproductive/developmental toxicity concern of lactic acid.

Link to relevant study records
Reference
Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information
Reproductive effects observed:
not specified

Effects on developmental toxicity

Description of key information

Lactic acid is not only a natural molecule found in all higher animals and many microorganisms but also a ubiquitous ingredient used in various kinds of food. Therefore, it is not possible to lower external exposure levels below the minimum required levels for human physiological functions. Nevertheless, given the understanding of lactic acid production under human physiological conditions, there is no reproductive/developmental toxicity concern of lactic acid.

Lactic acid is an natural metabolite found in humans and animals as it can be endogenously produced from metabolic pathways such as glycogen breakdown, glycolysis and amino acid metabolism. Normal human blood contains 8-17 mg lactic acid/100 mL plasma, and the concentration of lactate in normal human skin is three times or more of that in the blood due to glycolytic enzymes, which actively convert glucose to lactic acid in the epidermis. Furthermore, lactic acid bacteria, which produce lactic acid as one of their major fermented products, are abundantly found in humans, including breast milk and vaginal cavity, and are considered as probiotic bacteria. Infants can be exposed lactic acid bacteria during breastfeeding. Lactic acid bacteria are known to be beneficial in preserving healthy vaginal functions such as maintenance of acidic vaginal pH and the prevention of infections.

Lastly, existing animal data provide some evidence that there is no lactic acid-specific effect on foetal development or sex ratio.

In accordance with Section 1 of REACH Annex XI, reproductive/developmental toxicity study does not need to be conducted. Given the existing data and taking a weight-of-evidence approach, there is no reproductive/developmental toxicity concern of lactic acid.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information
Species:
rat
Abnormalities:
not specified
Developmental effects observed:
not specified

Justification for classification or non-classification