Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

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

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Description of key information

- no adverse effects on fertility, development or reproduction: published data from animal studies (feeding studies, rats; intravenous for parenteral nutrition, rats and human, gavage, rats, similar to OECD guideline 408)

Additional information

L-Asparagine is a ubiquitous occurring molecule, known to be readily metabolised by the intermediary metabolism. It is a substrate for the synthesis of L-aspartic acid and therefore participates as a precursor in the generation of neurotransmitter, i.e. glutamate and aspartate. Furthermore, once aspartic acid is synthesised, it plays a key role in the urea cycle. The metabolism of L-asparagine is not restricted to mammalian species, also algae and bacteria are capable of using asparagine as a carbon source for energy supply (Oda et al. 1982, Alpert et al. 2009). It was also known that the amino acid requirements for human differ significantly dependent on health status or pregnancy and also life style. It was reported that the concentration of asparagine significantly increased in the coelomic fluid during the first trimester. These findings indicate that the requirements for asparagine are higher in the developing embryo than in maternal serum. In a study conducted with rats which were fed a diet containing up to 800 mg/100g diet asparagine, that a requirement for asparagine during pregnancy is indicated, and its omission from the diet during periods of rapid fetal brain growth may impair neurological development in the fetus. Based on the numerous publications demonstrating no adverse effects by the administration of L-asparagine and due to reasons of animal welfare, a toxicity to reproduction study is scientifically not justified. For a more detailed expalanation please refer to the 'Toxicity to reproduction_statement'.

Justification for classification or non-classification

Based on the available and adequate data the substance does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) with respect to toxicity to reproduction.