Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-562-9 | CAS number: 63-68-3
Endpoint summary
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
Additional information
All of the data for L-methionine regarding toxicity to reproduction is from the public domain, summarizing the findings from experiments conducted with a scientific background rather than gearing to registration requirements. Therefore, the studies employed are not in compliance with standard methods and only partially cover endpoints which are analyzed in up-to-date OECD guideline studies.
However, conventional toxicology studies are considered to be inappropriate for testing essential dietary nutrients like L-methionine. In the case of such substances, there is a physiological concentration that is optimum for health and performance. Dietary intakes of such substances in quantities that lead to body levels significantly below or above optimum levels will cause a physiological imbalance and consequent adverse effects. Toxic levels of supplemented methionine depend on the basal diet and its content of sulphur-containing amino acids. The dietary requirement for methionine plus cysteine (humans) will be the obligatory oxidative losses (methionine plus cysteine), i.e. 10.4 mg/kg per day methionine and 4.1 mg/kg per day cysteine =14.5 mg/kg per day total sulfur amino acids rounded to 15 mg/kg per day (FAO 2002). Exposure with L-methionine from uses which are covered by this registration would only marginally increase the total daily L-methionine 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-methionine taken up via any use covered by this registration would result in systemic/reprotoxic effects.
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
Additional information
All of the data for L-methionine regarding toxicity to reproduction is from the public domain, summarizing the findings from experiments conducted with a scientific background rather than gearing to registration requirements. Therefore, the studies employed are not in compliance with standard methods and only partially cover endpoints which are analyzed in up-to-date OECD guideline studies.
However, conventional toxicology studies are considered to be inappropriate for testing essential dietary nutrients like L-methionine. In the case of such substances, there is a physiological concentration that is optimum for health and performance. Dietary intakes of such substances in quantities that lead to body levels significantly below or above optimum levels will cause a physiological imbalance and consequent adverse effects. Toxic levels of supplemented methionine depend on the basal diet and its content of sulphur-containing amino acids. The dietary requirement for methionine plus cysteine (humans) will be the obligatory oxidative losses (methionine plus cysteine), i.e. 10.4 mg/kg per day methionine and 4.1 mg/kg per day cysteine =14.5 mg/kg per day total sulfur amino acids rounded to 15 mg/kg per day (FAO 2002). Exposure with L-methionine from uses which are covered by this registration would only marginally increase the total daily L-methionine 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-methionine taken up via any use covered by this registration would result in systemic/reprotoxic effects.
There is sufficient data available to permit a conclusion on reproductive and developmental toxicity potential of L-methionine. 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..."
Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
