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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-742-8 | CAS number: 57453-97-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No toxicity data on adverse effects on sexual function and fertility with magnesium neodecanoate are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties magnesium and neodecanoic acid.
Magnesium neodecanoate is not expected to impair sexual function or fertility, since the two moieties magnesium and neodecanoate have not shown respective adverse effects.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No toxicity data on adverse effects on sexual function and fertility with magnesium neodecanoate are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties magnesium and neodecanoic acid.
Magnesium
Magnesium is of great importance in human fertility and development. The scientific evidence was taken into account by the Scientific Committee on Food which concluded that magnesium lacks effects on the reproductive function in humans. Also, magnesium is necessary for DNA replication and bone development during pregnancy, demonstrating the pivotal role of magnesium in human fertility in man and women. It is therefore concluded that magnesium itself does not show any developmental toxicity effects. Additional studies in animals are not believed to contribute to the existing evidence for a lack developmental toxicity of magnesium.
Neodecanoic acid
In a modified three-generation reproductive toxicity study, male and female Sprague-Dawley rats were administered neodecanoic acid at 0, 100, 500 and 1500 ppm (approximately 0, 5, 25 and 75 mg/kg-bw/day, respectively) in the diet. No adverse effects were observed on survival, appearance, behaviour, body-weight gain and food consumption in the parental, F1 or F2 generations. The reproductive performance of the parents was not affected. No treatment-related gross or microscopic pathological findings were observed at any of the dietary levels.
Magnesium neodecanoate
As the two moieties of magnesium neodecanoate do not impair sexual function, fertility or the development of the offspring, magnesium neodecanoate in all probability does also not have reproductive toxic effects.
Information on the individual moieties magnesium and neodecanoic acid will be used for the hazard assessment and, when applicable, for the risk characterisation of magnesium neodecanoate.
Effects on developmental toxicity
Description of key information
No toxicity data on adverse effects on sexual function and fertility with magnesium neodecanoate are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties magnesium and neodecanoic acid.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
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
Magnesium:
According to the overall conclusion on the role of magnesium for human development, magnesium is considered not to impair the development of the offspring, but in contrary is recognised as essential for all aspects of an unimpeded normal reproduction.
Neodecanoate:
In a three generation reproductive toxicity study according to OECD guideline 416 with neodecanoic acid administered in the diet up to and including a dose level of 1500 ppm, the F1 and F2 offspring was free of adverse effects.
Magnesium neodecanoate:
Magnesium neodecanoate is not expected to have adverse effects to the developing embryo or fetus requiring classification, since there are no indications that the two moieties magnesium and neodecanoate have such effects.
Justification for classification or non-classification
As there are no indications that the two moieties of magnesium neodecanoate impair sexual function, fertility or the development of the offspring, magensium neodecanoate in all probability does also not have reproductive toxic effects.
According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, magnesium neodecanoate does not have to be classified and has no obligatory labelling requirement for reproductive toxicity.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.
