Registration Dossier
Registration Dossier
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EC number: 248-375-1 | CAS number: 27253-33-4
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 calcium neodecanoate are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties calcium and neodecanoate.
Calcium neodecanoate is not expected to impair fertility, since the two moieties calcium and neodecanoate have not shown adverse effects on fertility. No information on the developmental toxicity of the moieties calcium and neodecanoic acid is available.
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
Calcium
Calcium plays an essential role in male and female fertility. It is involved in normal spermatogenesis, sperm maturation and sperm motility as well as in maintaining optimal conditions for acrosome reaction, which is necessary for the fertilization process. All these processes indicate the pivotal role of calcium in human fertility in men and women. It is therefore concluded that calcium itself does not show any effects on the impairment of male or female fertility. Additional studies in animals are not believed to contribute to the existing evidence for a lack of reproductive toxicity of calcium. Thus, further studies in animals are considered to be scientifically unjustified.
Neodecanoate
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.
No classification for reproductive or developmental toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.
Calcium neodecanoate
Calcium neodecanoate is not expected to show effects on reproduction, since the two moieties calcium and neodecanoic acid have not shown toxicity to the reproduction in a range of test systems. Thus, calcium neodecanoate is not to be classified according to regulation (EC) 1272/2008 for reproductive toxicity. Further testing is not required. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR.
Information on the individual constituents calcium and neodecanoic acid will be used for the hazard assessment and, when applicable, for the risk characterisation of calcium neodecanoate. For the purpose of hazard assessment of calcium neodecanoate, the point of departure for the most sensitive endpoint of each constituent will be used for the DNEL derivation. In case of neodecanoic acid in calcium neodecanoate, the NOAEL of 75 mg/kg bw/day for the reproductive toxicity will be used.
Effects on developmental toxicity
Description of key information
No toxicity data on adverse effects on sexual function and fertility with calcium neodecanoate are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties calcium and neodecanoic acid.
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
Justification for classification or non-classification
Calcium neodecanoate is not expected to impair fertility, since the two moieties calcium and neodecanoate have not shown adverse effects on fertility. No information on the developmental toxicity of the moieties calcium and neodecanoic acid is available, thus no final conclusion on classification and labelling can be made.
Additional information
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