Registration Dossier
Registration Dossier
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EC number: 248-953-3 | CAS number: 28305-25-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Calcium lactate fully dissociates into Ca2+ ions and lactate- under aqueous and/or physiological conditions.The toxicological effects
of calcium lactate can be understood in terms of the toxicological effect of calcium ions and lactic acid (see read-across statement).
Lactic acid is a major and essential species in mammalian primary metabolism, and a ubiquitous ingredient in all kinds of food. Reproduction toxicity is not a relevant endpoint for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.
Calcium ions will usually not reach the foetus or the male and female reproductive organs when exposed orally, dermally or by inhalation, as they are strictly regulated; hence, in accordance with section 1 of REACH Annex XI, testing does not appear scientifically necessary and a reproduction toxicity study was not performed.
Based on the above information calcium lactate shall not be considered to be a reproductive toxicant.
Short description of key information:
See below.
Effects on developmental toxicity
Description of key information
See below.
Additional information
Calcium lactate fully dissociates into Ca2+ ions and lactate. The toxicological effects of calcium lactate can be understood in terms of the toxicological effect of calcium chloride and lactic acid (see read-across statement).
Lactic acid is a major and essential species in mammalian primary metabolism, and a ubiquitous ingredient in all kinds of food. Developmental toxicity is not a relevant endpoint for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.
Calcium chloride will neither reach the foetus nor the female reproductive organs ( as it does not become systemically available), which shows that there is no risk for developmental toxicity. Even so, an oral developmental study in 3 species (mouse, rat and rabbit) is available. In all three species no maternal or teratogenic effects were noted, and NOAEL 's were above highest dose given. It is confirmed that there is no concern with regard to developmental toxicity (at least up to 169 mg/kg/d for rabbits), which supports the general consideration that the substance will usually not reach the foetus.
Based on the above information calcium lactate shall not be considered to be a developmental toxicant.
Justification for classification or non-classification
Based on the above provided information, classification of calcium lactate for reproduction or developmental toxicity is not warranted in accordance with Directive 67/548/EEC and EU (CLP) Regulation (EC) No. 1272/2008.
Additional information
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