Registration Dossier

Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Calcium and chloride are essential nutrients for the physiology and homeostasis of humans. Calcium and chloride are both naturally present in food in significant quantities. For calcium the average requirement (AR) for adults ≥ 25 years was reported to be 750 mg/day (EFSA, 2015). The dietary reference value for chloride is 3.1 g/day for adults including pregnant and lactating women (EFSA, 2019b). In addition, it was reported that the use of calcium chloride as food additive (E 509) does not raise a safety concern at the reported use and use levels EFSA (2019a). It is therefore considered that additional reproductive toxicity testing on calcium chloride is not necessary.

Effects on developmental toxicity

Description of key information

An oral developmental study was performed in 3 species (mouse, rat and rabbit). In all three species no maternal or teratogenic effects were noted, and NOAELs were above the highest dose given.

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
169 mg/kg bw/day
Additional information

It can be stated that the substance will neither reach the foetus nor reach male and female reproductive organs ( as it does not become systemically available), which shows that there is no risk for developmental toxicity and no risk for toxicity to reproduction.

It is confirmed in three species 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. As such, it is considered not useful to perform a reproduction study.

Justification for classification or non-classification

Based on the results of the available developmental toxicity studies with three different species, and taking into account normal physiological roles of calcium and chloride ions, classification of calcium chloride for reproductive and developmental toxicity is not warranted in accordance with the EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.