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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
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 effects of lactic acid and calcium chloride.

The contact dermal sensitization potential of the test article, SY-83 (lactic acid), was investigated using a modified Buehler Closed Patch Test. No mortalities occurred and all animals gained body weight. The test article (100%) produced very slight erythema at 3 sites and very slight edema at l site after the Ist induction. Erythema grades increased in severity after the 2nd induction application. One site was graded as severe erythema, however, this grade was given a 4 due to pinpoint pitting of the skin and scab formation, not for redness. Due to the increase of severity of the reactions, the concentration of the test article for induction was reduced to 30% and the induction site was changed to the left flank. Very slight erythema was noted after the 5th induction application. Grades ranging from very slight to severe erythema were noted from the 7th to the 9th induction applications. Again, the severe (grade 4) reactions were given this grade due to pinpoint pitting of the skin and the eschar formation, not for redness.

After the challenge application, the test article (100%) produced grade 4 erythema in up to 6 test animals. These gradings were very similar in character as those seen during the induction applications, that is, pinpoint pitting of the skin and eschar formation, very little redness. These reactions were considered to be irritation reactions, not sensitization reactions. Other reactions noted at challenge for the test animals were very slight to moderate erythema, and very slight to moderate edema. The test article (100%) produced grade 4 erythema in up to 8 naive control animals. These gradings were also pinpoint pitting of skin and eschar formation with very little redness. These reactions were considered to be irritation reactions, not sensitization reactions. Other reactions noted for the naive control animals were very slight to moderate erythema and very slight to moderate edema. The reactions seen in the naive control animals at the challenge application were similar to the reactions seen for the test group animals and the test article, SY-83, was not considered to be a contact dermal sensitizer.

Calcium chloride is considered not to have any sensitising properties, based on the physiological role of both its constituent ions, as well as the fact that sensitising effects of both ions have never been reported, despite long-term historical and wide dispersive use (e.g. via food and medication).


Migrated from Short description of key information:
Calcium lactate fully dissociates into Ca2+ ions and lactate. The toxicological effects of calcium lactate can be understood in terms of the toxicological effects of lactic acid and calcium chloride (see read across document). Calcium lactate shall not be considered as sensitising to the skin.

Justification for selection of skin sensitisation endpoint:
Weight of evidence approach based on information for calcium chloride and lactic acid.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Since calcium lactate fully dissociates into Ca2+ ions and lactate, the sensitization potential of the substance was assessed based on the sensitisation potential of calcium chloride and lactic acid. None of the two has sensitising properties and hence, no classification is required for calcium lactate.

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