Registration Dossier
Registration Dossier
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EC number: 208-915-9 | CAS number: 546-93-0
Endpoint summary
Administrative data
Description of key information
Magnesium carbonate is not considered to be irritating to the skin or eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
In a reliable GLP in vitro study performed in accordance with EU Method B46, magnesium carbonate was applied to EPISKIN™ reconstituted human epidermis for a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours (Harlan Laboratories Ltd, 2010). A measurement of cytotoxicity in reconstituted human epidermal cultures was made by means of the colourimetric MTT reduction assay. The relative mean viability of the test material treated tissues was 98.3%. Hence, magnesium carbonate is considered to be non-irritating to skin.
In a reliable GLP in vitro skin corrosion study performed in accordance with OECD 431, magnesium carbonate was applied to EPISKIN™ reconstituted human epidermis for a treatment period of 3, 60 or 240 minutes (Harlan Laboratories Ltd, 2010). The relative mean viability of the test material treated tissues was 106.4% after an exposure period of 240 minutes. Magnesium carbonate is therefore not corrosive to the skin.
Eye irritation:
In a reliable GLP in vivo eye irritation study performed in accordance with OECD 405, magnesium carbonate was applied as a single application to the non-irrigated eye of two white rabbits (Harlan Laboratories Ltd, 2010). Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. There were no corneal or iridial effects noted during the study; hence, the mean scores for 24, 48 and 72 hours for each animal were 0. The mean scores for 24, 48 and 72 hours for each animal for conjunctival chemosis and redness, although above 0, were below the limits for classification as irritating to eyes and the effects were fully reversible within an observation period of 72 hours. Magnesium carbonate is therefore non-irritating to eyes.
Justification for classification or non-classification
In the in vitro skin irritation and the in vivo eye irritation studies, magnesium carbonate was non-irritant and therefore requires no classification under either the DSD or CLP.
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