Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Calcium carbonate magnesium oxide is considered to be irritating to skin and the respiratory system and to entail a risk of serious damage to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The results of an available in vivo skin irritation study (rabbit) on calcium hydroxide indicate by read-across that calcined dolomite may be irritating to skin (pH effect).

In the available eye irritation studies (in vivo, rabbit), both CaO and Ca(OH)2 caused irreversible lesions in the eye. By read-across these results are also applicable for calcined dolomite, applying a worst case approach.

From human data on calcium oxide and hydroxide it is concluded by read-across (worst case approach) that calcined dolomite is irritating to the respiratory tract.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Based on experimental results for a similar substance utilised by read-across, calcined dolomite requires classification as irritating to skin [R38, irritating to skin; Skin Irrit 2 (H315 – Causes skin irritation)].

Based on experimental results for a similar substance utilised by read-across, calcined dolomite requires classification as severely irritating to the eye [R41, Risk of serious damage to eye; Eye Damage 1 (H318 - Causes serious eye damage)].

Based on human data as summarised and evaluated in the SCOEL recommendation for CaO and Ca(OH)2 (Anonymous, 2008; see section 7.2.2 of the technical dossier), it is proposed to classify calcined dolomite as irritating to the respiratory system [R37, Irritating to respiratory system; STOT SE 3 (H335 - May cause respiratory irritation)].