Registration Dossier

Administrative data

Description of key information

The substance is considered to be irritating to skin and the respiratory system and entails 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 studies (rabbit) indicate that the substance may be irritating to skin (pH effect), by read-across from Ca(OH)2. In the available eye irritation study (in vivo, rabbit), Ca(OH)2 caused irreversible lesions in the eye. By read across the results are also applicable for “Reaction mass of Limestone and dicalcium silicate”. From human data on calcium oxide and hydroxide it is concluded by read-across (worst case approach) that target substance 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 on a similar substance utilised by read-across, “Reaction mass of Limestone and dicalcium silicate” requires classification as irritating to skin (R38, irritating to skin; Skin Irrit 2 (H315 – Causes skin irritation)) and 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 (Anonymous, 2008: Recommendation from the Scientific Committee on Occupational Exposure Limits for Calcium oxide (CaO) and calcium hydroxide (Ca(OH)2), European Commission, DG Employment, Social Affairs and Equal Opportunities, SCOEL/SUM/137 February 2008, see section 7.2.2 of the technical dossier), it is proposed to classify the substance as irritating to the respiratory system (R37, Irritating to respiratory system; STOT SE 3 (H335 - May cause respiratory irritation)).