Registration Dossier
Registration Dossier
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EC number: 234-448-5 | CAS number: 12004-14-7
Endpoint summary
Administrative data
Description of key information
No irritating effects were observed in the in vitro and in vivo studies with Ettringite. Ettringite is not considered to be irritating to the skin or eyes/ mucous membranes.
Further data and assessment from CaSO4 according to justification for read across (see separate document in iuclid chapter 13).
Calcium sulfate 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
In the registration dossier of CaSO4 is stated:
Skin irritation
In a reliable OECD guideline in vivo skin irritation study (Canut 1990) 0.5 g calcium sulfate anhydrite was applied to the shaved skin of 3 New Zealand White rabbits under a semiocclusive patch for 4 hours.Animals were observed after removal of the patch at 30 and 60 mins and 24, 48 and 72 h. The average of the erythema and edema assessments for the 3 animals after 72 h was 0.0. Calcium sulfate was found to be non-irritating to the skin in rabbits.
Eye irritation
In a reliable OECD guideline in vivo eye irritation study (Canut 1990) 100 mg calcium sulfate anhydrite was instilled into the eyes of 3 New Zealand White rabbits. Ocular observations were made at 1, 24, 48 and 72 h after instillation. Grade 1 and 2 conjunctival hyperaemia as well as grade 1 chemosis were observed 24h after application, which fully recovered within 72h in two of three animals. Taken together, calcium sulfate need not to be classified as irritating to the eyes.
Justification for classification or non-classification
In the in vivo skin and eye irritation studies ettringite as well as calcium sulfate were non-irritant and therefore required no classification under DSD or CLP.
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