Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

After a pilot study with 5 animals the Guinea Pig Maximization Test (GPMT) was performed in 2010 on 15 female guinea pigs (10 animals for the test item group and 5 control animals) to determine whether the test item Casul-Pulver getrocknet (Etteringit) exhibits skin-sensitising properties. Additional 2 animals were used for dose-finding for the challenge concentration. Intradermal induction: 5%. topical induction: 100%, challenge: 100%. The test item was formulated in sterile 0.9% NaCl-solution.

The challenge led to no skin effect and the animals showed no clinical signs. Under the conditions of this test the test item is not sensitising.

Additional information from the registration dossier of CaSO4:

In a reliable OECD guideline study (NIER 2002) the sensitisation potential of calcium sulfate dihydrate was investigated in male guinea pigs in a Buehler test. All test groups except the positive control had a sensitisation score of 0 (no visable change) for both induction and challenge. Calcium sulfate dihydrate is therefore not considered to be a skin sensitizer.

Migrated from Short description of key information:
A Guinea pig maximization test according to Magnusson and Kligman was performed. Ettringite is considered not to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Additional information from the registration dossier of CaSO4:

There are no specific animal studies to assess respiratory sensitisation but the inhalation study showed no evidence of respiratory sensitisation potential.

Migrated from Short description of key information:
No available information but not expected.

Justification for classification or non-classification

Ettringite was shown to be non-sensitising in a guideline skin sensitisation study in animals and therefore requires no classification under DSD or CLP.