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
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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