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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No study with potassic extracts are available. However, several other studies with substances from the sulfate category are available. In a dermal sensitisation study with calcium sulfate, dihydrate, young adult Dunkin-Hartley guinea pigs were tested using the method of Buehler. All test groups except the positive control had a sensitisation score of 0 (no visible change) for both the induction and challenge test. Under the conditions of this test, Calcium sulfate, dihydrate is not sensitizing. In a skin sensitisation study (LLNA) with magnesium sulfate, according to OECD 429, EU B.42 and OPPTS 870.2600 it was shown that the substance is not sensitising. All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted in any of the animals. As magnesium sulfate and calcium sulfate did not induce sensitisation, in a read-across approach, potassic extracts are also considered to be not sensitising.

Migrated from Short description of key information:
Calcium sulfate, dihydrate: no sensitisation, Buehler test (OECD Guideline 406)
Magnesium sulfate: no sensitisation, LLNA (OECD Guideline 429)

Justification for classification or non-classification

According to Directive 67/548/EC and the CLP Regulation no classification of potassic extracts for sensitisation is required based on the present data.