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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Migrated from Short description of key information:
Skin sensitisation study (OECD 429). Kieselguhr soda ash flux calcined is not a skin sensitizer in accordance with the local lymph node assay.

Respiratory sensitisation

Endpoint conclusion
Additional information:

In the key study (Bradshaw 2010) skin sensitisation was assessed using the local lymph node assay. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of10w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a suspension in propylene glycol at concentrations of 10%,5% or2.5w/w. A further group of four animals were treated with propylene glycol alone. The test material was considered to be a non-sensitiser under the conditions of the test.

Justification for classification or non-classification

Kieselguhr soda ash flux calcined was not considered to be a skin sensitiser in the LLNA and therefore does not warrant classification in accordance with CLP .