Registration Dossier
Registration Dossier
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EC number: 258-476-2 | CAS number: 53320-86-8
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:
In addition to the negative test results, Laponite has been used for many years in personal care products at low concentrations to provide structure to formulations. In more than 30 years of use in these fields, no data has been found to indicate that this material leads to sensitisation in the general public.
Migrated from Short description of key information:
The study performed assessed the skin sensitisation potential of this substance in mice using the LLNA (Local Lymph Node Assay) to recommended guideline methodology. The test material was considered to be a non-sensitiser under the conditions of the test
Justification for classification or non-classification
Results of the skin sensitisation test (LLNA in mice) showed no indication that the material is a skin sensitiser. Laponite has been used for many years in personal care products at low concentrations to provide structure to formulations. In more than 30 years of use in these fields, no data has been found to indicate that this material leads to sensitisation in the general public. Respirable exposure would not be an expected route for sensitisation for product uses and during the lifetime of the manufacturing facility where dust inhalation might be expected, there have been no incidences of operators developing respirable (or dermal) sensitisation to this substance. Therefore it is concluded that this substance is not a sensitiser either dermally or respirably
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