Registration Dossier
Registration Dossier
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EC number: 909-092-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test material has been tested for skin sensitization in vitro (DPRA, hClat, Lu-Sens) and as a follow-up assay in the LLNA (OECD 429). Tests were performed under GLP and with the same batch.
In-vitro testing showed depletion of the Cystein-Peptide and an increase in CD54 -expression in the dentritic cell line. In contrast, in-vivo testing showed absence of a skin sensitizing potential. In-vivo testing could be performed with high doses ( 5%, 10% und 30 % (w/w) in propylene glycol) since the test material was not irritating and the highest dose determined by the paste that could be applied.
The difference in the results and the correct identfication of the substance as a non-sensitizer can be explained from the nature of the test material. The UVCB substance consists mostly of aluminium salts with organic anions. As a metal compound, the test material was out of scope for the direct peptide binding assay and the OECD TG 442C actually advises that metal compounds give false positive results. Non-covalent interactions between Al3+ and peptides or proteins are vastly described in the literature. In addition, aluminium salts are routinely added to vaccines as adjuvants to boost the immune response. This mechanism is not an allergic reaction, but it is has been shown for another adjuvent, that human moncytes will respond with induction of surface markers such as CD54 and CD86 (Vaccine.2010 Jul 12;28(31):4945-54
Immunomodulatory and adjuvant activities of a polysaccharide extract of Ganoderma lucidum in vivo and in vitro.)
The potency of the test material in the monocyte assay (as determined by CD54 induction) can therefore be explained by the adjuvant-mode of action of the Al3+ in the test material.
No result was produced from the LuSens cells since the test material was highly cytotoxic.
Overall, the test material was not skin sensitizing in the local lymph node assay (OECD 429, GLP) and was out of the applicability domain of the in-vitro studies. Positive results in two in-vitro studies can be attributed to mode of actions not related to the induction of skin sensitization.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification,Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental in-vivo test data (OECD 429) are reliable and suitable for classification purposes under Regulation 1272/2008. The substance was found to be non-sensitizing as no increase in the stimulation indeces were observed. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.
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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