Registration Dossier
Registration Dossier
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EC number: 427-370-1 | CAS number: 164288-56-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Thanks to the manufacturing process and the risk management measures, the exposure to the notified substance is quite improbable. Consumers might be exposed to the notified substance exclusively via cosmetic use containing the marketing form MONTALINE C 40 at different concentrations. Moreover, for one decade (1997 to 2007) 905 tons of MONTALINE C 40 (i.e. the 40% aqueous dilution) has been selling within them 437 tons in cosmetics. Only a MK test (OECD 406) was available at that moment.
Then 4 cases of dermatitis were reported in leave-on products at 2%, forcing the company to investigate more this end point always on the marketing form in clinical test and according to the 1st intention test (LLNA OECD 429).
MONTALINE C 40 (i.e. a 40% aqueous solution) revealed a non-irritating potential at 2.5-10% but irritant from 25-100% in the LLNA test. On the regulatory point of view, the EC3 should be higher than 10%. An increase of 1.8 times the weight of the lymph nodes in the treated group at 10%. Pursuant to precautionary principle, 2.5% has been selected as maximum concentration without any alert. Moreover, a clinical data reinforces the confidence on the tolerance at 7% in volunteers.
Thus, considering a weight of evidence strategy, the notified substance deserves the labelling as skin sensitizer.
Migrated from Short description of key information:
Several data have been performed (i.e. chronologically speaking OECD 406, HRIPT at 7% and OECD 429) in view of assessing the skin sensitizing properties of the notified substance.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
Worker exposure during to manufacturing and formulation is minimal as the blending/dispensing process will employ a closed, sealed-delivery system, mask, and ventilation systems.
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
