Registration Dossier
Registration Dossier
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EC number: 458-930-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
JUSTIFICATION OF WAIVING
1. The evaluation of the toxicokinetics of Ceraphyl 55 shows that based on its physicochemical properties, exposure to Ceraphyl 55 through inhalation is very unlikely, while absorption via the dermal route is rather limited. Also no significant absorption of Ceraphyl 55 is expected after oral uptake.
2. The major part of Ceraphyl 55 is expected to be excreted without being absorbed or being metabolized. Ceraphyl 55, an odd-numbered pivaloyl ester, is very stable and resistant toward enzymatic and chemical hydrolysis.This evaluation is supported by the low toxicity of Ceraphyl 55 in acute and repeated dose toxicity tests in rats.
3. Exposure related waiving is supported by the fact that Ceraphyl 55 is only applied in an industrial environment with sufficient prevention of exposure through inhalation or skin. Combined with the fact that its physicochemical properties limit absorption to almost zero in case of possible exposure, the risk of significant exposure leading to any possible effects on reproduction is negligible.
4. Considering the exclusive end-use of Ceraphyl 55 in cosmetic products, firstly, customer exposure does not fall within the scope of REACH and secondly, animal testing for Reproductive and developmental toxicity is no longer allowed in the context of the Cosmetic Directive 76/768/EEC (from 11 March 2013).
Justification for classification or non-classification
Additional information
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.
