Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
Categories
- Category name:
- Phthalamates and Phthalamides
Justifications and discussions
- Category definition:
- Selected terephthalamic esters and terephthalamides, along with terephthalamic acid and C6-8 amides, corresponding to the breakdown products of the amide.
- Category description:
- not applicable
- Category rationale:
- “Read-across” can be utilized to fill data requirements for the registered substance, Pentamid KH (TM), EC 934-047-1, based on two approaches. The first and most basic relates to the presence of common breakdown products or metabolites in biological systems. This is according to Regulation EC No. 1907/2006, Annex XI, Section 1.5, Grouping of substances and read-across; Guidance, Grouping of substances and read-across (ECHA, 2013); and the Read-Across Assessment Framework (AARF, ECHA, 2015). This approach allows the standard testing regime to be adapted when valid data on a metabolic precursor or breakdown product are available. These data are applicable to endpoints pertaining to mammalian systemic toxicity. The second approach relates to mammalian toxicity endpoints which do not involve metabolism; rather, are applicable to topically or dermally applied substances.
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.
