Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
A basic toxicokinetics assessment for PLGS5 is attached following ECHA guidance 7c (2014). Oral absorption is most likely, whereas respiratory and dermal absorption are considered unlikely or limited. Distribution in the body is likely but limited, and elimination via the bile is considered to be responsible for the slight to moderate toxicity. Accumulation potential is therefore considered to be unlikely.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 90
- Absorption rate - dermal (%):
- 30
- Absorption rate - inhalation (%):
- 10
Additional information
A basic toxicokinetics assessment for PLGS5 is attached following ECHA guidance 7c (ECHA Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance, November 2014 Version 2.0). The substance is an UVCB consisting mainly of C16-18 chains. The compound is liquid with a molecular weight between 326 and 396 g/mol and low water solubility between 0.0000013 and 0.056 mg/L g/L. The log Pvaries between 5.6 and 10.1. The vapour pressure is low between 0.0002 and 0.001 Pa or 1.50 and 7.50E-06 mmH.
Absorption of PLSG-5 was assessed as follows:
- Oral/GI absorption: Based upon the molecular structure and weight, high logKow, enzymatic fragmentation and toxicological profile, oral absorption is most likely.
- Respiratory absorption: Based upon the low vapor pressure, evaporation and inhalation of the substance is unlikely. Deposition in the airways is therefore assumed to be absent and absorption by inhalation is considered to be negligible.
- Dermal absorption: Most of the physicochemical and toxicological parameters are not in favour of dermal absorption. Dermal absorption is considered to be less likely than oral absorption. This is supported by estimations of dermal penetration (Kp), dermally absorbed dose (DAD) and Maximum flux at which a chemical can cross the skin (Jmax).
Distribution, metabolism and excretion of PLSG-5 were assessed as follows:
- Distribution: Based upon the high Log P and target organs (liver and kidney), distribution is likely. However water solubility is limited and no severe signs were observed, therefore concentrations in blood and tissues are considered to be low.
- Metabolism & excretion: Except for the adipose tissue, there is no direct indication of bioaccumulation potential.
- Excretion: Excretion via the bile, breast milk and exfoliation might be expected because of the high log P.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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