Registration Dossier
Registration Dossier
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EC number: 407-250-3 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
The substance is a solid and has a high solubility in water.
However, the high molecular weight and the absence of adverse findings indicate that absorption via the gastro-intestinal tract is very low. Furthermore, penetration of the dermis is also unlikely. The present data indicate that bioavailability is very low and systemic toxicity therefore not present The low proportion of particles able to reach the lower respiratory tract in the context with the results obtained after oral administration suggest that there is no concern of a risk after exposure via the inhalation route.
2. Available data from Acute-Toxicity studies and Repeated-Dose Toxicity (RDT) studies?
- Evidence for systemic availability? Describe information derived from acute toxicity studies and RDT-studies
- Describe the different routes of application used and effects if applicable, e.g. mortality, LD50-values, doses/concentrations applied and effects (changes in organ weights etc., in general effects underlining systemic availability
- Describe clinico-chemical and pathological effects (e.g. target organs)
3. Adsorption/Distribution/Metabolism/Excretion (ADME)
- General: compare different routes of exposure (oral/dermal/inhalative), describe information on the relevant routes from available actue and RDT-studies
- Are effects on kidneys etc. reported possibly indicating systemic effects on organs reflecting distribution and excretion?
- Information on “possible” metabolism derived fomt the chemical structure (only limited without information/expert judgement from GV/T Toxicokinetic Departement): e.g. hydrolysis of ester-bonds, Cyp450-linked oxidation of heterocyclic ring-system and conjugation, etc.
- Data on substance-reactivity from mutagenicity studies (e.g. Ames test), occurrence of reactive metabolites (+/- S9 liver homogenate supernatant)?
- Reactivity with macromolecules
- Bioaccumulation? Information available from RDT-studies, logPow?
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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