Registration Dossier
Registration Dossier
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EC number: 224-235-5 | CAS number: 4259-15-8
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Short description of key information on bioaccumulation potential result:
The physicochemical properties of the test substance, and extensive toxicity studies in animals provide strong support in determining the ADME profile for this substance, and therefore may substitute for the experimentation of in vivo effects.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
With respect to molecular weight (775), low water solubility (8.5 ppm), and Log Kow (3.6), it is concluded that the test material is absorbed in the gastro-intestinal tract after oral administration.
Absorption via skin is expected to be very low, since its high molecular weight impede skin permeability [Guidance Document on Dermal Absorption, European Commission; Health and Consumer Protection Directorate-General.Sanco/222/2000 rev. 7, March 19, 2004]. This is supported by the absence of systemic toxicity in the acute dermal study.
Inhalative exposure is of no relevance due to the low vapor pressure.
Extensive distribution can be assumed from the target tissues identified in a subacute toxicological study. After oral exposure to high doses, kidneys, liver, adrenal glands, etc. have been identified as target organs for toxic effects.
The test material is assumed to be object to hydroxylation, oxidation and reduction mediated by various liver enzymes or intestinal microflora. The metabolites have function groups suitable for conjugation reaction with phase II enzymes.
It can be assumed that elimination of the substance is relevent. Based on its physicochemical properties, bioaccumulation in exposed organisms is not expected.
Discussion on bioaccumulation potential result:
This substance is virtually insoluble in aqueous milieu (water solubility 8.5 ppm), and has a high molecule weight (775) outside the optimal window for intestinal/dermal absorption.The lack of adverse findings following oral dosing (LD50> 3100 mg/kg for acute toxicity; NOAEL 125 mg/kg/d for repeat dose toxicity), or dermal dosing (LD50 > 5000 mg/kg) may be at least partially due to limited gastrointestinal/dermal absorption of the test substance after treatment, and/or a very low index of inherent toxicity for this substance, and/or its metabolite(s).
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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