Registration Dossier
Registration Dossier
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EC number: 701-204-9 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The physicochemical properties of the registered 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 (~1000), low water solubility (<0.1 mg/l), and Log Kow (>10), it is concluded that the test material is minimally absorbed in the gastro-intestinal tract after oral administration. This is supported by the absence of systemic toxicity in the acute oral study (LD50 > 5000 mg/kg)
and in the 28 day and 90 day repeated dose toxicity and combined reproductive/developmental toxicity studies (NOAEL = 1000 mg/kg).
Absorption via skin is expected to be very low, since its high molecular weight will 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 (LD50 > 2000 mg/kg).
Inhalative exposure is of no relevance due to the low vapor pressure (too low to measure analytically).
An assessment of distribution can not be assumed from subacute toxicological study as no effects were observed at doses up to 1000 mg/kg/day.
The test material is assumed to be subject to hydroxylation, oxidation and reduction mediated by various liver enzymes or intestinal microflora. The metabolites have functional 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 insoluble in aqueous milieu (water solubility <0.1 mg/L), and has a high molecule weight (~1000) outside the optimal window for intestinal/dermal absorption. The lack of adverse findings following oral dosing (LD50 > 5000 mg/kg for acute toxicity; NOAEL 1000 mg/kg/d for repeat dose toxicity), or dermal dosing (LD50 > 2000 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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