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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 (1301), water solubility (<5 mg/L), and Log Kow (>2.59), it is concluded that the test material is absorbed at limited rate in the gastro-intestinal tract after oral administration.

Absorption via skin is expected to be very low, since its high molecular weight and low water solubility 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 of structural analogues, toxic effects were observed in kidneys, liver, adrenal glands, etc.

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 relevant. Based on its physicochemical properties, bioaccumulation in exposed organisms is not expected.

 

Discussion on bioaccumulation potential result:

This substance has a molecular weight of 1301. Modeling calculations predicted very low dermal absorption (LD50 >25600 mg/kg for acute toxicity). Intestinal absorption was expected to be low as well, because no significant adverse effects were observed following oral dosing: LD50 7500 mg/kg for acute toxicity (actual study); NOAEL 125 mg/kg/d for repeat dose toxicity (by read across to analog substance). The lack of adverse effects 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).