Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Toxicokinetics basic parameters can be estimated according to physico-chemical and toxicity data available on the registered substance.
Possible oral absorption
Low dermal absorption
Low absorption rate by inhalation

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

Toxicokinetics basic parameters can be estimated according to physico-chemical and toxicity data available on the registered substance.

Physico-chemical parameters: Molecular weight: 387 + 134 + 152
Physical state
: compact waxy paste
V
apor pressure: 3.6 x 10E-4 Pa at 25 ° C
S
olubility in water: 674 000 mg / L
L
og Pow: -2.0 to 20 ° C - Absorption:
No systemic effect has been observed following oral and topical administration in the animal, it is not possible to conclude on the potential for absorption of the substance and / or its degradation products by oral or dermal route. Furtermore, the substance is not irritating to the skin. According to ECHA guidance - Chapter R7C, if water solubility is above 10000 mg/l and the log Kow value below 0 the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Dermal uptake for these substances will be low. - Distribution:
There are no data on the concentrations of the substance in the organs and tissues after exposure. The low log Pow (-2.0 to 20 ° C) suggests that the bioaccumulation potential is negligible. - Metabolism: In the absence of effects of the substance on the organs including the liver in rats, and in the absence of influence of the addition of a metabolic activation system on the results (negative) of the Ames test, it is not possible to describe with certainty the potential biotransformation of the substance. However, carbohydrates and their derivatives are usually metabolised by the body being treated (in the intestinal lumen and / or by the liver) and / or by bacteria from the digestive tract.
- Excretion: In the absence of renal effects after oral administration of the substance it is not possible to conclude with certainty about possible renal excretion of the substance. However, renal excretion appears likely because of the high solubility of the substance in water (674 g / L at 20 ° C). Toxicokinetics: There are no data on plasma levels of the substance in animals after oral administration.