Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: estimated data for ADME according to toxicity and physico-chemical data available on the substance
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Materials and methods

Objective of study:
toxicokinetics
Principles of method if other than guideline:
estimated data for ADME according to toxicity and physico-chemical data available on the substance
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
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
Vapor pressure: 3.6 x 10E-4 Pa at 25 ° C
Solubility in water: 674 000 mg / L
Log 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.
Executive summary:

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: 3.6x10E-4 Paat 25 °C
S
olubility in water: 674 000mg/ L
L
og Pow:-2.0 to 20° C - Absorption:
No systemic effecthasbeen observedfollowing oralandtopical administrationin the animal,itis not possibleto concludeonthe potential for absorptionof the substance and/ or itsdegradation productsbyoralor 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:
Thereare no dataon the concentrations ofthe substancein the organs andtissues afterexposure.Thelow logPow (-2.0 to 20° C)suggests that thebioaccumulation potentialis negligible. -Metabolism:In the absence ofeffects of the substanceon the organsincludingthe liverin rats,andin the absence ofinfluence of the additionof a metabolicactivation systemon theresults(negative)of theAmes test,it is notpossible to describewithcertaintythepotentialbiotransformationof thesubstance.However,carbohydratesand their derivatives areusuallymetabolisedbythebody being treated(intheintestinal lumenand/orby the liver)and/orbybacteria from thedigestive tract.
- Excretion:In the absence ofrenal effectsafter oraladministrationof the substanceit is notpossible to concludewith certaintyabout possiblerenal excretionof the substance.However, renalexcretionappears likelybecause ofthe high solubilityof the substancein water (674g/L at 20 °C). Toxicokinetics:There are nodata onplasma levelsof the substancein animalsafter oral administration.