Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: Assessment based on available information
Adequacy of study:
key study
Study period:
May 2021
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
according to (EC) No 1907/2006, Annex VIII, Column I, Section 8.8.1, an assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information is done
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
-
EC Number:
473-690-8
EC Name:
-
Cas Number:
738602-93-2
Molecular formula:
not applicable for UVCB
IUPAC Name:
(2R,3R,4S,5S,6R)-2-{[(2R,3R,4R,5S,6R)-5-{[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}oxan-2-yl]oxy}-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2S,3R,5R)-4-{[(2R,3R,4R,5S,6R)-5-{[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}oxan-2-yl]oxy}-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}hexane-1,2,3,5,6-pentol
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
the reported composition and structural information of the constituents is taken into account only. No physical test material was used.

Results and discussion

Main ADME resultsopen allclose all
Type:
excretion
Results:
Giving the high water solubility and the substance consists of glucosides and saccharides, Excretion via urine is rather likely for any substance not metabolised.
Excretion by inhalation is rather unlikely.
Type:
metabolism
Results:
The substance is likely to be fully metabolised, for details, see field "any other information on results incl. tables"
Type:
distribution
Results:
The substance is very hydrophilic and Protein binding is unlikely relevant. For details, see field "any other information on results incl. tables".

Based on the very low partition coefficient, the high water solubility and the assumed readiness for meta
Type:
absorption
Results:
dermal and inhalative absorption are assumed to be low. The substance should be absorbed orally to a high amount. For details, see field "any other information on results incl. tables"

Any other information on results incl. tables

Absorption:


Some components (ca. 10 %) of the UVCB substance are small enough to be absorbed through the skin (Molecular weight below 500 g/mol). The major part of the components has a molecular weight above 500 mg/ml However, the calculated log Pow and the measured log Pow are clearly out of range to be readily absorbed. Based on above considerations the substance is unlikely to be absorbed through the skin in relevant amounts (none of the following apply: molecular weight < 500 g/Mol, -1 < log POW < 4, see EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRETORATE-GENERAL: Guidance Document on Dermal Absorpiton Sanco/222/2000 rev. 7 19 March 2004).


For exposure assessments a value of 10 % of absorption after dermal exposure may be appropriate.


 


Uptake by inhalation after evaporation is unlikely, the substance is a liquid at room temperature and has a very low vapour pressure.


For exposure assessments a default value of 10 % of absorption via inhalation may be appropriate.


The absorption after oral ingestion cannot be calculated due to lack of data; by default absorption of 100 % may be appropriate, until specific data will be available.


 


Distribution:


The substance is very hydrophilic and Protein binding is unlikely relevant. The high water solubility may lead to a low distribution volume. Therefore distribution to specific organs is depending mainly on blood flow. Crossing of membrane barriers like the Blood/Brain barrier seems unlikely giving the molecular weight and the high hydrophilicity of the substance.


However, as the substance constitutes of polyols and glucosides, specific transfer enzymes may enhance the cellular uptake of constituents of the substance.


 


Metabolism and Excretion:


 


The substance does contain glucosides and saccharides, with the alcohol part of the glucosides being an sugar alcohol. All these constituents are naturally present substances which can be formed and metabolized by the human body by specialised enzymes. Therefore the classically relevant Phase I and Phase II-Metabolism does not apply to the substance.


The components of the substance are likely to enter the general sugar metabolism and being metabolized to Carbon dioxide and Water in the end. As the different oligomers are connected by a 1,4-glycosidic bond, the first step may be the cleavage of this bond to result finally Glucose and Glycitol.


 


Giving the high water solubility and the substance consists of glucosides and saccharides, Excretion via urine is rather likely for any substance not metabolised.


Excretion by inhalation is rather unlikely.

Applicant's summary and conclusion

Conclusions:
Based on available information, the Absorption, Distribution, Metabolism and Excretion of the substance are assessed.