Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
other: Assessment based on available information
Title:
Unnamed
Year:
2013

Materials and methods

Objective of study:
other: A toxicokinetic assessment has been performed based on physical chemical properties of the substance and available open literature.
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A toxicokinetic assessment has been performed based on physical chemical properties of the substance and available open literature.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
glycerol formal
IUPAC Name:
glycerol formal
Radiolabelling:
no

Administration / exposure

Route of administration:
other: oral, dermal, inhalation

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: Based on the available data, oral, dermal and inhalation potenial absorption rates are are set to 100%
Based on the available data, oral, dermal and inhalation absorption rates are set to 100% for risk assessment. GF has no potential for bioaccumulation with log Kow <4.
Executive summary:

ABSORPTION

The partition coefficient of glycerol-formal is -0.99 with an estimated water solubility of 500 mg/L. This property of the substance is favorable for absorption.

- Oral/GI absorption

Low molecular weight of the substance is favorable for absorption. And the moderate log Kow value is favorable by passive diffusion. 

For risk assessment purposes, the oral absorption is set at 100%. The results of the toxicity studies do not provide reason to deviate from this proposed oral absorption.

 

- Respiratory absorption-inhalation

With a vapor pressure of 0.03 kPa, GF shows a low volatility. The moderate log Kow value is favorable for absorption directly across the respiratory tract epithelium by passive diffusion. 

For risk assessment purposes, the inhalation absorption is set at 100%. The results of the toxicity studies do not provide reason to deviate from this proposed inhalation absorption.

 

- Dermal absorption

As water solubility is > 10 g/L and the log Kow value is <1, GF may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Dermal uptake is low for this kind of substance. The criteria for 10% dermal absorption as given in the TGD (3) (MW > 500 and log Pow < -1 or > 4) are not met, and hence a dermal absorption of 100% is proposed for risk assessment purposes.

 

DISTRIBUTION

Once absorbed, widely distribution of GF in the body is expected based on its low molecular weight.

 

Accumulative potential

With a log Kow < 4, GF has NO BIOACCUMULATIVE potential.

 

METABOLISM and EXCRETION

Based on the available data, no additional conclusions can be drawn on the metabolism and excretion of GF after dermal and inhalatory absorption.