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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

A round-robin testing program was conducted in 14 laboratories.
The dermal irritation potential was examined.
Glycerin was considered to be non irritating to the skin in rabbit irritation studies in 14 testing laboratories.
In another study with rabbits, glycerin was considered to be non-irritating also.


Glycerol was applied to the skin of 33 humans for 24 hours on a semi-occluded patch and the response to the test material was observed. Under the conditions of the study, Glycerine USP (25% concentration) exhibited no clinical irritation when tested in humans.


 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Glycerol is non-irritating to the skin and eye.


In the available evaluation performed by an official body (OECD 2002) a small number of additional irritation studies were evaluated and summarised.


There were no studies conducted to modern OECD guidelines. The studies showed no signs of dermal irritation to the rabbit skin. Following instillation of glycerol to the rabbit eye, in two studies some minor, transient irritation signs were reported during the first 24 hours. The conclusion was that glycerol is not irritating to the eyes. There was no new relevant information identified up to and including 2021 (most recent literature research).


Glycerol, CAS Number 56-81-5, OECD SIDS Initial Assessment Report For SIAM 14 Paris, France, 26-28 March 2002

Justification for classification or non-classification

There is no justification for classification based on data from available studies.