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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Description of key information

Glycerin was administered by oral gavage to groups of male and female rats through two generations.


There was no effect noted on growth, fertility and reproductive performance through two generations at 2000 mg/kg/day.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
The study has limitations but there was no evidence of any adverse effects on reproductive parameters.
Additional information

Two additional studies were evaluated and summarised by EFSA 2017 (Johnson et al 1933, Guerrant et al. 1947), however these studies were very old and had significant limitations.


No additional relevant studies were summarised by any of the other official bodies (MAK 2007 and 2016, OECD 2002).


The overall conclusion was that the reports of the two- and multigeneration reproductive toxicity studies have limitations but there was no evidence of any adverse effects on reproductive parameters.


There was no new relevant information identified up to and including 2021 (most recent literature research).


 


Re-evaluation of glycerol (E 422) as a food additive, EFSA Journal 2017;15(3):4720


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


Glycerin [MAK Value Documentation in German language, 2007]


The MAK Collection for Occupational Health and Safety 2017, Vol 2, No 2

Effects on developmental toxicity

Description of key information
A developmental toxicity study was conducted in rats, mice and rabbits. There was no effect on developmental toxicity of offspring of female rats dosed with glycerin at doses as high as 1310 mg/kg/day.   There was no effect on developmental toxicity of offspring of female mice dosed with glycerin at doses as high as 1280 mg/kg/day. There was no effect on developmental toxicity of offspring of female rabbits dosed with glycerin at doses as high as 1180 mg/kg/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 180 mg/kg bw/day
Species:
other: rat, mouse and rabbit
Additional information

There is no evidence of a developmental toxicity effect in rats, mice and rabbits. The highest dose levels ranged from 1180 mg/kg/day in rabbits to 1310 mg/kg/day in rats.


 


No additional relevant studies were summarised by any of the official bodies (MAK 2007 and 2016, OECD 2002, EFSA 2017).


The overall conclusion was that there was no evidence of teratogenicity for glycerol. All NOAEL values for several species are above the limit dose given in the OECD Test Guideline.


 


There was no new relevant information identified up to and including 2021 (most recent literature research).


 


Re-evaluation of glycerol (E 422) as a food additive, EFSA Journal 2017;15(3):4720


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


Glycerin [MAK Value Documentation in German language, 2007]


The MAK Collection for Occupational Health and Safety 2017, Vol 2, No 2

Toxicity to reproduction: other studies

Additional information

No additional information available.

Justification for classification or non-classification

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

Additional information