Registration Dossier
Registration Dossier
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EC number: 200-289-5 | CAS number: 56-81-5
Endpoint summary
Administrative data
Description of key information
The acute oral LD50 was determined in three species, rat, mice and guinea pigs. In all three species the oral LD50 was >/= 11,500 mg/kg.
The acute dermal toxicity of glycerin was examined in guinea pigs.
The dermal LD50 was determined to be 45 ml/kg (56,750 mg/kg) in guinea pigs.
In an inhalation study, rats were exposed to aerosol from test material at targeted concentrations of 1.0, 2.0, or 4.0 mg glycerol/L for 6 hours. The 4 h inhalation LC50 was determined to be above 5.85 mg/L in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 11 500 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 5.85 mg/L air
- Physical form:
- inhalation: aerosol
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 56 750 mg/kg bw
Additional information
Glycerol is essentially non-toxic following acute administration.
In the available evaluations performed by official bodies (MAK 2007, OECD 2002, EFSA 2017) a number of additional acute toxicity studies were evaluated and summarised.
All considered glycerol to be of low acute toxicity to mammals. The range of acute oral LD50 values derived from studies in experimental animals is between >4,000 and < 38,000 mg/kg, with the majority of values being between 23,000 and 38,000 mg/kg. For acute dermal toxicity a single LD50 of >18,700 mg/kg for rabbits was summarised by the OECD. The low level of acute toxicity in rodents is further supported by the results of the Danish (Q)SAR Database (LD50 rat oral 7500 mg/kg, LD50 mouse oral 13,000 mg/kg). There was no new relevant information identified up to and including 2021 (most recent literature research).
(Q)SAR predicted profile for glycerol CAS -Nr 56-81-5, Danish (Q)SAR Database, http://qsar.food.dtu.dk Date: 09-02-2021
Glycerin [MAK Value Documentation in German language, 2007]
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
Justification for classification or non-classification
There is no justification for classification based on data from available studies.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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