Registration Dossier
Registration Dossier
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EC number: 261-605-5 | CAS number: 59113-36-9
Endpoint summary
Administrative data
Description of key information
A reliable oral toxicity study in rats (according to OECD 401) with diglycerol has been performed showing an LD50 > 5000 mg/kg bw. A second oral toxicity study in rats (according to OECD 401) with cyclic diglycerol also showed an LD50 > 2000 mg/kg bw. No studies on acute exposure via inhalation or skin are available. A dermal toxicity study performed with glycerol was performed, showing an LD50>2000 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 18 700 mg/kg bw
Additional information
In a limit test (key study) performed according to OECD 401 and GLP, the LD50 of the substance was found to exceed 5000 mg/kg bw. No mortalities or signs of intoxication were observed. No adverse effects on bodyweight and no abnormalities at necropsy were noted. This was supported by a limit study in which the LD50 of cyclic diglycerol was determined to exceed 2000 mg/kg bw. No mortalities or signs of intoxication were observed. No adverse effects on bodyweight and no abnormalities at necropsy were noted.
Acute dermal toxicity was read-across from glycerol. After 8 hour exposure to 6.25 - 18.7 g/kg b.w. glycerin, no deaths occurred in a group of 6 rabbits after occlusive dermal application. No effects of acute toxicity were observed. The LD50 is determined to be >18.7 g/kg b.w.
Justification for classification or non-classification
Based on the available data, diglycerol does not have to be classified for acute oral and dermal toxicity according to CLP Regulation (EC) No 1272/2008.
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