Registration Dossier
Registration Dossier
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EC number: 915-741-3 | CAS number: 25618-55-7
Endpoint summary
Administrative data
Description of key information
Two acute oral toxicity studies on rats with Polyglycerol-3 are available.
An acute dermal toxicity test is available with the read-across substance glycerol (see "Read across report" attached to the dossier).
Key value for chemical safety assessment
Additional information
Acute oral toxicity
- Key study: the acute oral toxicity of Polyglycerol-3 was investigated in 5 male and 5 female Wistar rats. A single oral dose of 2000 mg/kg b.w. was administrated to all rats. According to requirements of the limit test, the LD50 values 24h and 14 days were above 2000 mg/kg b.w. (males and females).
- Supporting study: The LD50 of the test material in the female Sprague-Dawley CD strain rats was estimated as being greater than 2000 mg/kg b.w.
Acute dermal toxicity:
- Key study: the test is done with the read-across substance Glycerol. After 8 hour exposure to 6.25 - 18.7 g/kg b.w. glycerin, no effects of acute toxicity were observed. The LD50 is greater than 18.7 g/kg b.w.
Other studies on acute toxicity with a read-across substance glycerol (OECD SIDS dossier of glycerol, page 12 -14)
The OECD SIDS dossier on the read-across substance glycerol refers to the publication of Hine 1953 which states that no deaths were observed in a group of 6 rabbits after occlusive dermal application for 8 hours of synthetic or natural glycerol at 18,700 mg/kg bw. (OECD SIDS document attached to this dossier, page 12).
Glycerol is of very 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 is available. No information is available on the acute toxicity of inhaled glycerol (OECD SIDS dossier on glycerol, page 14).
Justification for classification or non-classification
Since no adverse acute effects were observed in the available test, the substance does not have to be classified.
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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