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
Diglycerol and cyclic diglycerol were determined to be not irritating to skin and eyes. The studies were performed according to OECD guidelines and GLP.
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
In a skin irritation study performed according to OECD 404 and GLP principles, 0.5 ml of Cycl. Diglycerol was applied on the shaved skin of rabbits (semi occlusive coverage). Within the 72 hours of observation no signs of skin irritation at the treated site of any animal were present at any time. The test substance is considered to be non-irritating to the skin of albino rabbit under the conditions of this study.
In a skin irritation test according to OECD guidelines with 6 rabbits under GLP circumstances, very slight oedema was noted at one treated skin site one hour after patch removal. All treated skin sites appeared normal at the 24-hour observation. Diglycerol was found to be not irritating.
Based on the above data, diglycerol is considered to be not irritating to skin.
In an eye irritation test performed according to OECD 405 and GLP, diglycerol was determined to be not irritating to the eyes of rabbits. Minimal redness of the conjunctiva was observed at 1 hour after application. No further irritating effects were observed. A second eye irritation test with diglycerol was performed according to OECD guidelines and GLP principles. No corneal effects were noted during the study. Iridial inflammation was noted in five treated eyes one hour after treatment. No other iridial effects were observed. Minimal to moderate conjunctival redness persisted in two treated eyes at the 24-hour observation. Since effects were minimal to moderate and reversed within 48 hours, the test substance was found to be not irritating to the eyes.
In an eye irritation study performed according to OECD 405 and GLP, cycl. diglycerol was determined to be not irritating to the eyes of rabbits. Slight conjunctival discharge was observed 1 hours after application and the eyes of all three rabbits were free of signs of irritation 24 hours after application.
Based on the above data, diglycerol is considered to be not irritating to eyes.
Justification for classification or non-classification
In view of the available data, diglycerol does not need to be classified for skin or eye irritation according to CLP Regulation (EC) No. 1272/2008.
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