Registration Dossier

Diss Factsheets

Administrative data

Description of key information

MEG: 2 negative studies

DEG: 1 negative study

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Two studies were conducted to evaluate the allergic contact sensitization potential of Ethylene Glycol in guinea pigs according to procedures described by Magnusson and Kligman. Animals challenged with Ethylene Glycol exhibited no dermal response at challenge to a non-irritating (100%) concentration, as confirmed by a lack of dermal response in irritation control animals and no dermal reactions recorded for test animals. Under conditions of these studies, Ethylene Glycol exhibited no potential to produce dermal sensitization in the guinea pig.

A study was conducted to evaluate the allergic contact sensitization potential of diethylene Glycol in guinea pigs according to procedures described by Magnusson and Kligman. Animals challenged with diethylene Glycol exhibited no dermal response at challenge to a non-irritating (50%) concentration, as confirmed by a lack of dermal response in irritation control animals and no dermal reactions recorded for test animals. Under conditions of these studies, diethylene Glycol exhibited no potential to produce dermal sensitization in the guinea pig.

As both sodium and acetate and found endogenously, it can be reliably assumed that they are not sensitising.

Justification for classification or non-classification

None of the components of this multi-constituent substance show any evidence of sensitising properties and therefore it can be reliably assumed that the substance itself will not have sensitising properties