Registration Dossier

Toxicological information

Endpoint summary

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

In this study the test item dissolved in ethanol/water (7:3, v:v) was assessed for its possible contact allergenic potential.

For this purpose a local lymph node assay was performed using test item concentrations of 25, 50 and 100 % by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle only.

All treated animals survived the scheduled study period.

No clinical signs were observed in any animals of the control group or group 2 (25%). About 3 hours after the first topical application, a slight ear erythema was observed at both dosing sites in all mice of group 4 (100%, undiluted), persisting for a total of four days. On the second application day, a slight ear erythema was observed at both dosing sites in all mice of group 3 (50%), persisting for a total of two days.

In this study Stimulation Indices (S.I.) of 1.4, 2.1, and 1.9 were determined with the test item at concentrations of 25, 50, and 100 % in ethanol/water (7:3, v:v), respectively.

The test item was not a skin sensitiser in this assay.


Migrated from Short description of key information:
Polyglycerin (CAS 25618-55-7) was not a skin sensitiser under the described conditions of a Local Lymph Node Assay in mice (OECD 429). Further supporting studies with a similar substance (not containing glycerin) show the same conclusion.

Justification for selection of skin sensitisation endpoint:
study performed according to OECD guideleine and GLP.

Justification for classification or non-classification

Based on all available data the registered substance is not a skin sensitiser and therefore is not subject for classification and labelling requirements.