D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are two studies available investigating the skin sensitisation potential of D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides (CAS 157707-87-4).

In a key study equivalent or similar to OECD guideline 406, induction and challenge treatments were carried out according to the maximisation method (Drug Safety Testing Center, 1988). In the induction phase of the study, intradermal injections of the test substance at 0.6% (w/v) (0.3% AS) in physiological saline and/or FCA were applied to the clipped skin of 20 female Hartley guinea pigs. A control group, consisting of 10 females, was injected with the vehicle only and/or FCA.On Day 8, a 48-hour epicutaneous induction treatment with test substance at a concentration of 20% (w/v) (10% AS) in physiological saline and the vehicle alone was performed in the treated and control animals, respectively, in the regions of intradermal injections. The challenge treatment on Day 22 was performed by topical application of test substance at concentrations of 6% (w/v) (3% AS), 2% (w/v) (1.0% AS) and 1% (w/v) (0.5% AS) to all animals for 24 h. Skin reactions were evaluated 24 and 48 h after the challenge application. No skin reactions were provoked by the challenge treatment with the test substance in any of the control and treated animals. Based on these results, the test substance had no sensitising effect on guinea pigs under the chosen experimental conditions.

No effects on skin sensitisation were reported in a LLNA assay, either, with the test substance at concentrations of 1, 3 and 10% (w/v) in dimethylformamide, which was performed equivalent or similar to OECD 429 (Zeneca, 1993).

Migrated from Short description of key information:
Skin sensitisation (OECD 406): not sensitising

Justification for selection of skin sensitisation endpoint:
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

The available data on skin sensitisation of D-Glucopyranose, oligomers, branched and linear C9-11 -alkyl glycosides do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.