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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:

There are limited data available on the skin sensitisation potential of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess). In order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substance is conducted.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).

One key study in guinea pigs on the skin sensitisation potential of D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) (30% C16/C18-APG and 70% C16/C18 fatty alcohols) according to the Buehler method (OECD guideline 406) is available (Henkel, 1993). In this GLP-study, 20 females were exposed to the test substance at a concentration of 50% in water during the induction phase. A control group was treated with the vehicle only. No skin sensitising effects were observed in any treated or control animals after treatment with the test substance at concentrations of 50% at challenge and 25% at rechallenge, respectively. Under the conditions of this study, the test substance was not considered to be a skin sensitiser.

Further studies are available for hexadecan-1-ol (CAS 36653-82-4), octadecan-1-ol (CAS 112-92-5), D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, and D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1), which support a non-sensitising potential of the substance to be registered.

The alcohols hexadecan-1-ol and octadecan-1-ol were tested under similar conditions in a GPMT according to OECD 406 and in compliance with GLP (SafePharm, 1996 a and b). In these experiments, guinea pigs were intradermally and epicutaneously induced with 1% and 50%, respectively, of the test substances in arachis oil and challenged with 25% or 50% of the test substance in arachis oil on respective flanks. No effects on skin were observed after treatment in any of the animals tested. Based on these results, hexadecan-1-ol and octadecan-1-ol were not sensitising to skin.

A GPMT with the category member D-Glucopyranose, oligomeric, C10-16-alkyl glycosides according to OECD 406 is available (Henkel, 1988). The animals were induced intradermally and epicutaneously with 0.1% and 10%, respectively, of the test substance in propylene glycol. At the 24 and 48 h examination, slight irritation was provoked by the challenge treatment with the test substance at 1.25% in 1/20 of the animals of the control groups, but not in the treated groups. At 2.5% challenge concentration, slight erythema were apparent in 3/20 animals of controls and 1/20 of the test group animals at the 24 h reading. At the 48 h examination, slight erythema were observed in 1/20 animals of the control and treated group, respectively. Based on these results, D-Glucopyranose, oligomeric, C10-16-alkyl glycosides had no sensitising effect on guinea pigs under the chosen experimental conditions.

No effects on skin sensitisation were also reported in a LLNA assay with the category member Decyl octyl glycosides at concentrations of 1, 3 and 10%, respectively (Zeneca, 1993). However, documentation of that study was too limited for assessment.

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

Justification for selection of skin sensitisation endpoint:
There is only one study available.

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-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) and for structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, 1.5 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.