Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are no studies available on the skin sensitisation potential of Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols. 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 following a category approach.

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

Two reliable studies in guinea pigs according to OECD guideline 406 and in compliance with GLP exist that investigate the skin sensitisation potential of the category members D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, and D-Glucopyranose, oligomers, hexyl glycosides.

In the study performed with D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, the induction and challenge treatments were carried out according to the maximisation method (Henkel, 1988). In the induction phase of the study, intradermal injections of the test substance at 0.1% (v/v) in 20% propylene glycol and/or FCA were applied to the clipped skin of 20 females. A control group, consisting of 10 females, was injected with 20% propylene glycol and/or FCA. On Day 8, a 48-hour epicutaneous induction treatment with test substance at a concentration of 10% in undiluted propylene glycol and undiluted vehicle alone was performed in the treated and control animals, respectively, on the regions of intradermal injections. The challenge treatment on Day 22 was performed by topical application of test substance at concentrations of 1.25 or 2.5% to all animals for 24 h. Skin reactions were evaluated 24 and 48 h after the challenge application. 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% test 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.

The effects of the category member D-Glucopyranose, oligomers, hexyl glycosides on skin sensitisation potential in guinea pigs were studied according to the non-adjuvant Buehler method (SafePharm, 1998). In the induction phase, the undiluted test substance was applied to the clipped skin of the left flank of 20 males using an occlusive dressing in 3 repeated exposures. The control group (10 males) was sham-exposed to a blank patch. For challenge exposure, the test substance was applied to the clipped skin of the right flank of all animals at concentrations of 75% (v/v) or undiluted. Skin reactions were evaluated 6, 24, 48 and 72 h after application. No test substance-related systemic effects were observed in the test or control animals. None of the treated animals of the test and control group showed symptoms of dermal irritation after the treatment. The test material therefore had no skin 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 D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1) (Zeneca, 1993).

Based on the negative results of the available studies on category members with alkyl chain lengths ranging from C6 to C16, it may be concluded that Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols do not have a skin sensitisation potential, either.

Migrated from Short description of key information:
Skin sensitisation (OECD 406): not sensitising, based on read-across

Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across based on a category approach and weight of evidence from these studies.

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 substances structurally related to Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols 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; therefore, Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols does not meet the criteria for classification, either, and the data are conclusive but not sufficient for classification.