Registration Dossier

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:

No key or supporting studies were available on Undecanol linear and branched.

 

The Category hypothesis is that the long chain linear aliphatic alcohol family has at its centre an homologous series of increasing carbon chain length, which is associated with a consistency and predictability in the property data across the group, for the physicochemical, environmental and toxicological property data sets. In view of the structural and chemical similarities, it is considered that the results from a number of reliable skin sensitisation studies on single- or multiple-constituent alcohols with appropriate chain lengths can be read across to Undecanol linear and branched.

 

No sensitisation was seen in guinea pig maximisation tests with Alcohols C7 -9 linear and branched (Cassidy & Clark 1978b, Rees 1996c), Alcohols C9 -11 linear and branched (Cassidy & Clark 1978), Dodecanol (Iihama 1997a), Alcohols C12 -13 branched and linear (Cassidy 1978c, Sasol 1998e, Vinegar 1976) or Alcohols C12-15 branched and linear (Clark & Coombs 1978). Negative results were also reported in guinea pigs in a Buehler test with Alcohols C9-11 branched and linear (Cagen 1981b) and in a modified Draize test with Hexanol (Sharp, 1978).

 

A weak sensitisation reaction was seen in a modified Draize test in guinea pigs treated with Decanol (Sharp, 1978) and positive results were reported in a guinea pig maximisation test with Alcohols C12-13 branched and linear, although some protocol deviations were noted in this study (Ritz 1980). In some cases the CAS and chemical identity stated refer to SDA nomenclature for this substance. in REACH substance identification it is necessary to be more specific as to the chain lengths present. Full details may be found in the CSR

Migrated from Short description of key information:
No sensitisation studies were available on Undecanol linear and branched. A number of related alcohols were not skin sensitisers in guinea pig maximisation tests (Cassidy 1978c, Cassidy & Clark 1978, Cassidy & Clark 1978b, Clark & Coombs 1978, Iihama 1997a, Rees 1996c, Sasol 1998e, Vinegar 1976) and no sensitisation was seen in a human repeated insult patch test with Alcohols C16-17 branched and linear (Pagnoni 2003). Some positive results were also seen with related materials (Ritz 1980, Sharp 1978).

Respiratory sensitisation

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

The test material contains no structural groups suggestive of respiratory sensitisation and, together with the lack of skin sensitising potential, it is unlikely to be a respiratory sensitiser.


Migrated from Short description of key information:
no data

Justification for classification or non-classification

Based on the available data, Undecanol linear and branched would not be classified as a skin or respiratory sensitiser under Regulation (EC) No. 1272/2008 (CLP) or Directive 67/548/EEC (DSD). Tests on similar substances included in this category are also supportive of these results, which do not warrant classification for sensitisation under DSD or GHS criteria.