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:

The key study was performed to GLP using a protocol similar to OECD guideline 406 (Buehler test method). The test material (Neodol 91) was diluted in absolute ethanol and used for induction at 1.01% occlusive epicutaneous; the challenge application was also 1.01% occlusive epicutaneous. No skin reactions were seen in the test group but the guideline requirement for the use of the highest non-irritating concentration may not have been achieved since the next highest concentration tested in the pre-screen, which produced irritation, was 50%. The positive control gave an ambiguous sensitisation response (Cagen 1981b).

 

The supporting study was performed prior to the introduction of GLP using a protocol similar to that of OECD guideline 406 (guinea-pig maximisation test method). Corn oil was used as the vehicle for the test material (Dobanol 91) and induction applications were 0.1% intradermal and 10% occlusive epicutaneous; challenge application was 5% occlusive epicutaneous. No skin reactions were seen after challenge (Cassidy & Clark 1978).

 

The test material was not a skin sensitiser under the conditions of these tests. The absence of sensitisation for other tested alcohols supports the view that these chemicals are not skin sensitisers.

In some cases the CAS and chemical identity stated refer to the 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:
In two reliable studies, conducted using protocols similar to OECD guideline 406, Neodol 91 and Dobanol 91 were not skin sensitisers in guinea pigs in Buehler or maximisation tests (Cagen 1981b, Cassidy & Clark 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, Alcohols C9-11 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.