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:

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

Two of the three key studies used a protocol similar to OECD guideline 406 (maximisation test method) and were not performed to GLP. In the first, the test material (Lial 145) was dissolved at an undisclosed concentration in Freund's complete adjuvant for intradermal induction; it is unclear whether a vehicle was used for occlusive epicutaneous induction; the challenge application was 100% occlusive epicutaneous. No skin reactions were seen (0/20 at 24 and 48 hours after challenge) (Biolab 1984c).

In the second, corn oil was used as the vehicle for the test material (Dobanol 45) and induction applications were 1% intradermal and 50% occlusive epicutaneous; challenge application was 25% occlusive epicutaneous. No skin reactions were seen after challenge (0/20 at 24 and 48 hours) (Cassidy 1978c).

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 Alcohols C14 -15-branched.

No sensitisation was seen in guinea pig maximisation tests with Alcohols C12 -13 branched and linear (Cassidy 1978c, Sasol 1998e), Alcohols C12-15-branched (Clark & Coombs 1978), Tetradecanol (Iihama 1997b), Hexadecanol (Driscoll 1996a) or Alcohols C16-17 branched and linear (Kern 1998). There were no sensitisation reactions in a human repeated insult patch test with Alcohols C16-17 branched and linear (Pagnoni 2003).

 

The third key study was performed to GLP using a protocol equivalent to OECD guideline 429 (local lymph node assay). A dose-related increase in lymphocyte proliferation in the auricular lymph nodes was seen after application of the test material (Neodol 45) at 1, 10, 25 and 50% in acetone:olive oil 4:1, with stimulation indices of 0.7, 4.0, 9.9 and 16.0 respectively (statistically significant at the top three concentrations). Erythema was noted at the two highest concentrations, which may suggest that the proliferation was caused by irritation (however, the known sensitiser used as the positive control also induced erythema). Positive results were also recorded in this assay when performed with Alcohols C16-17 branched and linear (House 2000).

 

In view of the negative results reported in the guinea pig maximisation test with this multi-constituent alcohol and other related alcohols, a negative result in a human repeated insult patch test on a related material and possible evidence of irritation as a likely confounder in the local lymph node assay, the weight of evidence suggests that Alcohols C14-15-branched is not sensitising.


Migrated from Short description of key information:
In two reliable studies, Alcohols C14-15-branched was not a skin sensitiser in the guinea pig maximisation test (Biolab 1984c, Cassidy 1978c). A number of similar studies with related alcohols were also negative (Cassidy 1978c, Clark & Coombs 1978, Driscoll 1996a, Iihama 1997b, Kern 1998, Sasol 1998e) and no sensitisation was seen in a human repeated insult patch test with Alcohols C16-17 branched and linear (Pagnoni 2003). A mouse local lymph node assay with Alcohols C14-15-branched (and with Alcohols C16-17 branched and linear) was positive, although signs of skin irritation seen at the higher concentrations tested may have confounded the result with Alcohols, C14-15 predominantly linear (House 2000).

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 weight of evidence suggesting a 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 C14-15-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.