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:

Up to date, there is no valid animal skin sensitization study available or known to exist.

 

In an experimental skin sensitization study with 29 human volunteers using the maximization method of Kligman, no skin sensitization was seen in any of the 29 test subjects (Epstein, 1976). Under the conditions of REACH, the reliability is assessed to be 3 as the method used does not correspond to a standard test guideline, the method is not validated, and the reporting is poor. Nevertheless, the study result indicates that 2-ethylhexanol does not have a sensitizing potential (cf. section 7.10.4).

 

In addition, reliable secondary source information exists that the medical department of a large company did not see any case of sensitization in workers producing large quantities of 2-EH (cf. section 7.10.1).

 

Furthermore, there is no structural alert or experience that would indicate a sensitizing potential for primary aliphatic alcohols (waiver skin sensitisation).

 

Based on combined findings, further testing of the skin sensitization potential of 2-ethylhexanol is scientifically not justified (REACH Annex XI Sect. 1.1.2, Sect. 1.1.3, and Sect. 1.5).

 

Overall, it is concluded that 2-EH lacks sensitizing properties.


Migrated from Short description of key information:
No skin sensitisation was seen in 29 human volunteers in which 2-EH was tested according to Kligman's method (Epstein, 1976).

Justification for selection of skin sensitisation endpoint:
Endpoint conclusion based on data human volunteers presented in section 7.10.4.

Respiratory sensitisation

Endpoint conclusion
Additional information:

To date there is no valid respiratory sensitization study available or known to exist.


Migrated from Short description of key information:
No information avaiable

Justification for classification or non-classification

Available information does not point to a sensitising potential of 2-EH, therefore no classification is required according to Regulation (EC) no 1272/2008.