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:

There are no data available that address the sensitization potential of isooctanol. However, data are available for isodecanol and other related alcohols which are acceptable for use as read-across.

 

Isodecanol was administered in a modified Draize test to 10 male and female guinea pigs.  Following a preliminary irritation test, 10 Hartley guinea pigs were treated by intradermal injection (0.01 ml) to induce sensitization and challenged two weeks later by both intradermal injection and topical application (0.01 ml). No indication of sensitization was noted.

 

Human volunteer studies with related alcohols showed little evidence of dermal sensitization. Maximization testing was conducted using five 48-hour covered patch tests over a 10-day period followed by a challenge test 10-14 days after the induction phase. The alcohols tested included 2-ethylhexanol (29 volunteers, 4% 2-ethylhexanol in petrolatum), undecanol (25 volunteers, 4% in petrolatum), and 1-dodecanol (25 volunteers using 4% in petrolatum). Patch tests in eczema patients with 5% and 10% 1-dodecanol in petrolatum showed local reactions in 4/1664 and15/1664 subjects, respectively. Details on the type of observed skin reactions were not provided. As pointed out by BIBRA, interpretation of these results is complicated by the fact that no data are available on the irritancy potential of these concentrations on human skin.

Respiratory sensitisation

Endpoint conclusion
Additional information:

There are no data on respiratory sensitization for the higher alcohols. Inhalation exposure to the higher alcohols is unlikely because of the low vapor pressure of these materials at standard temperature and pressure.


Justification for classification or non-classification

No classification for sensitization is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.