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 were no identified key sensitisation studies for icos-1-ene. Read-across studies from octadec-1 -ene and C20 -24 alpha olefins were used to assess skin sensitisation. For octadec-1-ene, 10 male and female Hartley albino guinea pigs were treated with Neodene-18 alpha olefin to determine its skin sensitisation potential using the Buehler Technique (Morris, 1992).

 

The study authors reported that following the primary challenge at a concentration of 2.5%, there were no grades of 1 produced in the test or control animals. The incidence of grade+(numerical values of 0.5) responses in the test group (total 10 animals out of 19) was compared to the naïve control group (6 out of 10; one animal dead at the 48 hours observation period). Based on these results, the authors concluded that the incidence and severity of these responses in the test group were essentially comparable to those produced by the naïve control group indicating that sensitization had not been induced.

In a read-across skin sensitisation study from C20-24 linear alpha olefin, Neodene C20-24 alpha olefin was tested for its potential to induce skin sensitisation (delayed contact hypersensitivity) with repeated dermal application under occlusive conditions in male and female Harlan albino guinea pigs using the Buehler method (Morris, 1992).Animals were exposed to 0.3 millilitres test material 1 day/week for 6 hours/day for 3 weeks. Following a 2 week rest period, animals received a challenge dose in the same manner as the initiating doses.  For the three weekly induction doses, a warmed, undiluted Neodene 20-24 alpha olefin (specified as undiluted in acetone) was used; the primary challenge dose was a 5% W/V solution of Neodene 20-24 alpha olefin in mineral oil.  Reactions were scored with a numerical grade to indicate severity. Historical laboratory data indicated that the positive control substance, 2,4-dinitrochlorobenzene produced the appropriate response in previous studies. Neodene 20-24 alpha olefin caused little or no irritation after the challenge dose and did not induce a delayed contact hypersensitivity reaction under the conditions of the study. In this study, Neodene 20-24 alpha olefin is not a dermal sensitiser.

Migrated from Short description of key information:
Two read-across skin sensitisation studies were identified, one from octadec-1-ene (OECD 406) and another from C20-24 alpha olefin (OECD 406, Federal Insecticide, Fungicide, and Rodenticide Act, and the Toxic Substances Control Act ). Octadec-1-ene and C20-24 alpha olefin did not produce skin sensitisation effects in guinea pigs. Icos-1-ene is not a dermal sensitiser and contains no chemical alerts for respiratory sensitisation.

Respiratory sensitisation

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

Not expected to cause respiratory sensitisation based on results of skin sensitisation testing and an absence of reactive chemical alerts.


Migrated from Short description of key information:
Not expected to cause respiratory sensitisation based on results of skin sensitisation testing and an absence of reactive chemical alerts.

Justification for classification or non-classification

Icos-1-ene is not classified for skin sensitisation as defined by EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008 (GHS aligned) based on overall evaluation of two dermal sensitisation studies with linear alpha olefins. Icos-1-ene is not expected to be a respiratory sensitizer based on results of skin sensitisation studies and an absence of reactive chemical alerts.