Alkenes, C11-14

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Two read-across skin sensitisation studies were identified, one from alkenes, C11/C13/C14 and another from alkenes, C11-15. For alkenes C11/C13/C14, SHOP C134 in propylene glycol was administered to 10 male and 10 female albino Dunkin-Hartley guinea-pigs (Rees, 1996). Animals were tested by the Magnusson-Kligman Maximisation Test. Twenty guinea pigs (10 male; 10 female) received an intradermal injection of 50% SHOP C134 in propylene glycol. Seven days later the animals were dermally treated in the same area with 100% SHOP C134 (as supplied) and the site was covered with an occlusive dressing for 48 hours. A challenge dose of either 1% or 0.3% SHOP C134 in propylene glycol was dermally administered on day 22, again with occlusive dressing. Test sites were then assessed 24 and 48 hours later.

The intradermal injection of 50% SHOP C134 in propylene glycol caused slight to moderate erythema and discoloration. Undiluted SHOP C134 applied dermally caused exfoliation and loss of flexibility. After the challenge dose, 3 of 10 controls and 6 of 20 test animals treated with 1% SHOP C134 had slight erythema. There were no reactions after challenge with 0.3% SHOP C134 or propylene glycol. Under the conditions of this study, repeated applications of SHOP C134 did not cause delayed contact hypersensitivity in the guinea-pig.

 

In a second read-across study from alkenes, C11 -15, Internal Olefin 114 LP11 in corn oil was administered to 10 male and 10 female guinea pigs using the method of Magnusson and Kligman (Cassidy and Clark, 1977). Using a scoring method of -ve, trace, +ve, and ++ve, erythema responses to the topical challenge dose was tabulated. Based on these results, Internal Olefin 114 LP11is not a dermal sensitiser.

Migrated from Short description of key information:
Two read-across skin sensitisation studies were identified, one from alkenes, C11/C13/C14 (equivalent to OECD 406) and another from alkenes, C11-15 (non-guideline; animals evaluated by Magnusson and Kligman method). Both studies showed negative results when test materials were evaluated in guinea pigs. Alkenes, C11-14 are not dermal sensitisers and contain 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 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 and an absence of reactive chemical alerts.

Justification for classification or non-classification

Negative results from skin sensitisation studies with alkenes, C11/C13/C14 and alkenes, C11-15 (both structural analogues) were read-across to alkenes, C11-14. It was therefore inferred that alkenes, C11-14 would also not be a skin sensitizer. Therefore, alkenes, C11-14 do not meet the criteria for classification as a dermal sensitizer under EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008. 

Alkenes, C11-14 are not expected to be respiratory sensitisers based on results of skin sensitisation testing and an absence of reactive chemical alerts.