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:

One key skin sensitisation study (Rees, 1996) was identified, in which SHOP C134 in propylene glycol was administered to albino Dunkin-Hartley guinea-pigs (10 male/10 female). 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.


Migrated from Short description of key information:
One key skin sensitisation study (OECD 406) was identified. Alkenes, C11/C13/C14 showed no evidence of sensitisation in guinea pigs. Alkenes C11/C13/C14 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 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

Based on negative results from key skin sensitisation studies, alkenes, C11/C13/C14 are not considered to be a skin sensitizer and 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/C13/C14 are not expected to cause respiratory sensitisation based on results of skin sensitisation and an absence of reactive chemical alerts.