Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.