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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

There were no sensitisation studies available for isomerised olefins; alpha, internal, linear and branched - single carbon number. However, a modified Buehler sensitisation study was available for tridecene, a structural analogue of single carbon number isomerised olefins. Following induction and challenge with tridecene in guinea pigs (Varsho, 1995), no evidence of sensitisation was observed while the positive control produced the expected results. Tridecene is not considered a sensitiser and by analogy, dodecene is not classified or labelled as a sensitiser.

 

Justification for Read Across:

Several criteria justify the use of the read across approach to fill data gaps for single carbon number isomerised olefins using tridecene as an analogue. Tridecene is a single carbon number isomerised olefin; however, it is not a substance included under the Higher Olefins and Poly Alpha Olefins Consortium. However, tridecene’s chemical structure, physico-chemical properties, and mammalian health endpoints are comparable with other single carbon number isomerised olefins. Therefore, read across between tridecene and single carbon number isomerised olefins can be justified.


Migrated from Short description of key information:
One read-across skin sensitisation study (OECD 406) from tridecene was identified. Tridecene showed no evidence of sensitisation in guinea pigs. Dodecene 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

Negative results from a skin sensitization study with tridecene (a structural analogue) were read-across to dodecene. It was inferred that dodecene would also not be a skin sensitizer. Therefore, dodecene does not meet the criteria for classification as a dermal sensitizer under EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008.

 

There are no data available for respiratory sensitization for single carbon number isomerised olefins, including dodecene. Dodecene is not expected to cause respiratory sensitisation based on results of skin sensitisation and an absence of reactive chemical alerts.