Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

In the chosen key study for skin sensitization, i.e. a GLP compliant sensitization study in guinea pigs (Draize/Landsteiner), 12 male Hartley guinea pigs were intradermally exposed for ten times (concentration 0.1%) to 3,7-dimethyloct-6-enenitrile over a period of three weeks (Consumer Product Testing, 1980). Two weeks after the last injection, a challenge injection was made with 0.05 mL 3,7-dimethyloct-6-enenitrile (0.1%). No animals with a positive reaction were observed after challenge. 3,7-dimethyloct-6-enenitrile is therefore found to be no skin sensitizer under the chosen testing conditions.

In a supportive study, i.e. a human maximisation test reported from secondary source, a sodium lauryl sulfate pre-treated forearm or back of 25 healthy male and female volunteers was applied under occlusion with 6% of 3,7-dimethyloct-6-enenitrile in petrolatum for 5 alternate-day 48 hour periods (Kligman 1977). Following a 10 day rest period, volunteers were challenged to a different site for a 48-hour period under occlusion. No skin sensitization reactions were observed.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available.

Justification for classification or non-classification

The present data on dermal sensitization do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.