Registration Dossier
Registration Dossier
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EC number: 306-797-4 | CAS number: 97404-33-6
Endpoint summary
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:
A reliable local lymph node assay was conducted with Decyl octadec-9 -enoate (CAS No. 3687 -46 -5) according to OECD Guideline 429. The test substance was applied at 25, 50 and 100% on 3 consecutive days to the dorsum of both ears of 5 female CBA mice each. Five days later the animals received approximately 20µCi of Decyl octadec-9 -enoate and were sacrificed 5 hours later for measurement of radioactivity.
No significant increase in isotope incorporation was detected after repeated application. The stimulation index, calculated by comparison of the Cpm of the control and the treated animals, was 1.2 for the 25% application, 2.0 for the 50% and 2.1 for the 100% application. Thus, based on this result Decyl octadec-9 -enoate was concluded not to be a sensitizer.
A Guinea pig maximisation test was performed with Decyl octadec-9-enoate (CAS No. 3687-46-5) according to OECD Guideline 406. 19 females in the test group and 10 females in the control group (Pirbright-White guinea pigs) were induced intradermally and by the epicutaneous route. Route of challenge was by epicutaneous (open). The body weight of the animals was within the normal range during the study period. All the animals in the test group and the control animals did not show any signs of a sensitising effect at both reading time points (24 and 48h after challenge reaction), (Gloxhuber, 1979). This study was disregarded due to the lack of information on the test substance concentration.
Migrated from Short description of key information:
Key Study on skin sensitisation was available for (CAS No.):3687-46-5.
Key, Beerens-Heijnen, 2010, LLNA, RL1 –not sensitising.
Justification for classification or non-classification
According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for sensitisation, no classification is required.
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