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EC number: -
CAS number: -
The skin sensitisation potential of Fatty acids, C18-unsatd., dimers,
polymers with oleic acid and triethylenetetraminewas evaluated in the
Local Lymph Node Assay (LLNA), according to OECD Guideline 429 and GLP.
A preliminary study was conducted in one female CBA/Ca mouse to
determine concentrations to be used for the main study. Female CBA/Ca
mice (4 per group) where used in the main study. The test material was
prepared for administration at 0, 10, 25 and 50% w/v in 80% v/v acetone
in olive oil. The test material or vehicle control was applied to the
outer aspect of the auditory pinnae of the mice once daily on Days 1, 2
and 3. On Day 6 a 20 µCi dose of tritiated ³H-methyl thymidine was
injected intraveneously into each mouse. Approximately 5 hours later the
auricular lymph nodes were recovered from each animal. Nodes from the
same treatment group were pooled and suspensions of the cellular
components of the lymph nodes were prepared in 5% w/v trichloroacetic
acid and processed through a scintillation counter. The DPM value
(disintegrations per minute in a ten minute period) was used to
calculate the DLM value (disintegrations per minute per lymph node). The
DLM value of each test group was divided by the DLM value for the
vehicle control group to provide the Stimulation Index for each group.
Stimulation indices of 9.9, 9.0 and 8.1 were obtained for test
concentrations 10%, 25% and 50%, respectively. On the basis of these
findings, Fatty acids, C18-unsatd., dimers, polymers with oleic acid and
triethylenetetramine is considered to be a skin sensitiser.
Fatty acids, C18-unsatd., dimers, polymers with oleic acid and
triethylenetetraminewas considered to be a skin sensitiser in the local
lymph node assay. On this basis, the substance meets the criteria for
classification for skin sensitisation as: Category 1, H317 “May cause an
allergic skin reaction” according to Regulation (EC) No 1272/2008 and as
Xi, R43 “May cause sensitisation by skin contact” according to Directive
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