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EC number: -
CAS number: -
There were no deaths during the study, and no clinical signs of toxicity
were observed. No signs of irritation were noted at the test sites.
Greasy fur to the head and neck was noted in all animals from Day 1 to
Day 6. There were no effects of treatment on body weight.
Table 1. Scintillation counts and stimulation indices
No. sites yielding lymph nodes
Disintegrations per minute* (DPM)
Disintegrations per minute per node (DLM)
Stimulation Index (SI)
Scintillation fluid with 5% w/v trichloroacetic acid
Test article, 10% w/v
Test article, 25% w/v
Test article, 50% w/v
* All scintillation counts corrected for the blank
The skin sensitisation potential of OLEIC_DimerFA_TETA_PAA was evaluated
in the Local Lymph Node Assay (LLNA), according to OECD Test 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) were 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. Therefore,
OLEIC_DimerFA_TETA_PAA is considered to be a skin sensitiser in the
LLNA. On the basis of these results, OLEIC_DimerFA_TETA_PAA requires
classification as a Category 1 Skin Sensitiser according to Regulation
(EC) No 1272/2008.
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