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EC number: 684-206-1 | CAS number: 258864-54-9
Table 1: Mean Ear Thickeness (mm)
a = an increase in ear thickeness of 25% indicates a positive dermal irritation response
Table 2: Mean Stimulation Index
a = SI ≥ 1.6 indicates a sensitizing response
Table 3: Test Article Statistics
*** = statistically significant (p<0.001)
ns = not statistically significant (p>0.05)
In this study the test item Trihexyltetradecylphosphonium chloride was assessed for its skin sensitizing potential using the Local Lymph Node Assay (LLNA) in mice according to OECD TG 442B and under GLP conditions.
Test item solution at different concentrations was prepared in the vehicle acetone : olive oil (AOO, 4:1, v/v). There were no difficulties in administration of the test article or with its adherence to the dosed ears. On Day 2 of the screen, all animals showed signs of toxicity – edema of the face (cheeks) and sagging eyelids. Both animals in each of the 25% and 50% test article dose groups also appeared emaciated and had few feces. Both animals in 50% test article dose group were also lethargic. All animals lost more than 2 grams of body weight by Day 2. The screen was then terminated and the animals were sacrificed.
In the QIT, both animals in each of the 0.5%, 1%, 2.5% and 5% dose group had erythema on and around the ears beginning on Day 3; this was also observed in both animals in the 10% dose group only on Day 2. Edema on the face and ears was observed in one animal in the 2.5% dose group on Day 5 and 6, both animals in the 5% dose group on Days 4 to 6, and one animal on the 10% dose group on Day 4 to 6. One animal in the 10% dose group had edema of the face (cheeks) on Day 2 and 3, lethargy on Day 2 to 6, appeared emaciated on Day 3 to 6, and few feces and piloerection on Days 4 to 6. The second animal in the 10% dose group had edema of the face (cheeks) and lethargy on Days 2 and 3, few feces and appeared emaciated on Day 3, and was found dead on Day 4; this animal lost more than 2 grams. In the surviving animals, a body weight loss was noted but was not significant (<2 grams).
In the main test, all animals survived the in-life phase and were observed to be normal. Ear thickness measurements and individual animal observations indicated that treatment with 0.25% (v/v) of the test article resulted in excessive local dermal irritation. Body weight losses were noted but were not significant (<2 grams).
The SI of the positive Control Group, 25% HCA, was 2.7. The group SI values for the test article were as follows:
Topical application of Trihexyltetradecylphosphonium chloride at 0.25% (v/v) in AOO resulted in an SI value greater than 1.6 (SI>1.6). Therefore, the test article is a dermal sensitizer in the Local Lymph Node Assay with an EC1.6 of 0.14% (v/v).
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