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EC number: 700-255-4 | CAS number: 31775-89-0
Skin sensitisation (OECD 429): skin sensitising
Table 1: Clinical observations, Body weight and mortality data – preliminary screening test
0= No signs of systemic toxicity
Table 2: Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index (SI)
Concentration(%v/v) inacetone/olive oil 4:1
dpm= Disintegrations per minute
a= Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b= Stimulation Index of 3.0 or greater indicates a positive result
na= Not applicable
Table 3: Individual clinical observations and mortality data
Concentration(% v/v) inacetone/olive oil 4:1
Table 4: Individual body weights and body weight changes
Body weight (g)
Body weight Change (g)
The test substance was tested for skin sensitisation properties on mice using the local lymph node assay (Pooles, 2009). The study was conducted according to OECD 429 with the following test concentrations: 25%, 50% or 100% v/v in acetone/olive oil (4:1). A preliminary screening test suggested that the undiluted test substance would not produce systemic toxicity or excessive local irritation. The mice were treated by topical application of the appropriate test concentrations to the dorsal surface of each ear for 3 consecutive days. 5 days following the first application of the test substance, all mice were injected with ³H-methyl thymidine (³HTdR) and sacrificed 5 h afterwards. The draining auricular lymph nodes were excised and pooled for each experimental group. ³HTdR incorporation in lymphocytes was measured by beta-scintillation counting. There were no deaths during the study period and no signs of toxicity or local skin irritation were noted.
The mean stimulation index values were 22.52, 25.71 and 23.11 at treatment concentrations of 25, 50 and 100%, respectively.
Under the test conditions, the test substance was considered to be a skin sensitiser. No EC3 value was established, since no conventional dose-response relationship was observed. Since all SI values were greater than 3, the substance was considered to be a skin sensitiser.
With respect to the positive result of the local lymph node assay, it should be noted that there are certain limitations of the LLNA for surfactant type chemicals. Based on the physicochemical properties (surface tension), PEMB is not considered as a surface-active substance but it is a borderline case and could cause a false-positive result in the LLNA.
The available data on skin sensitisation meets the criteria for classification according to Regulation (EC) 1272/2008, and is therefore classified as skin sensitiser Category 1B (H317).
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