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EC number: 700-341-1 | CAS number: 105194-34-1
Individual clinical observations and mortality data for test and control animals are given in Table 3.
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Red coloured staining on the ears was noted, post dose on Day 1 and on Days 2 to 6, in all test animals.
Clinical observations, bodyweight and mortality data are given in Table 1.
The radioactive disintegrations per minute per lymph node and the stimulation index are given in Table2.
Individual bodyweights and bodyweight changes for test and control animals are given in Table 4.
Table 1 Clinical Observations, Bodyweight and Mortality Data – Preliminary Screening Test
Concentration (%w/w) inethanol/distilled water 7:3
0= No signs of systemic toxicity
Fs = Red coloured staining on the ears
Table 2 Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration(%w/w) inethanol/distilled water 7:3
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(% w/w) inethanol/distilled water 7:3
Bodyweight Change (g)
A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:
§ OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted)
§ Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/73/EC
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100% v/v, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the undiluted test material or the test material as a solution in acetone/olive oil 4:1at concentrations of 50% or 25% v/v. A further group of four animals was treated with acetone/olive oil 4:1alone.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (%v/v) inacetone/olive oil 4:1
The test material was considered to be a non‑sensitiser under the conditions of the test.
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