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EC number: 939-505-4
CAS number: -
There were no deaths. No signs of
systemic toxicity were noted in the test or control animals during the
Bodyweight changes of the test animals
between Day I and Day 6 were comparable to those observed in the
corresponding control group animals over the same period, except for one
vehicle control animal which showed a greater than expected bodyweight
A Local Lymph Node Assay (LLNA) was performed to assess the skin
sensitisation potential of Phosflex 71B 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 OECD Guideline No.
429 (24 April 2002) and Method B42 of EC Regulation No. 440/2008.
Following a preliminary screening test in which no clinical signs of
toxicity were noted at a concentration of 100%, this concentration was
selected as the highest dose investigated in the main test of the LLNA.
Three groups, each of 5 animals, were treated with 50 ul (25 ul per ear)
of the undiluted test material or the test material as a solution in
acetone/olive oil 4:1 at concentrations of 50% or 25% v/v. A further
group of 5 animals was treated with acetone/olive oil 4:1 alone. A
concurrent positive control test, using a group of 5 animals, was also
performed with the known sensitiser, α -Hexylcinnamaldehyde tech., 85%,
at a concentration of 15% v/v in acetone/olive oil 4:1. Proliferative
capacity was determined by incorporation of 20 uCi 3H-methyl thymidine
per mouse and subsequent liquid scintillation counting. Mortality,
clinical signs and body weight were recorded. No mortality or clinical
signs were noted and body weights were within the range commonly
recorded for the test animals. The mean amount of disintegration per
minute (DPM) that were measured by liquid scintillation counting were:
8892.72, 10605.76, and 8587.76 for the concentrations of 25%, 50%, and
100%, respectively. Under the conditions of this study, Stimulation
Indices (SI), expressed as the mean radioactive incorporation for each
treatment group divided by the mean radioactive incorporation of the
vehicle control group, were as follows: 25% Phosflex 71B: 3.36; 50%
Phosflex 71B: 4.00; 100% Phosflex 71B: 3.24. α-Hexyicinnamaldehyde,
tech., 85% gave a SI of 5.62. Considering the SI threshold value of 3 as
stated in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC, Phosflex
71B needs to be classified as a sensitizer.
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