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EC number: 700-990-0
CAS number: -
The initial key study was a mouse Local Lymph Node Assay. Under the
conditions of the study, Stimulation Indices (SI) of 3.36, 4.00, and
3.24 were calculated for 25%, 50%, and 100% Phosflex 71B, respectively.
Considering the SI threshold value of 3 as stated in Annex I of
1272/2008/EC and Annex VI of 67/548/EEC, the substance needs to be
classified as a sensitizer.
In the LLNA test performed with tBuTPP, the SI was >3 in all
concentrations tested, however, no dose-response relationship was
observed. The LLNA test is designed to study the induction phase of skin
sensitization and usually provides quantitative data suitable for
dose-response assessment. Furthermore, according to OECD guideline 429,
the decision process with regard to a positive response includes a
stimulation index ≥ 3, together with consideration of dose-response and,
where appropriate, statistical significance.
It is not clear why no dose-response was observed in the study with
tBuTPP. A cause may be that the substance has reached a maximum
saturation in the skin, which is supported by the expectation based on
the log Kow (4.68) that uptake into the stratum corneum will be high,
but the rate of penetration may be limited by the value of transfer
between the stratum corneum and the epidermis. Therefore, a new study
should be performed with lower concentrations to be able to calculate an
With the currently available information, no DNEL can be derived and the
risk of sensitization should be assessed using a qualitative approach.
To verify the potenttial sensitizig effects in humans, a Human Patch
test was performed. This test was initiated because there was a doubt
about the validity of the test in relation to humans, as no major
incidences have been recorded at the production site nor from downtream
users regarding sensitization. The substance is being produced over 40
years in US production facilities.
The result of the Patch test was clearly negative, and this result in
combination with the fact that there is no human epidemiological data
that shows that the substance causes sensitization, it was concluded
that it does not need to be classified for sensitization classification
of the substance under CLP.
Based on the outcome of the Humand Patch test in combination with worker
information from the production facility, it has been decided not to
classify the substance for sensitization.
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