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EC number: 232-056-9
CAS number: 7784-30-7
One key study is available (Bradshaw J (2012) for the skin sensitisation
endpoint. The study reports that aluminium orthophosphate is a
non-sensitiser under the conditions of the study.
bodyweight and mortality data are given in Table 2 and
local skin irritation is given in Table 3. The ear
thickness measurements and mean ear thickness changes
are given in Table 4.
No signs of systemic
toxicity, visual local skin irritation or irritation
indicated by an equal to or greater than 25% increase in
mean ear thickness were noted.
Based on this information
the dose levels selected for the main test were 25%, 10%
and 5% w/w in propylene glycol.
disintegrations per minute per lymph node and the
stimulation index are given in Table 5.
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 (Table 1):
Concentration (%w/w) inpropylene glycol
observations and mortality data for test and control
animals are given in Table 5.
There were no deaths. No
signs of systemic toxicity were noted in the test or
control animals during the test.
Individual bodyweights and
bodyweight changes for test and control animals are
given in Table 6.
Bodyweight changes of the
test animals between Day 1 and Day 6 were comparable to
those observed in the corresponding control group
animals over the same period.
2 Clinical Observations, Bodyweight and
Mortality Data – Preliminary Screening Test
signs of systemic toxicity
Table 3. Local skin
irritation - preliminary screening test
Local skin irritation
Table 4. Measurement
of Ear Thickness and Mean Ear Thickness Changes –
Preliminary Screening Test
(% w/w) in
Ear thickness measurement (mm)
Overall mean (mm)
Overall mean ear thickness change (%)
Table 5. Disintegrations per
Minute, Disintegrations per Minute/Node and Stimulation
Concentration(%w/w) inpropylene glycol
dpm = Disintegrations
a = Disintegrations
per minute/node obtained by dividing the disintegrations
per minute value by 8
(total number of lymph
b = Stimulation Index
of 3.0 or greater indicates a positive result
na = Not applicable
Table 6. Individual
Clinical Observations and Mortality Data
Concentration(% w/w) inpropylene glycol
Bodyweights and Bodyweight Changes
Bodyweight Change (g)
see attachment "Appendix
1 Current Positive Control Study for the Local Lymph
see attachment "Appendix
2 Summary of Positive Control Data for the Local
Lymph Node Assay”
A study was performed to assess the skin sensitisation potential of the
test item in the CBA/Ca strain mouse following topical application to
the dorsal surface of the ear. The method was designed to be compatible
with the following:
OECD Guideline for the Testing of Chemicals No. 429 "Skin
Sensitisation: Local Lymph Node Assay" (adopted 22 July 2010)
Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission
Regulation (EC) No. 440/2008
Following a preliminary screening test in which no clinical signs of
toxicity were noted at a concentration of 25% w/w, 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 test item as a suspension in propylene
glycol at concentrations of 25%, 10% or 5% w/w. A further group of four
animals was treated with propylene glycol alone.
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:
The test item was considered to be a non-sensitiser under the conditions
of the test. The test item does not meet the criteria for classification
according to the Regulation (EC) No 1272/2008, relating to the
Classification, Labelling and Packaging of Substances and Mixtures.
This study is considered to be a reliability 1 study (according to the
Klimisch scale) as it has been conducted to the appropriate guideline
(OECD 249, Local Lymph Node Assay) and under the conditions of GLP.
Therefore, this study is considered to be appropriate for use as a key
No data available. There is no information to suggest that aluminium
orthophosphate is a respiratory sensitiser.
accordance with Regulation (EC) No.1272/2008 (EU CLP) classification is
not proposed based on the results of the key study. As the key study has
been conducted according to the appropriate guidelines and under the
conditions of GLP further in vivo testing is deemed to be scientifically
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