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EC number: 233-190-0
CAS number: 10058-44-3
Skin irritation: In accordance with the testing strategy detailed in Annex VIII, column 1 of Regulation (EC) No. 1907/2006 the assessment of the endpoint ‘skin irritation or skin corrosion’ has been performed following the consecutive steps detailed in the Regulation. As such an in vitro skin corrosion study has been performed. This study is not considered as the key study because it is not sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP) and is therefore submitted as supporting data. The key study (Warren N, 2012) is conducted according to an appropriate validated in vitro guideline and under the conditions of GLP and therefore the study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint. In addition, the data is considered to be adequate and reliable for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). Eye irritation: In accordance with the testing strategy detailed in Annex VIII, column 1 of Regulation (EC) No. 1907/2006 an ex vivo study has been performed prior to conducting an in vivo study. This study is not considered as the key study because it is not sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). However, the study does support the conclusion that tetrairon tris(pyrophosphate) is not corrosive to the eyes and the data can therefore be used to support the conclusions made in the key study. The key study (Bradshaw J, 2012) is conducted according to an appropriate guideline and under the conditions of GLP and therefore the study is considered to be acceptable and to adequately satisfy the regulatory requirement as a key study for this endpoint.
MTT solution containing the test material did not turn blue/purple which
indicated that the test material did not directly reduce MTT.
individual and mean OD540 values, standard deviations and
tissue viabilities for the test material, negative control material and
positive control material are given in Table 1. The mean viabilities and
standard deviations of the test material and positive control, relative
to the negative control are also given in Table 1.
relative mean viability of the test material treated tissues was 100.0%
after a 15 minute exposure.
The MTT solution containing the test item
did not turn blue which indicated that the test item did not directly
The relative mean tissue viability for the
positive control treated tissues was 8.6% relative to the negative
control treated tissues and the standard deviation value of the
percentage viability was 1.0%. The positive control acceptance
criterion was therefore satisfied.
The mean OD540 for the negative control
treated tissues was 0.659 and the standard deviation value of the
percentage viability was 6.2%. The negative control acceptance criterion
was therefore satisfied.
The standard deviation calculated from
individual percentage tissue viabilities of the three identically
treated tissues was 10.5%. The test item acceptance criterion was therefore
Mean OD540of triplicate tissues
Relative individual tissue viability (%)
Relative mean viability (%)
± SD of Relative mean viability (%)
Negative Control Material¤
Positive Control Material¤
*= The mean viability of the
negative control tissues is set at 100%
= Control group shared with Harlan Laboratories Ltd, Project
numbers 41200853, 41200860, 41200861, 41200866, 41200871, 41200880 and
numerical values corresponding to each animal, tissue and observation
time were recorded. The data relating to the conjunctivae were
designated by the letters A (redness), B (chemosis) and C (discharge),
those relating to the iris designated by the letter D and those
relating to the cornea by the letters E (degree of opacity) and F
(area of cornea involved). For each tissue the score was calculated as
for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
the numerical data obtained a modified version of the system (
Modified Kay and Calandra Interpretation of Eye Irritation Test was
used to classify the ocular irritancy potential of the test
material. This was achieved by adding together the scores for the
cornea, iris and conjunctivae for each time point for each rabbit. The
group means of the total scores for each observation were
calculated. The highest of these group means (the maximum group mean
score) together with the persistence of the reactions enabled
classification of the eye irritancy potential of the test material.
evidence of irreversible ocular damage is noted, the test
material will be classified as corrosive to the eye.
and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex
IPR = 2
Time After Treatment
E = Degree of Opacity
F = Area of Cornea Involved
Score (E x F) x 5
Score (D x 5)
A = Redness
B = Chemosis
C = Discharge
Score (A + B + C) x 2
2 Individual Total Scores and Group Mean Scores
for Ocular Irritation
Individual Total Scores At:
Group Mean Score
classification is proposed for skin or eye irritancy of tetrairon
tris(pyrophosphate) in accordance with Regulation (EC) No. 1272/2008 (EU
CLP). This conclusion is based on reliable (Klimisch 1) studies and
adequate data and as such no further testing is anticipated.
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