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EC number: 939-516-4
CAS number: -
In vitro eye and dermal studies on polyglycerine have been conducted.
The relative mean tissue viability for the positive control treated
tissues was 8.3% relative to the negative control treated tissues and
the standard deviation value of the percentage viability was 2.3%. The
positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was
0.744 and the standard deviation value of the percentage viability was
11.6%. The negative control acceptance criterion was therefore satisfied.
The standard deviation calculated from individual percentage tissue
viabilities of the three identically treated tissues was 3.1 %. The test
item acceptance criterion was therefore satisfied.
DETERMINATION OF SKIN IRRITATION POTENTIAL USING THE EPISKIN™
HUMAN EPIDERMIS MODEL
Mean OD540 Values and Percentage Viabilities for Control
Item, Positive Control Item and Test Item
Corrected viability of treated killed tissues = 0.130 (tkt) - 0.084
(ukt) = 0.046
* = The mean viability of the negative control tissues is set at 100%
OD540 = optical density
SD = Standard deviation
tvt = treated viable tissues
tkt = treated killed tissues
ukt = untreated killed tissues
Introduction: The purpose of this test was to evaluate the skin
irritation potential of the test item using the EPISKIN™ reconstructed
human epidermis model after a treatment period of 15 minutes followed by a
post-exposure incubation period of 42 hours. The principle of the assay
was based on the measurement of cytotoxicity in reconstructed human
epidermal cultures following topical exposure to the test item by means
of the colourimetric MTT reduction assay. Cell viability is measured by
enzymatic reduction of
the yellow MTT tetrazolium salt
(3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue
formazan salt (within the mitochondria of viable cells) in the test item
treated tissues relative to the negative controls. The concentration of
the inflammatory mediator IL-1α in the culture medium retained following
the 42-Hour post-exposure incubation period is also determined for test
items which are found to be borderline non-irritant based upon the MTT
reduction endpoint. This complimentary end-point will
be used to either confirm a non-irritant result or will be used to
override the non-irritant result. This method was designed to be
compatible with the following:
• OECD Guidelines for the Testing of Chemicals No. 439 "In Vitro Skin
Irritation" (adopted 22 July 2010)
• Method B.46 of Commission Regulation (EC) No. 440/2008/EC
Method: Triplicate tissues were treated with the test item for an
exposure period of 15 minutes. At the end of the exposure period each
tissue was rinsed before incubating for 42 hours. At the end of the
postexposure incubation period each tissue was taken for MTT-Ioading.
The maintenance medium from beneath each tissue was transferred to
pre-labelled micro tubes and stored in a freezer for possible inflammatory
mediator determination. After MTT loading a total biopsy of each
epidermis was made and placed into micro tubes containing acidified
isopropanol for extraction of formazan crystals out of the MTT -loaded
At the end of the formazan extraction period each tube was mixed
thoroughly and duplicate 200 μl samples were transferred to the
appropriate wells of a pre-labelled 96-well plate. The optical density
was measured at 540 nm.
Data are presented in the form of percentage viability (MTT reduction in
the test item treated tissues relative to negative control tissues).
Results: The relative mean viability of the test item treated tissues
was 95.0% after the 15-Minute exposure period.
Quality criteria: The quality criteria required for acceptance of
results in the test were satisfied.
Conclusion: The test item was considered to be Non-Irritant (NI).
Table 2 Assessment of Eye Irritation Potential - Viability of HCE Tissues
* = The mean viability of the negative control tissues is set at 100%.
Introduction. The purpose of this study was to determine the eye
irritation potential of the test item using the SkinEthic reconstructed
Human Corneal Epithelium model (HCE, SkinEthic Laboratories, Lyon,
France) after a treatment period of 10 minutes. The test is based on the
hypothesis that irritant chemicals are able to penetrate the corneal
epithelial tissue and are sufficiently cytotoxic to cause cell death.
Methods. The experimental design of the study consists of a test for
direct reduction of MTT (3 -[4,5 -dimethylthiazol-2 -yl]-2,5
-diphenyl-tetrazolium bromide) by the test item followed by the main
For the main test, triplicate SkinEthic tissues were treated with 30 ul
of the test item for 10 minutes. Triplicate tissues treated with 30 ul
of Solution A served as the negative control and triplicate tissues
treated with 30 ul of 2% w/v Sodium Dodecyl Sulphate (SDS) served as the
At the end of the exposure period each SkinEthic tissue was rinsed. The
rinsed tissues (two per group) were taken for MTT loading. The remaining
tissues were retained for possible histopathology. Following MTT loading
the reduced MTT was extracted from the tissues.
After extraction the absorbency of triplicate aliquots of the extracted
MTT solution for each SkinEthic tissue was measured. The optical density
was measured at 540 nm (OD540). Date are presented in the
form of percentage viability (MTT conversion relative to negative
The test item was classified according to the following criteria:
i) If the percentage relative mean tissue viability was >60%
the test item was considered to be non-irritant (NI).
ii) If the percentage relative mean tissue viability was <60% the test
item was considered to be an irritant (I).
Results. The relative mean viability of the test item treated tissues
after a 10 -Minute exposure period was 7.9%.
It was considered unnecessary to proceed with tissue histopathology.
Quality criterion. The quality criterion required for acceptance of
results in the test was satisfied.
Conclusion. According to the study plan followed the test item was
considered to be an Irritant (I).
There are no in vivo dermal or eye irritation
studies on polyglycerine. In vitro studies have been conductedaccording
to REACh requirements to decease animal testing and using validated in
vitro methods to estimate hazards.. In
an Episkin study with 2% caustic, polyglycerine was not corrosive to the
skin nor was it found to be an irritant. Similarly, the test material
was considered not to be an ocular corrosive or severe irritant in the
Bovine Corneal Opacity and Permeability (BCOP) assay. However in the
Human Corneal Epithelium (HCE) assay, the material was found to be an
irritant. Given that up to 2% NaOH may be present in the test material,
the material is considered to be moderately irritating to the eye or
skin. Thus based on the HCE assay results and the presence of up to 2%
NaOH possible in the test material,
this material is considered a Cat 2 for the eye.
There is no justification for classification on skin based on data from
For eye, given the in vitro test results, polyglycerine is a Cat 2.
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