Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 483-360-5
CAS number: 114435-02-8
An in vitro skin corrosion (equivalent to OECD 431) and skin irritation
assay (OECD 439) are available for the substance. For the eye irritation
endpoint an in vitro study is available (OECD 437) alongside
considerations for waiving further work. No studies are available to
assess respiratory irritation.
Table 1: OD540 Values and %
viabilities for the negative control, positive control and test material
Mean % Viability4
1.895 ± 0.100
1.824 ± 0.071
0.258 ± 0.056
13.6 ± 3.0
0.118 ± 0.002
6.5 ± 0.1
1.583 ± 0.025
83.6 ± 1.3
1.205 ± 0.087
66.1 ± 4.7
= OD540 representing each EpiDerm tissue
= Mean OD540 of duplicate EpiDerm tissues ± standard deviation
= Viability representing each EpiDerm tissue expressed as a percentage
of the mean OD540 of either the 3 minute or 60 minute negative control
= Mean viability of duplicate treated EpiDerm tissues ± standard
= Mean viability of negative control tissues set at 100%
The study was performed to assess the
corrosivity potential of the test material using the EpiDerm Skin Model
(MatTek, Ashland, MA, USA). The test is based on the hypothesis that
corrosivity potential is related to toxicity to the EpiDerm tissue. The
study was validated by the inclusion of a positive control material, 8.0
N Potassium Hydroxide.
The experimental design of the study
consists of a test for Direct Reduction of MTT by the test material,
followed by the main test.
For the main test, duplicate EpiDerm tissues
were treated with 50 μL of Monofluoroethylene carbonate and exposed for
3 minutes and 60 minutes. The tissues were incubated at 37°C in a
humidified atmosphere of 5% C02 in air for the appropriate exposure
Duplicate negative and positive control
tissues, treated with 50 μL sterile distilled water or 50 μL 8.0 N
Potassium Hydroxide respectively, were also exposed for 3 minutes and 60
At the end of the exposure period each
EpiDerm tissue was rinsed using Dulbecco' s phosphate buffered saline
(DPBS) and placed into a 'holding plate', until all of the tissues had
been treated and rinsed. They were then transferred to an MTT 'loading
plate', and incubated at 37°C for 3 hours in a humidified atmosphere of
5% C02 in air. At the end of this time, each EpiDerm tissue was blotted
dry and placed into an MTT 'extraction plate' in order to extract all of
the reduced MTT from the tissues.
At the end of the extraction period, the
extracted MTT solution was mixed for each EpiDerm tissue and 3 x 200 μL
samples for each tissue were transferred to the appropriate wells of a
96 well plate. The absorbency at 540nm (OD540) of each well was measured
with the Anthos 2001 microplate reader. Data are presented in the form
of % viability (MTT conversion relative to negative controls) for each
of the two exposure times.
The relative mean viability of
Monofluoroethylene carbonate treated tissues was 83 .6% after 3 minutes
exposure and 66.1 % after 60 minutes exposure.
The quality criteria required for acceptance
of results in the test were satisfied.
Monofluoroethylene carbonate was considered
to be non-corrosive in vivo.
Table 1: Individual OD values mean OD and individual tissue viability
Individual tissue viability
(% of control)
For the skin irritation endpoint, the in vitro corrosion assay provided
a negative result indicating that the test substance would not be
considered corrosive. However, the in vitro skin irritation assay
provided a positive result indicating the substance has skin irritation
potential. As such the substance is regarded as a skin irritant category
2 (H315) in accordance with the CLP Regulation (EC No. 1272/2008, as
With regards to eye irritation an in vitro BCOP assay is available which
provided an inconclusive result and accordingly cannot be used for
classification purposes. In accordance with Column 2 Annex VII of REACH:
"the substance is classified as skin irritation and the available
information indicates that it should be classified as eye irritation
This substance was originally submitted and notified under the Dangerous
Substances Directive (67/548/EEC) and was classified for skin and eye
irritation under that Directive by the orginal data holder. These
classifications have since been upgraded to GHS as H315 (Causes skin
irritation) and H319 (Causes serious eye irritation) and had been so
notified to the ECHA C & L inventory. The original data owners were
unwilling to take on the duties of REACH Lead Registrant and we have
therefore purchased access to their original data for use in this
registration. Since the data is the same we feel that it is important
to maintain the same classifications agreed with the relevant National
Competent Authorities for the original DSD notifications. We have
therefore kept the classification as H315 and H319 and further testing
on these endpoints is not warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Deze website maakt gebruik van cookies om het surfen zo aangenaam mogelijk te maken.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again