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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP/Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, phosphate
EC Number:
258-053-2
EC Name:
2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, phosphate
Cas Number:
52628-03-2
Molecular formula:
C6 H10 O3 . x H3 O4 P
IUPAC Name:
2-(methacryloyloxy)ethyl phosphate
Test material form:
other: semi-viscous liquid
Details on test material:
- Name of test material (as cited in study report): Reaction product of 2-Hydroxyethyl methacrylate (HEMA) with Polyphosphoric Acid (PPA)
- Physical state: clear very light yellow semi-viscous liquid
- Lot/batch No.: A022C73001
- Storage condition of test material: room temperature

Test animals

Species:
human
Details on test animals or test system and environmental conditions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The tissues exposed for 3 minutes were held at room temperature during dosing, while the tissues exposed for the 60 minutes were
incubated at standard culture conditions (37°) until the completion of the exposure time.

IN-LIFE DATES: From: To: 8/27/12 - 8/29/2012

Test system

Type of coverage:
not specified
Preparation of test site:
other: EpiDerm Skin Model
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Fifty µL of the test substance were applied directly on the tissue so as to cover the upper surface.
- Concentration (if solution): The test substance was tested neat.

Duration of treatment / exposure:
3 minutes and 60 minutes
Observation period:
End of exposure
Number of animals:
n/a
Details on study design:
The test substance was added to a 1.0 mg/mL MTT (Sigma) solution in warm Dulbecco’s Modified Eagle’s Medium (DMEM) containing 2 mM L-glutamine (MTT Addition Medium) to assess its ability to directly reduce MTT. Approximately 50 µL of the test substance were added to 1 mL of the MTT solution, and the mixture was incubated at standard culture conditions for approximately one hour. A negative control, 50 µL of sterile, deionized water (Quality Biological), was tested concurrently. If the MTT solution color turned blue/purple, the test substance was presumed to have reduced the MTT.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: cell viabiilty
Value:
ca. 23.9
Remarks on result:
other:
Remarks:
Basis: other: %. Time point: 3 minutes. (migrated information)
Irritation / corrosion parameter:
other: other: cell viability
Value:
ca. 1.4
Remarks on result:
other:
Remarks:
Basis: other: %. Time point: 60 minutes. (migrated information)

In vivo

Irritant / corrosive response data:
See Table 1.

Any other information on results incl. tables

Mean % Viability

 Concentration  Exposure Time  % Viability  * Corrosive?  pH
 Neat  3 minutes 23.9  Yes  4.0
 Neat  60 minutes  1.4  Yes  4.0

* - A material is considered corrosive if the percent viability is less than 50% at the 3 -minute exposure, or less than 15% at the 60 -minute exposure.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: UN GHS
Conclusions:
Based upon the results of this assay, the test substance, Reaction product of 2-Hydroxyethyl methacrylate (HEMA) with Polyphosphoric Acid (PPA), was predicted to be corrosive to skin according to the prediction model validated by ECVAM. Accordingly, the test substance, Reaction product of 2-Hydroxyethyl methacrylate (HEMA) with Polyphosphoric Acid (PPA), would be labeled corrosive to skin within the Globally Harmonized System.
Executive summary:

The MatTek Corporation’s EpiDermTMreconstituted human epidermis model was used to assess the potential skin corrosivity of the test substance, Reaction product of 2-Hydroxyethyl methacrylate (HEMA) with Polyphosphoric Acid (PPA).The skin corrosivity potential of the testsubstancewas evaluated by measuring the relative cell viability in treated tissues after a 3- and 60-minute exposure to the testsubstance, following theprotocol that is consistent with the OECD Test Guideline 431 “In Vitro Skin Corrosion: Human Skin Model Test”. Based upon the results of this study, the test substance, Reaction product of 2-Hydroxyethyl methacrylate (HEMA) with Polyphosphoric Acid (PPA), is predicted to be a skin corrosive. Accordingly, the test substance,Reaction product of 2-Hydroxyethyl methacrylate (HEMA) with Polyphosphoric Acid (PPA), would be labeled corrosive to skin within the Globally Harmonized System.