2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, phosphate

Endpoint summary

Description of key information

The test material is corrosive to the skin.  Based on the skin irritation results, the test material is considered to be corrosive to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

no

GLP compliance:

yes

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

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.

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)

Irritant / corrosive response data:

See Table 1.

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.

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 EpiDerm^TMreconstituted 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.

 

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The test material is corrosive to the skin. Based on the skin irritation results, the test material is considered to be corrosive to the eye.

Justification for selection of eye irritation endpoint:
No test conducted. Results based on skin corrosion test

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive