Reaction products of methacrylic acid and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-03-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 437

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

not signed

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-3-{4-[2-(4-{2-hydroxy-3-[(2-methylprop-2-enoyl)oxy]propoxy}phenyl)propan-2-yl]phenoxy}propyl 2-methylprop-2-enoate

EC Number:

701-308-4

Cas Number:

36425-15-7

Molecular formula:

n/a

IUPAC Name:

2-hydroxy-3-{4-[2-(4-{2-hydroxy-3-[(2-methylprop-2-enoyl)oxy]propoxy}phenyl)propan-2-yl]phenoxy}propyl 2-methylprop-2-enoate

Details on test material:

Approximately 80% BisGMA
13 % Polymeric methacrylates

Test animals / tissue source

Species:

other: Cow

Details on test animals or tissues and environmental conditions:

Eyes from cattles were used same days as they were slaughtered

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

1122 mg and 2484 mg

Duration of treatment / exposure:

Corneas were pre-incubated for 1 hour minimum at 32 C. Exposure time was 10 minutes. After exposure the cornea was rinsed to remove the test substance, and incubated for 2 hours for opacity measurement. The permeability was measured after 90 minutes incubation with sodium flourescein

Observation period (in vivo):

Corneas were incubated for 2 hours after exposure for opacity measurement, and 90 minutes for permeability testing

Number of animals or in vitro replicates:

3 eyes for negative, positive, positive on gauze pacth and the test substance, respectively.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Done after exposure time
- Time after start of exposure:

SCORING SYSTEM: Opacity was measured using an opacitometer (OP-KIT,MC2, Clermont, France)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Mean Opacity

Basis:

mean

Time point:

other: 2 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 2

Irritation parameter:

other: Mean Permeability

Basis:

mean

Time point:

other: 90 minutes

Score:

0.011

Max. score:

0.015

Irritant / corrosive response data:

The In Vitro Irritancy score (IVIS) were calculated to 0.2. According to OECD Guideline 437 a substance has to induce a IVIS more or equal to 55.1 in order to be defined as corrosive or severe irritant. The positive controls induced a IVIS at 147 and 134, respectively, where as the negative control induced a IVIS at 0.0, conclusively the tested substance was similar to the negative control.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Small Vinyl Ester was tested for eye irritating potential and permeability, following OECD Guideline 437. The substance obtained values similar to the negative control, thus Small Vinyl Ester is considered a non irritant.

Executive summary:

Small Vinyl Ester was tested for eye irritating potential and permeability, following OECD Guideline 437. Data for the negative and positive controls showed validity of the test system. Small Vinyl Ester obtained values for both Opacity and Permeability, similar to the negative control. The obtained In Vitro Irritancy Score (IVIS) was 0.2, whereas according to the OECD Guideline 437, a substance has to obtain a IVIS at 55.1 or more in order to be defined as a corrosive or irritant. In can therefore be concluded that Small Vinyl Ester is not an irritant when tested according to OECD Guideline 437.