Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 30, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethanol, propoxylated

EC Number:

500-041-9

EC Name:

Propylidynetrimethanol, propoxylated

Cas Number:

25723-16-4

Molecular formula:

C9 H20 O4

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol

Constituent 2

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono-2-propenoate

Cas Number:

1378240-17-5

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC9H16O4

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono-2-propenoate

Constituent 3

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), di-2-propenoate

Cas Number:

104956-81-2

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC12H18O5

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), di-2-propenoate

Constituent 4

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono[3-[(1-oxo-2-propen-1-yl)oxy]propanoate] mono-2-propenoate

Cas Number:

1378240-19-7

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC12H18O5 + C3H4O2

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono[3-[(1-oxo-2-propen-1-yl)oxy]propanoate] mono-2-propenoate

Constituent 5

Reference substance name:

Propylidynetrimethanol, propoxylated, esters with acrylic acid

EC Number:

500-123-4

EC Name:

Propylidynetrimethanol, propoxylated, esters with acrylic acid

Cas Number:

53879-54-2

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC15H20O6

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-[(1-oxo-2-propenyl)oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol

Constituent 6

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono[3-[(1-oxo-2-propen-1-yl)oxy]propanoate] di-2-propenoate

Cas Number:

1378240-20-0

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC15H20O6 + C3H4O2

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono[3-[(1-oxo-2-propen-1-yl)oxy]propanoate] di-2-propenoate

Constituent 7

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, ester ether with 3-hydroxypropanoic acid (6:2:1), [3-[(1-oxo-2-propen-1-yl)oxy]propanoate] tri-2-propenoate

Cas Number:

1378240-22-2

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC12H18O5 + (C3H6O)n(C3H6O)n(C3H6O)nC15H20O6

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, ester ether with 3-hydroxypropanoic acid (6:2:1), [3-[(1-oxo-2-propen-1-yl)oxy]propanoate] tri-2-propenoate

Constituent 8

Reference substance name:

Michaël adduct of propoxylated trimethylolpropane monoacrylate (TMP(PO)MA) with propoxylated trimethylolpropane triacrylate (TMP(PO)TA) and propoxylated trimethylolpropane monoacrylate (TMP(PO)MA)

Molecular formula:

Not available (UVCB substance)

IUPAC Name:

Michaël adduct of propoxylated trimethylolpropane monoacrylate (TMP(PO)MA) with propoxylated trimethylolpropane triacrylate (TMP(PO)TA) and propoxylated trimethylolpropane monoacrylate (TMP(PO)MA)

Constituent 9

Reference substance name:

Sum of other constituents

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Sum of other constituents

Test material form:

liquid

Test animals / tissue source

Species:

cattle

Strain:

other: Bos primigenius Taurus

Details on test animals or tissues and environmental conditions:

Bovine corneas were used. They were collected from slaughtered cattle (from Müller Fleisch GmbH, Enz str. 2-4, 75217 Birkenfeld, Germany, on the day of the test) which were between 12 and 60 months old.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

750 µL (the “closed chamber-method” was used in this study, for liquid substances)

Duration of treatment / exposure:

10 min at 32 ± 1 °C

Duration of post- treatment incubation (in vitro):

42h

Number of animals or in vitro replicates:

3

Details on study design:

The test substance was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 h and whose opacity had been measured. The test substance was incubated on the cornea for 10 min at 32 ± 1 °C. After removal of the test substance and 2 h post-in cubation, opacity and permeability values were measured.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

cornea opacity and permeability

Value:

-0.62

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

HBSS solution was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (in vitro irritancy score) was 1.46. Undiluted dimethylformamide (DMF) was used as positive control. The positive control induced serious eye damage on the cornea resulting in a calculated IVIS of 92.06. The values for both the negative and positive control fall within the historical control data. The test substance showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is -0.62.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage. Therefore, under the conditions of this study, the test substance, doesn’t need to be classified for eye irritation in accordanceto CLP (EC N° 1272/2008).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the test substance was not found to be irritating to bovine eye (BCOP test).

Executive summary:

A study was conducted to determine the in vitro eye irritation potential of the test substance according to OECD Guideline 437 and EU Method B.47 (BCOP test), in compliance with GLP. Bovine eyes were exposed to 750 µL undiluted test substance for 10 min (in triplicates). After removal of the test substance and 2 h post-incubation, opacity and permeability values were measured and reported as the in vitro irritancy score (IVIS). HBSS was used as negative control and dimethylformamide (DMF) undiluted as positive control. HBSS showed no irritating effect on the cornea and the calculated IVIS was 1.46. DMF induced serious eye damage on the cornea and fell within two standard deviations of the current historical mean. The calculated IVIS was 92.6. The test substance showed no effects on the cornea of the bovine eye. The calculated IVIS was -0.62. All validity criteria were met. Based on IVIS score of <3, the test substance was considered to be not irritating to bovine eye (Andres, 2016).