(2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

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)

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate)

Cas Number:

2233585-18-5

Molecular formula:

C39H46N2O12

IUPAC Name:

(2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate)

Test material form:

solid

Remarks:

Light yellow solid (powder)

Test animals / tissue source

Species:

cattle

Strain:

other: slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany

Details on test animals or tissues and environmental conditions:

The cattle were between 12 and 60 months old. The eyes were transported to the test fa-cility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicil-lin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour and 15 minutes.

Test system

Vehicle:

not specified

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

750 µL

Duration of treatment / exposure:

4 hours at 32 ± 1 °C

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

ca. 1.03

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.
Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative con-trol showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Irri-tancy Score) was 1.30.
20% imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current histori-cal mean. The calculated mean IVIS was 88.98.
Under the conditions of this study, the test item Chiguard GA403 showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 1.03.

Any other information on results incl. tables

Classification Scheme

IVIS	UN GHS
≤ 3	No category
> 3 and≤ 55	No prediction can be made
> 55	Eye damage Category I

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this test, the test item Chiguard GA403 showed no effects on the cornea of the bovine eye. The calculated mean IVIS was 1.03.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 re-quires no classification for eye irritation or serious eye damage.