Heptan-4-olide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

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

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dihydro-5-octylfuran-2(3H)-one

EC Number:

218-971-6

EC Name:

Dihydro-5-octylfuran-2(3H)-one

Cas Number:

2305-05-7

Molecular formula:

C12H22O2

IUPAC Name:

Dihydro-5-octylfuran-2(3H)-one

Test animals / tissue source

Species:

other: Bos primigenius Taurus (fresh bovine corneas)

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

The respective substance (negative control solution, test item or positive control) was ap-plied by pipetting 750 µL of the appropriate liquid through the refill hole in the holder on the cornea.

Duration of treatment / exposure:

Exposure time of the test item on the corneas was 10 minutes at 32 ± 1 °C.

Duration of post- treatment incubation (in vitro):

After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chamber was filled with cMEM without phenol red, and the corneas were stored for additional 2 hours at 32 ± 1 °C (post-incubation).

Number of animals or in vitro replicates:

3

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

Bovine Corneal Opacity and Permeability (BCOP) Test Method following OECD Guideline 437 and EU Method B.47

Value:

ca. 0.22

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item gamma-Dodecalactone showed no effects on the cornea of the bovine eye. The calculated IVIS is 0.22.