Reaction mass of nonane-1,3-diyl diacetate and tetrahydro-3-pentyl-2H-pyran-4-yl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydro-3-pentyl-2H-pyran-4-yl acetate

EC Number:

242-640-5

EC Name:

Tetrahydro-3-pentyl-2H-pyran-4-yl acetate

Cas Number:

18871-14-2

Molecular formula:

C12H22O3

IUPAC Name:

3-O-acetyl-1,5-anhydro-2,4-dideoxy-2-pentylpentitol

Constituent 2

Reference substance name:

Nonane-1,3-diyl diacetate

EC Number:

264-060-1

EC Name:

Nonane-1,3-diyl diacetate

Cas Number:

63270-14-4

Molecular formula:

C13H24O4

IUPAC Name:

nonane-1,3-diyl diacetate

impurity 1

Reference substance name:

1-(tetrahydrofuran-3-yl)hexyl acetate

Molecular formula:

C12H22O3

IUPAC Name:

1-(tetrahydrofuran-3-yl)hexyl acetate

impurity 2

Reference substance name:

rel-(3R,4R)-3-pentyltetrahydro-2H-pyran-4-ol

Cas Number:

24646-98-8

Molecular formula:

C10H20O2

IUPAC Name:

rel-(3R,4R)-3-pentyltetrahydro-2H-pyran-4-ol

impurity 3

Reference substance name:

3-hydroxynonyl acetate

Cas Number:

902270-36-4

Molecular formula:

C11H22O3

IUPAC Name:

3-hydroxynonyl acetate

Test material form:

liquid

Test animals / tissue source

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Bovine cattle eyes were obtained from freshly slaughtered cattle at the abattoir EVA.

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

As the test item is a non-surfactant-containing mixture, it will be tested undiluted (i.e. in its original form). Thus, no vehicle was used.

Controls:

yes

Amount / concentration applied:

750 μL (± 8 μL) for each cornea.

Duration of treatment / exposure:

10 minutes (± 30 seconds)

Duration of post- treatment incubation (in vitro):

Following the 10-minute treatment, the holders were incubated horizontally (corneas placed vertically) for 2 hours ± 10 minutes in a water bath at +32°C (± 1°C).

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

1

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

All acceptance criteria were fulfilled. The study was therefore considered as valid. The mean In Vitro Irritancy Score (IVIS) was: 1.

As the test item induced a mean IVIS ≤ 3, the test item was considered as a test chemical not requiring classification for eye irritation or serious eye damage (UN GHS No Category).

Under the experimental conditions of this study, the test item, Jasmonyl, was identified as a test chemical not requiring classification for eye irritation or serious eye damage (UN GHS No Category).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Jasmonyl does not require a classification for eye irritation or serious eye damage.

Executive summary:

Under the experimental conditions of this study, the test item, Jasmonyl, was identified as a test chemical not requiring classification for eye irritation or serious eye damage (UN GHS No Category).