N-Cocoyl L-Proline

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-(1-oxododecyl)-L-proline

Cas Number:

58725-39-6

Molecular formula:

C17H31NO3

IUPAC Name:

1-(1-oxododecyl)-L-proline

Constituent 2

Reference substance name:

1-(1-oxotetradecyl)-L-Proline

Cas Number:

86282-96-4

Molecular formula:

C19H35NO3

IUPAC Name:

1-(1-oxotetradecyl)-L-Proline

Constituent 3

Reference substance name:

1-(1-oxodecyl)-L-Proline

Cas Number:

86282-95-3

Molecular formula:

C15H27NO3

IUPAC Name:

1-(1-oxodecyl)-L-Proline

Constituent 4

Reference substance name:

1-(1-oxooctyl)-L-Proline

Cas Number:

86282-94-2

Molecular formula:

C13H23NO3

IUPAC Name:

1-(1-oxooctyl)-L-Proline

Constituent 5

Reference substance name:

1(1-oxohexadecyl)-L-proline

Cas Number:

59441-32-6

Molecular formula:

C21H39NO3

IUPAC Name:

1(1-oxohexadecyl)-L-proline

Constituent 6

Reference substance name:

Dodecanoylprolyl-Lproline

IUPAC Name:

Dodecanoylprolyl-Lproline

Constituent 7

Reference substance name:

Tetradecanoylprolyl-L-proline

IUPAC Name:

Tetradecanoylprolyl-L-proline

Constituent 8

Reference substance name:

Palmitoylprolyl-L-proline

IUPAC Name:

Palmitoylprolyl-L-proline

Constituent 9

Reference substance name:

1-(1-oxooctadecyl)-L-proline

Molecular formula:

C23H43NO3

IUPAC Name:

1-(1-oxooctadecyl)-L-proline

Constituent 10

Reference substance name:

potassium;chloride

Cas Number:

7447-40-7

Molecular formula:

KCl

IUPAC Name:

potassium;chloride

Constituent 11

Reference substance name:

Reference substance 001

Cas Number:

1310-58-3

Molecular formula:

KOH

Constituent 12

Reference substance name:

Tripotassium phosphate

Cas Number:

7778-53-2

IUPAC Name:

Tripotassium phosphate

impurity 1

Reference substance name:

Unknown impurities

IUPAC Name:

Unknown impurities

Test animals / tissue source

Species:

cattle

Test system

Vehicle:

water

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

Application of volume of 750 µL of 20% w/v test item (in water)

Duration of treatment / exposure:

3 hours and 55 minutes

Duration of post- treatment incubation (in vitro):

Post incubation of 85 minutes

Number of animals or in vitro replicates:

three in vitro replicates

Details on study design:

A volume of 750 µL of 20% w/v test item,vehicle (distilled water) and positive control (20% w/v imidazole)was introduced into anterior chamber in triplicates to the designated cornea holders and incubated at 32±1 ºC for 3 hours and 55 minutes. Treated corneas were washed till no visual evidence of test item observed with EMEM containing phenol red and finally with EMEM without phenol red. The anterior chamber was then refilled with fresh EMEM without phenol red. Opacity was measured with the aid of opacitometer and permeability was determined spectrophotometrically at 490 nm (OD490) using 5 mg/mL sodium fluorescein, post incubation of 85 minutes at 32±1 ºC.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

38.6

Vehicle controls validity:

valid

Remarks:

The vehicle control and test item resulted in mean change in opacity value after treatment of 2.584 and 18.241 respectively. The mean corrected opacity and mean corrected permeability values of test item are 15.66 and 1.532 respectively.

Positive controls validity:

valid

Remarks:

Positive control resulted in mean change in opacity of 86.93. The mean corrected opacity and mean corrected permeability values of positive control are 84.33 and 1.549 respectively with an in vitro Irritancy Score (IVIS) of 107.6.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Based on the results obtained in the Bovine Corneal Opacity and Permeability Test, the test item Cocoyl proline CAS: 960241-19-4 induced an IVIS of 38.6 after 3 hours and 55 minutes of treatment. As the test item induced an IVIS > 3 and ≤ 55, the results are equivocal and no prediction can be made regarding the corrosivity or severe irritancy to Bovine corneas.