N-Cocoyl L-Proline

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

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

In vitro test system

Test system:

human skin model

Cell type:

non-transformed keratinocytes

Vehicle:

not specified

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

50 µL of test substance neat

Duration of treatment / exposure:

The test item, the negative and positive control have been applied in duplicate on the tissues for 3 minutes at room temperature and 60 minutes at 37±1°C, 5±1 %CO2. To respect the exposure times the applications have been performed at intervals of not less than 1 minute.

Number of replicates:

2

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

after 60 minutes

Value:

25.9

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

after 3 minutes

Value:

33.99

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

On the basis of the results, interpreted according to OECD 431:2016, the test items “COCOYL PROLINE CAS 960241-19-4” must be considered CORROSIVE, a combination of sub-categories 1B-and-1C to skin.