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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

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

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
after 60 minutes
Value:
25.9
Negative controls validity:
valid
Positive controls validity:
valid
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.