Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

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:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
21-hydroxypregna-4,9(11),16-triene-3,20-dione 21-acetate
EC Number:
245-674-9
EC Name:
21-hydroxypregna-4,9(11),16-triene-3,20-dione 21-acetate
Cas Number:
23460-76-6
Molecular formula:
C23H28O4
IUPAC Name:
2-[(3aS,3bS,9aS,11aS)-9a,11a-dimethyl-7-oxo-3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate

In vitro test system

Test system:
human skin model
Remarks:
Episkin
Vehicle:
unchanged (no vehicle)
Control samples:
not specified
Amount/concentration applied:
not specified
Duration of treatment / exposure:
not specified
Duration of post-treatment incubation (if applicable):
not specified
Number of replicates:
not specified

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: not specified
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Dehydrocortinene was non irritant to the skin, in an Episkin test model.

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