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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08/08/2016 - 24/08/2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to guideline
Guideline:
other: Reg (EC) No 1907/ 2006 of the EU Parliament and of the Council of 18 Dec 2006
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
EC Number:
213-563-4
EC Name:
9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
Cas Number:
981-34-0
Molecular formula:
C22H28O5
IUPAC Name:
17,21-dihydroxy-16-methyl-9,11-epoxypregna-1,4-diene-3,20-dione
Test material form:
solid: particulate/powder

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: multilayered highly differentiated epidermis model
Source strain:
other: human
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL
Duration of treatment / exposure:
3 days
Duration of post-treatment incubation (if applicable):
After rinsing the units were placed into the plate wells with fresh assay medium (0.9 mL/well) and dried with the sterile cotton swab, then the plates were incubated for 24 hours (± 2) at 37 °C in an incubator with 5 % CO2, 95 % RH.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: no alert
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Test item showed no reduced cell viability in comparison to the negative control. The mean viability of test item’s three replicates results was 123.4 % of the mean negative control value.
Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.
In this in vitro skin Irritation test with the EpiDermTM model on the test item BETAMETHYLEPOXY, results indicated that the test item is Non Irritant [GHS: No Category].

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