9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Test guideline 2

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

Test material information

Constituent 1

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].