Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
O-isopropyl ethylthiocarbamate
EC Number:
205-517-7
EC Name:
O-isopropyl ethylthiocarbamate
Cas Number:
141-98-0
Molecular formula:
C6H13NOS
IUPAC Name:
N-ethyl(propan-2-yloxy)carbothioamide
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): IPETC
- Physical state: Liquid
- Stability under test conditions: Stable
- Storage condition of test material:ambient

Test animals

Species:
other: Human Skin Model
Strain:
other: EST-1000 (CellSystems® Biotechnology GmbH)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
No test animals used, In-vitro test

ENVIRONMENTAL CONDITIONS
n/a

Test system

Type of coverage:
other: as specified in guidelines
Preparation of test site:
other: as specified in guidelines
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL IPETC were applied to the skin model with a surface area of 0.6 cm2
- Concentration (if solution): 95.7

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
Duration of treatment / exposure:
20 minutes
Observation period:
n/a
Number of animals:
n/a
Details on study design:
Negative control: phosphate buffered saline (D-PBS)
Positive control: 5% aqueous sodium dodecyl sulphate (SDS)

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: Percent Viability of cells exposed to test item
Value:
ca. 10.2
Remarks on result:
other:
Remarks:
Basis: mean Mean of 3 tissue sample responces in percent. Time point: 20 minutes. Max. score: 2.8. Reversibility: other: Not tested. Remarks: This is an in-vitro test with other irritation parameters than a traditional in-vivo test. (migrated information)

In vivo

Irritant / corrosive response data:
Summarized results (Mean±SD):

Optical density 20 minutes
Extinction# (n=3 tissues) % Extinction compared to control

Negative kontrol(D-PBS) 0.459±0.008
IPETC (test substance) 0.047±0.039 10.2
Positive kontrol(SDS) 0.014±0.007 3.1

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the present test conditions IPETC , tested at an exposure time of 20 minutes, was cytotoxic and, hence, irritant to skin in an experiment employing an artificial three-dimensional model of human skin.