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Toxicological information

Skin irritation / corrosion

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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:
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

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: EST-1000 (CellSystems® Biotechnology GmbH)

Test system

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:
% tissue viability
Value:
ca. 10.2
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Mean of tissue sample responses in percentage. Time point: 20 minutes. Reversibility not tested. Indication of a positive result.
Other effects / acceptance of results:
Summarized results (Mean±SD):

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

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

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Based on EU GHS criteria
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.
Executive summary:

An In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method was performed with the test substance in accordance with OECD Guideline 439 (employing an epidermal human Skin Test 1000 (EST-1000) cell tissue system). Under the test conditions, the test substance tested at an exposure time of 20 minutes, in an artificial three-dimensional model of human skin, was cytotoxic and, hence, irritant to skin in an experiment employing an artificial three-dimensional model of human skin.