Registration Dossier
Registration Dossier
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EC number: 205-517-7 | CAS number: 141-98-0
Skin irritation / corrosion
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:
- 2 012
- 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
- 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
Constituent 1
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.
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