Registration Dossier
Registration Dossier
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EC number: 216-652-6 | CAS number: 1634-02-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrabutylthioperoxydicarbamic acid
- EC Number:
- 216-652-6
- EC Name:
- Tetrabutylthioperoxydicarbamic acid
- Cas Number:
- 1634-02-2
- Molecular formula:
- C18H36N2S4
- IUPAC Name:
- tetrabutylthioperoxydicarbamic acid
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 uL applied in triplicate of each of the test solution, positive control and negative control
- Duration of treatment / exposure:
- 7minutes contact time then kept at room temperature for 15minutes.
- Duration of post-treatment incubation (if applicable):
- Each tissue was rinsed with water and transferred into wells containg 2mL of maintenance medium and incubated for 42 hours.
- Number of replicates:
- Samples tests in triplicate.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Optical Density (OD570) at 570mm
- Value:
- ca. 0.888
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- OD750 = 0.862
- Positive controls validity:
- valid
- Remarks:
- OD750 = 0.241
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Results from Skin irritancy study indicate that TBUT showed no skin irritation effects.
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