Registration Dossier
Registration Dossier
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EC number: 922-363-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Sample submitted to INTOX PVT. LTD. , 375, Urawade, Tal. Mulshi, Dist. Pune, Maharashtra, 412115,
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 87 days
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2Z)-but-2-enedioic acid; N-[2-(dimethylamino)ethyl]-5-(1,2-dithiolan-3-yl)pentanamide
- EC Number:
- 922-363-2
- Cas Number:
- 865661-00-3
- Molecular formula:
- C16H28N2O5S2
- IUPAC Name:
- (2Z)-but-2-enedioic acid; N-[2-(dimethylamino)ethyl]-5-(1,2-dithiolan-3-yl)pentanamide
- Test material form:
- liquid: viscous
Constituent 1
In vitro test system
- Test system:
- isolated skin discs
- Remarks:
- Epidermal surface of skin
- Source species:
- rat
- Cell type:
- other:
- Cell source:
- other: Epidermal surface of skin
- Source strain:
- Wistar
- Vehicle:
- not specified
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 150µL of Test item and Control items respectively were applied uniformly to the epidermal surface for 24hours at 22°C.
- Duration of treatment / exposure:
- Test item and Control items were applied for 24hours at 22°C.
- Number of replicates:
- 3 replicates each for Test item, Positive control and Negative control.
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Value:
- 10.92
- Vehicle controls validity:
- not valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- The study "In-vitro Skin Corrosion by Transcutaneous Electrical Resistance Test Method" confirms that Substance is considered as non-corrosive as per the UN GHS for classification of Chemicals.
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