Registration Dossier
Registration Dossier
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EC number: 678-448-7 | CAS number: 3084-53-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 20 to 22, 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- trimethylsulfanium bromide
- EC Number:
- 678-448-7
- Cas Number:
- 3084-53-5
- Molecular formula:
- C3H9BrS
- IUPAC Name:
- trimethylsulfanium bromide
Constituent 1
- Specific details on test material used for the study:
- Lot number: 21MR1-2
Purity: 99%
In vitro test system
- Test system:
- human skin model
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: reconstructed
- Details on animal used as source of test system:
- SOURCE ANIMAL
- Source: EpidermTM tissues from MatTek Corporation. - Justification for test system used:
- The test systetm (non-transformed human-derived epidermal keratinocytes cultured to form a complex model of the human epidermis) was validated and approved by regulatory authorities for evaluation of skin irritation potential.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpidermTM tissues
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37.2oC
- Temperature of post-treatment incubation (if applicable):
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: tissues were rinsed with sterile DPBS by filling and emptying the tissue insert at least 15 times to remove any residual test material.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: in 96-well plate
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3 replicates in each group
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues
- Procedure used to prepare the killed tissues (if applicable):
- N. of replicates : 3
- Method of calculation used:
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritating to skin if the viability after 1 hour exposure is less than or equal to 50%.
- The test substance is considered to be non-irritating to skin if the viability after 1 hour exposure is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
- Concentration (if solution):
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 18 hours
- Number of replicates:
- 3 replicates per group
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 62.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Positive and negative controls performed as expected and all validity criteria were met.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, TMSBr is considered a non-irritant.
- Executive summary:
The in vitro Epiderm skin irritation test was performed using three-dimensional RHE tissue, according to OECD Guideline 439 under GLP.
Under the conditions of the study, TMSBr is considered a non-irritant.
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