Registration Dossier
Registration Dossier
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EC number: 205-265-8 | CAS number: 136-85-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- EU Method B.40-BIS
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP certificate is included in the Study Report attached
Test material
- Reference substance name:
- 6-methylbenzotriazole
- EC Number:
- 205-265-8
- EC Name:
- 6-methylbenzotriazole
- Cas Number:
- 136-85-6
- Molecular formula:
- C7H7N3
- IUPAC Name:
- 6-methylbenzotriazole
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch number: N6A3I
Expiry date: 04 August 2022
In vitro test system
- Test system:
- human skin model
- Cell type:
- other: Human Skin model EpiDerm: human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.
- Cell source:
- other: EpiDerm tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Human Skin model EpiDerm EPI-200-SCT
- Tissue batch number(s): 28600
- Delivery date: 24 April 2018
- Date of initiation of testing: 26 April 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Spectrophotometer: microtiter plate photometer Anthos Reader 2010 Flexi
- Wavelength:570 nm
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA :
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Negative control: demineralised water, prepared by LAUS GmbH, from a ion-exchnager, batch n°: 20180221.
Positive control: KOH, CAS n°: 1310-58-3, solution in demineralised water (8M), batch n°: 20170523. - Duration of treatment / exposure:
- 2 Durations of exposure: 3 min and 1 hour
- Duration of post-treatment incubation (if applicable):
- 1hour
- Number of replicates:
- 2
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Duration of exposure: 3 min; Mean of three runs with 2 replicates each.
Duration of exposure: 1 hour ; Mean of three runs with 2 replicates each. - Value:
- >= 9.7 - <= 104.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The criterion for optical density of the negative control (>= 0.8 and <= 2.8) was fulfilled: optical density was 1.5 (3 minutes) resp. 1.5 (1 hour).
The positive control showed clear corrosive effects. The criterion for the viability of the 1 hour experiment, expressed as % of the negative control (<15%), was fulfilled too. The mean value of relative tissue viability was 4.6%.
Values for negative control and for positive control were within the range of historical data of the test facility (see annex 2 page 19 of the Stufy report).
Therefore the experiment is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
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