Registration Dossier
Registration Dossier
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EC number: 242-424-0 | CAS number: 18559-94-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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 (incl. QA statement)
Test material
- Reference substance name:
- Salbutamol
- EC Number:
- 242-424-0
- EC Name:
- Salbutamol
- Cas Number:
- 18559-94-9
- Molecular formula:
- C13H21NO3
- IUPAC Name:
- 4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of test item
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- Post incubation: 42 hours.
- Number of replicates:
- 3 replicates per test item; 3 replicates negative control and 3 replicates positive controls.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 97.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Test item showed no reduced cell viability in comparison to the negative control. The mean viability of test item’s three replicates results was 97.1 % of the mean negative control value.
Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.
In this in vitro skin irritation test with the EpiDermTM model on test item “SALBUTAMOL BASE” results indicated that the test item is Non-irritant to skin [No Category according to EU CLP and UN GHS]. - Executive summary:
Title: In vitro skin irritation test on “SALBUTAMOL BASE” with the EpiDermTM model.
Guidelines: OECD Guidelines for the Testing of Chemicals No. 439, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”. Adopted 28 July 2015.
Purpose: The irritation potential of the test item was predicted by measurement of its cytotoxic effect, as reflected in the MTT [3- (4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue tetrazolium bromide; CAS number 298-93-1] assay, on the reconstructed human epidermis model (RhE).
Evaluations: The cell viability based on cellular mitochondrial dehydrogenase activity, measured by MTT reduction and conversion into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of cell viability in treated tissues was compared to negative control and expressed as a %. The % reduction in viability is used to predict the irritation potential.
Deviations from the Study Plan:
1- Storage conditions for the reference item DPBS are room temperature instead 2-8°C as reported in the Study Plan.
2- The correct test item batch number is 01416 instead 014616 as reported in the Study Plan.
These deviations don’t affect the results.
Test duration: Exposure of test item: 60 minutes.
Post incubation: 42 hours.
Incubation conditions: 37 °C, 5 % CO2, 95 % RH
Validity of the controls:
1) Positive control (Sodium dodecyl sulphate 5 % aq.) mean viability should be 20 % of the negative control tissues.
2) The mean OD value of the three negative control tissues (DPBS) should be 1.0 e 2.5.
3) For all treated group the standard deviation value (SD) of the % viability should be < 18 %.
Results expression: The test item is considered to be at least irritant to skin, if the mean relative viability is 50 % of the negative control.
Results: The mean viability of tissues exposed to the test item was 97.1 % of the mean negative control value.
In this in vitro skin irritation test with the EpiDermTM model on test item “SALBUTAMOL BASE” results indicated that the test item is Non-irritant to skin [No Category, according to EU CLP and UN GHS].
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