Registration Dossier
Registration Dossier
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EC number: 242-424-0 | CAS number: 18559-94-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- 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
Test animals / tissue source
- Species:
- human
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- About 50 mg of test item were applied on the tissues surface.
- Duration of treatment / exposure:
- Exposure of test item: 6 hours.
- Duration of post- treatment incubation (in vitro):
- Post incubation: 18 hours.
- Number of animals or in vitro replicates:
- In this assay 2 replicates per test item, negative control, positive control, killed control (KU) and killed treated tissue (KT) were used.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Cell viability
- Value:
- 3.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Test item showed a strong reduced cell viability in comparison to the negative control. The mean viability of test item’s two replicates was 3.3 % of the mean value of negative control.
Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.
In this in vitro ocular irritation test with the EpiOcularTM model on test item “Salbutamol base” results indicated that the test item requires classification for eye irritation/serious eye damage [Category 1 or 2].
The definitive classification of the test item Salbutamol base is eye irritant (Category 2) since the preceding evaluation of the test item in the BCOP test (Study No CH-627/2016) showed a IVIS of 52.8 (no prediction can be made for serious eye damage, according to OECD no. 437, 2013). - Executive summary:
Title: Salbutamol base: In vitro Ocular Irritation Test with the EpiOcularTM Model.
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.
Test duration: Pre-treatment exposure with DPBS: 30 minutes.
Exposure of test item: 6 hours.
Post incubation: 18 hours.
Incubation conditions: 37 °C, 5 % CO2.
Validity of the controls: Positive control (Methyl Acetate) mean viability should be < 50 % of the negative control tissues.
The negative control OD should be >0.8 e < 2.5.
The difference of viability between the two relating tissues of a single chemicals is < 20% in the same run.
Results expression: The test item is considered to be at least irritant to corneal epithelium, if the mean relative viability after 30 minutes exposure and post incubation is less or equal (≤) to 60 % of the negative control.
Results: The mean viability of tissues exposed to the test item was 3.3 % of the mean negative control value.
In this in vitro ocular irritation test with the EpiOcularTM model on test item “Salbutamol base” results indicated that the test item requires classification for eye irritation/serious eye damage [Category 1 or 2].
The definitive classification of the test item Salbutamol base is eye irritant (Category 2) since the preceding evaluation of the test item in the BCOP test (Study No CH-627/2016) showed a IVIS of 52.8 (no prediction can be made for serious eye damage, according to OECD no. 437, 2013).
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