Registration Dossier
Registration Dossier
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EC number: 209-527-2 | CAS number: 584-03-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 May – 26 May 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)
- Version / remarks:
- Adopted: July 28, 2015
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Butane-1,2-diol
- EC Number:
- 209-527-2
- EC Name:
- Butane-1,2-diol
- Cas Number:
- 584-03-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,2-diol
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- LabCyte EPI-MODEL24 SIT
- Source species:
- human
- Cell type:
- other: human epidermal cells
- Justification for test system used:
- LabCyte EPI-MODEL24 SIT is recommended in the test guideline OECD 439
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: LabCyte EPI-MODEL24 SIT
- Tissue batch number : LCE24-160509-A
- Delivery date: May 10, 2016
- Date of initiation of testing (exposure to test substance): May 11, 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Tissues were rinsed fifteen times or more with PBS (-)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.5 mg/mL
- Incubation time: 180 min
- Spectrophotometer: Multimode Microplate Reader
- Wavelength: 570 nm and 650 nm
ACCEPTABILITY CRITERIA
- Negative control: Mean measurement value 0.7 < OD < 2.5
- Positive control: cell viability ≤ 40 %
- SDs of cell viabilities in each treatment group ≤ 18 %
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD = 1.3 (within acceptance criteria of 0.7 < OD < 2.5)
- Barrier function: IC50 = 0.26 (within acceptance criteria of 0.14% < IC50 < 0.40%)
- Morphology: multilayered epidermis with a stratum corneum observed
NUMBER OF REPLICATE TISSUES: 3 replicates
PREDICTION MODEL / DECISION CRITERIA.
- The test substance is considered to be classified to EU CLP Category 1 or 2 if the mean percent tissue viability after exposure and post-treatment incubation is less than or equal to 50%
- The test substance is considered to be non-irritant to skin if the tissue viability after exposure and post-treatment incubation is more than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied : 25 µL applied onto each tissue at 1 min interval
NEGATIVE CONTROL
- Amount applied : 25 µL applied onto each tissue at 1 min interval
POSITIVE CONTROL
- Amount applied : 25 µL applied onto each tissue at 1 min interval - Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3 replicates
Test system
- Type of coverage:
- other: In-vitro system
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of the test item
- Value:
- 98.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes. The negative control OD measurement is 0.9.
- Acceptance criteria met for positive control: yes. The positive control reduced the viability of cells to 1.9 %
- Acceptance criteria met for variability between replicate measurements: yes. The SDs of cell viabilities in the negative control, the positive control and the test substance is 4.4 %, 0.2 % and 5.0 %, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to CLP
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