Registration Dossier
Registration Dossier
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EC number: 221-053-8 | CAS number: 2986-54-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 22 April - 23 August 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- July 27, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methoxycyclododecane
- EC Number:
- 221-053-8
- EC Name:
- Methoxycyclododecane
- Cas Number:
- 2986-54-1
- Molecular formula:
- C13H26O
- IUPAC Name:
- methoxycyclododecane
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Validation studies have shown that tests employing human skin models are able to discriminate between known skin corrosives (Optional sub-category 1A, optional subcategory 1B and 1C) and non-corrosives. The test protocol may also enable the distinction between severe and less severe skin corrosives.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Kit
- Tissue batch number: 23338
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 °C, for exposure of 3 ± 0.5 min at room temperature
- Temperature of post-treatment incubation: 37 ± 1.5 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: 20 times, no defined volume
- Modifications to validated SOP: There was the following alteration from the MatTek test protocol: Concerning exposure conditions (chapter 3.6.2): Only the 6-well plates for the 60 ± 5 minutes exposure period was placed into an incubator (37 ± 1.5 °C, 5 ± 0.5% CO2) during treatment, the wells for the 3 ± 0.5 minutes exposure periods stayed at room temperature in the sterile bench.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: microplate reader: Versamax®, Molecular Devices, SoftMax Pro Enterprise (version 4.7.1)
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The test item did not prove to be a MTT reducer and the test item did not dye water.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
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% (Cat. 1A), 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% (Cat. 1B and 1C).
- 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
- other: Controls for MTT assay
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 μL (79.4 μL/cm2) - Duration of treatment / exposure:
- 3 min and 1 h
- Duration of post-treatment incubation (if applicable):
- 3 h MTT incubation, 67.5 h extraction
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 94.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100 %
- Positive controls validity:
- valid
- Remarks:
- 16.2 %
- Remarks on result:
- other: no indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h exposure
- Value:
- 91.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100 %
- Positive controls validity:
- valid
- Remarks:
- 10.7
- Remarks on result:
- other: on indication of corrosion
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- not GHS cat. 1
- Conclusions:
- The test substance was determined to be non-corrosive in the in vitro human skin model test with EpiDerm.
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