Registration Dossier
Registration Dossier
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EC number: 610-641-3 | CAS number: 512802-65-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 January 2016 to 22 January 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- yes
- Remarks:
- An additional procedure using freeze-killed tissues was performed, but the results of this was not used because there was negligible interference. This deviation was considered not to affect the purpose or integrity of the study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- oils, palm, propoxylated
- EC Number:
- 610-641-3
- Cas Number:
- 512802-65-2
- Molecular formula:
- UVCB
- IUPAC Name:
- oils, palm, propoxylated
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- not specified
- Justification for test system used:
- As specified in the OECD Guidelines for this type of testing.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 3-minutes
60-minutes - Number of replicates:
- Duplicate tissues were exposed to the substance for each time point. The MTT assays were conducted in triplicates.
Test system
- Vehicle:
- unchanged (no vehicle)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-minute exposure
- Value:
- 88.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60-minute exposure
- Value:
- 103.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was considered to be non-corrosive to the skin.
- Executive summary:
In an in vitro skin corrosion study human skin tissue (epidermis keratinocytes) was exposed to the undiluted substance for 3-minutes and 1-hour. There was 88.8% and 103.7% tissue viability following the 3-minutes and 1-hour exposure points, respectively. Resultantly, the substance is considered to be non-corrosive to skin.
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