Registration Dossier
Registration Dossier
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EC number: 263-233-9 | CAS number: 61800-40-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21st February 2013 - 28th March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- hydrogenation products of (esterification products of 2-ethylhexan-1-ol with (Estolide formation products of oleic acid and Fatty acids, C8-18 and C18-unsatd. (branched or linear))
- IUPAC Name:
- hydrogenation products of (esterification products of 2-ethylhexan-1-ol with (Estolide formation products of oleic acid and Fatty acids, C8-18 and C18-unsatd. (branched or linear))
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- MatTek’s patented EpiDerm tissue samples were used:
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µl of the test article were applied to the top of each EpiDerm tissue. The nylon mesh was then placed on top to facilitate even distribution of the test material. The test article remained in contact with the EpiDerm tissue for 3 and 60 minutes.
- Duration of treatment / exposure:
- The test article remained in contact with the EpiDerm tissue for 3 and 60 minutes.
- Duration of post-treatment incubation (if applicable):
- At the end of the exposure period, each EpiDerm™ tissue was rinsed with phosphate buffered saline (PBS) and transferred to a 24-well plate containing 300 µI of MIT solution (1 mg/ml MIT in OMEM). The tissues were then returned to the incubator for a three-hour MTT incubation period. Following the MIT incubation period, each EpiDerm tissue was rinsed with PBS and then treated overnight with 2.0 ml of extractant solution (isopropanol) per well. The absorbency of an aliquot of the extracted MIT formazan was measured in triplicate at 540 nm using a microplate reader (µQuant Plate Reader, BioTek Instruments, Winooski, VT).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 Min - 1st experiment
- Value:
- 85.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 Min - 2nd Experiment
- Value:
- 85.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minm - 1st experiment
- Value:
- 98.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minm - 2nd experiment
- Value:
- 99.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Quality Controls:
The mean OD of the Negative Control tissues was 2.212 at 3 minutes and 2.065 at 60 minutes, which met the acceptance criterion.
The mean relative tissue viability of the 60-minute Positive Control was 3.8%, which met the acceptance criterion.
Viability differences between the two identically treated tissues in all samples and controls at 3 minutes were 0.5% to 4.5%. Viability differences between the two identically treated tissues at 60 minutes were 0.3% to 9.3%. Inter-tissue viability differences at both time points met the acceptance criterion.
Any other information on results incl. tables
| Test Article Identity | viability (3 min) | viability (60 min) | Predicted corrosivity |
| CAS# 1365345-64-7 (SE7B Batch 2137-0) | 85.5 % | 98.8 % | Non - corrosive |
| Tissue culture water (Negative Control) | 100.0 % | 100.0% | Non - corrosive |
| Potassium Hydroxide, 8.0 N (Positive Control) | 22.2 % | 3.8% | Corrosive |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the test material is not corrosive to the skin.
- Executive summary:
OBJECTIVE: To predict and classify the skin corrosivity potential of a chemical by using a three dimensional human epidermis model. This protocol follows the procedures outlined in OECD Test Guideline 431, effective April 2004. METHOD SYNOPSIS: MatTek EpiDerm™ tissue samples were treated in duplicate with the test article, Negative Control and Positive Control for 3 minutes and 60 minutes. Following treatment, the viability of the tissues was determined using Methyl thiazole tetrazolium (MTT) uptake and conversion, and the absorbance of each sample was measured at 540 nm. The viability was then expressed as a percent of control values. The percent viability was used to determine corrosivity potential.
SUMMARY/CONCLUSION:
The results of the study can be seen below:
Test Article Identity viability (3 min) viability (60 min) Predicted corrosivity CAS# 1365345-64-7 (SE7B Batch 2137-0) 85.5 % 98.8 % Non - corrosive Tissue culture water (Negative Control) 100.0 % 100.0% Non - corrosive Potassium Hydroxide, 8.0 N (Positive Control) 22.2 % 3.8% Corrosive Based on the results of the study the test material is not corrosive. The test material will not be classified as corrosive, according to CLP.
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