Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16/05/2017-18/06/2017
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Council regulation 440/2008, Method B.40 BIS:"In vitro skin Corrision:Human skin model Test", May 30, 2008
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Corporation protocol for: In Vitro EpiDerm TM Skin Corrosion Test (EPI-200-SCT) For Use with MatTek Corporation's reconstructed Human Epidermal Model EpiDerm; Version 07/11/2014.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Raction product of 2-Ethyl-1-hexylamine and 3-(2-Ethylhexyloxy)propylamine with 4-bromo-1,8 naphthalic anhydride
- Cas Number:
- 1971906-58-7
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Raction product of 2-Ethyl-1-hexylamine and 3-(2-Ethylhexyloxy)propylamine with 4-bromo-1,8 naphthalic anhydride
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 78-242-15
- Expiration date of the batch: 01/02/2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
- Stability under test conditions: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was applied undiluted. 50 µL of the test item was dispensed directly atop the EpiDerm TM tissue. The test item was spread to match size of the tissue. A nylon mesh was used as spreading aid.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 3 minutes
- Value:
- >= 50
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 60 minutes
- Value:
- >= 15
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
Any other information on results incl. tables
The test item showed no non-specific MTT-reducing potential but it showed colouring after mixture with isopropanol. Therefore, NSClivingwas determined. No correction of results was necessary because NSClivingwas below 5% (3 min treatment: 0.3%; 60 min treatment: 0.6%).
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was³ 50% (104.7%) after 3 min treatment and³ 15% (93.8%) after 60 min treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. the test item is classified as "non-corrosive".
- Executive summary:
In the present study the skin corrosivity potential of the test item was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDermÔ, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The test item showed no non-specific MTT-reducing potential but it showed colouring after mixture with isopropanol. Therefore, NSClivingwas determined. No correction of results was necessary because NSClivingwas below 5% (3 min treatment: 0.3%; 60 min treatment: 0.6%).
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was³ 50% (104.7%) after 3 min treatment and³ 15% (93.8%) after 60 min treatment.
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