Registration Dossier
Registration Dossier
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EC number: 273-222-0 | CAS number: 68953-64-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental starting date :November 8, 2017 - Experimental completion date : November 10, 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 22, 2010
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Ashland testing laboratory works with Standard Operating Procedures.
Test material
- Reference substance name:
- 1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides
- EC Number:
- 273-222-0
- EC Name:
- 1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides
- Cas Number:
- 68953-64-0
- Molecular formula:
- UVCB: CnHnN2 O2 (Cl)
- IUPAC Name:
- 1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides
Constituent 1
- Specific details on test material used for the study:
- Chemical name: CERAPHYL™ 65
Code 826812
Batch number 0001954899
Supplier Ashland
Dry matter (%) 59.4%
Physical state Clear amber to dark amber liquid
pH 7.6
Solvent Propylene Glycol
Treatment None
Storage conditions Room Temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- - Ashland 0.5 cm2 reconstructed epidermis from normal human keratinocytes.
- Batch N°: 1710EPID02
- Origin: Foreskin
- Quality Controls: Certified by Ashland Tissue Engineering laboratories, 06/11/2017
- Cells were grown on inert polycarbonate filter on chemically defined medium, airlifted for 17 days
- 3 tissues were used for each chemical.
- The RHE tissues were incubated at 37°C, 5% CO2 until test substance application (usually 24 hours). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Neat
- Duration of treatment / exposure:
- 42 minutes
Procedure:
. Fill a 24-well plate with 300μl by well of pre-warmed maintenance culture medium.
· Transfer tissues.
· Dispense 16 μL ± 0.5 μL (or 16 μg) of products and controls on the top of epidermis.
· Carefully apply a nylon mesh (Ø = 7.5mm) on the whole surface with forceps.
· Keep the plates containing the treated epidermis for 42 minutes at room temperature. - Duration of post-treatment incubation (if applicable):
- 42 hours and MTT incubation for 3 hours.
Procedure:
· Remove the nylon mesh with fine forceps from the epidermal surface of a treated tissue.
· Remove the treated units using forceps, and rinse thoroughly 25 times with 1 ml DPBS.
· Transfer the washed tissue on 2 mL growth culture medium (6-well plate).
· Incubate the treated and rinsed epidermis at 37°C, 5% CO2 for 42 hours (± 60 minutes).
Assessment of non-specific MTT reduction (NSMTT)
· To identify direct MTT reducers, each test chemical should be added to freshly prepared MTT solution. If the MTT mixture containing the test chemical turns blue/purple, the test chemical is presumed to directly reduce MTT and a further functional check on non-viable RhE tissues should be performed.
· Each MTT reducing test chemical is applied on at least two killed tissue replicates which undergo the entire testing procedure to generate a non-specific MTT reduction (NSMTT) - Number of replicates:
- 3 per group: Negative control, Quaternium-26, Positive control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main
- Value:
- 120.8
- 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
- Executive summary:
According to ASHLAND EQUIVALENT EPIDERMISES SKIN IRRITATION test, CERAPHYL™ 65 is classified as Non irritant.
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