Registration Dossier
Registration Dossier
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EC number: 947-548-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of N,N-Bis(2-hydroxypropyl)(C6-C18 even numbered and C18 unsatd)amides and bis(2-hydroxypropyl)ammonium myristate
- Molecular formula:
- No molecular formula. UVCB reaction mass.
- IUPAC Name:
- Reaction mass of N,N-Bis(2-hydroxypropyl)(C6-C18 even numbered and C18 unsatd)amides and bis(2-hydroxypropyl)ammonium myristate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- ColaLiquid DC-5, 100% active
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm system - cultured
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 microlitres of all articles.
- Duration of treatment / exposure:
- 35 +/- 1 minute @ 37C and then placed in a steril hood until the 60 minute exposure period was reached.
- Duration of post-treatment incubation (if applicable):
- 24 hours +/- 2 hours after washing.
- Number of replicates:
- Three
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 78.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- Value is 2.287 and lies between the range of >=0.8 - <=2.8 as per OECD 439
- Positive controls validity:
- valid
- Remarks:
- Value is 7.4% which is <=20% as required by the method
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mean value of three test data gave a value of 78.3% mean issue viability in the EpiDerm skin test (OECD 439).
Accoridng to the test protocol, a value of >50% predicts Non-Irritant under GHS classification
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