Registration Dossier
Registration Dossier
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EC number: 913-660-8 | 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:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
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:
- EPIDERM MTT VIABILITY ASSAY
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reaction mass of glycerol and N-[3-(dimethylamino)propyl]stearamide and N-[3-(dimethylamino)propyl]docosanamide
- Molecular formula:
- C21 H50 N O C23 H54 N O C25 H58 N O C27 H62 N O
- IUPAC Name:
- Reaction mass of glycerol and N-[3-(dimethylamino)propyl]stearamide and N-[3-(dimethylamino)propyl]docosanamide
- Test material form:
- solid: flakes
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent positive control
- Amount/concentration applied:
- neat 100 microLitre
- Duration of treatment / exposure:
- 1, 4, and 24 hrs
- Number of replicates:
- each treatment was conducted in duplicate
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- ET50 (hr) > 24
- Value:
- 61.3
- 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 is non irritant according to EpiDerm MTT Viability Assay.
- Executive summary:
The substance is non irritant according to EpiDerm MTT Viability Assay.
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