Registration Dossier
Registration Dossier
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EC number: 946-742-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- / Test conducted according to an acknowledged in vitro test procedure referred to as MatTek Corporation EpiDermTM Skin Model testing system, which in principle is similar to OECD TG 431 and 439.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Principles of method if other than guideline:
- Test conducted according to an acknowledged in vitro test procedure referred to as MatTek Corporation EpiDermTM Skin Model testing system, which in principle is similar to OECD TG 431 and 439.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]docosanamide
- EC Number:
- 262-134-8
- EC Name:
- N-[3-(dimethylamino)propyl]docosanamide
- Cas Number:
- 60270-33-9
- Molecular formula:
- C27H56N2O
- IUPAC Name:
- N-[3-(dimethylamino)propyl]docosanamide
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- EpiDerm Skin model closely parallels human skin. It consists of highly organized basal, spinous, granular and cornified layers analogous to those found in vivo.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek EpiDerm Skin model, Ashland, USA
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: The inserts were rinsed two times.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Incubation time: 3 h
- Spectrophotometer: Dynatech MR 4000 Automatic Microplate reader
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1 - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 µg
NEGATIVE CONTROL
- Amount(s) applied: 100 µL - Duration of treatment / exposure:
- 1, 4.5 and 20 h
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- value of test item (100%) after 1 h
- Value:
- 85
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- value of test item (100%) after 4.5 h
- Value:
- 107
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- value of test item (100%) after 24 h
- Value:
- 82
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Other effects / acceptance of results:
- Based on the MatTek Corporation grouping, the substance is expected to be non-corrsoive and non-irritating to skin.
Any other information on results incl. tables
The time at which the percent viablility would be 50% (ET 50) was estimated by interpolation: >24 h.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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