Registration Dossier
Registration Dossier
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EC number: 947-349-3 | 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:
- 01/03/2016 - 26/04/2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals No. 439: In Vitro Skin Irritation: Reconstructed human Epidermis Test Method, 28 July 2015
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[dimethyl({3-[(10E,13E)-nonadeca-10,13-dienamido]propyl})azaniumyl]acetate
- Molecular formula:
- C25H47N2O3 (if R= C18:2)
- IUPAC Name:
- 2-[dimethyl({3-[(10E,13E)-nonadeca-10,13-dienamido]propyl})azaniumyl]acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- The test material corresponded to the approximately 45% of the registration substance in water.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EPISKIN-SM™ (SkinEthic)
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test material corresponds to the approximately 45% of regstration substance in water.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 µl
- Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 100.8
- 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:
- Based on the results of the present study, the registration substance is not skin irritating.
- Executive summary:
The skin irritation property of the registration substance was investigated according to the OECD Gudieline 439. The reconstructed skin model was used as test system. No significant reduction in the cell viability was found after 15 min treatment with 10 µl test material which corresponded to 45% of the registration substance in water. No significant skin irritation property could be derived. No classification is warranted.
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