Registration Dossier
Registration Dossier
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EC number: 294-347-7 | CAS number: 91697-85-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19.06.2018 - 09.08.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- Adopted 29. July 2016
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
- EC Number:
- 294-347-7
- EC Name:
- Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
- Cas Number:
- 91697-85-7
- Molecular formula:
- Not available
- IUPAC Name:
- Fatty acids, tallow, hydrogenated, reaction products with diethanolamine
- Test material form:
- solid: bulk
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Human-derived epidermal keratinocytes
- Cell source:
- other: Multilayered, highly differentiated model of the human epidermis, EpiDerm Skin Model
- Source strain:
- other: EPI-200, Lot no.: 28811, kit L and M (see appendix 4)
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- other:
- Details on test system:
- The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50.3, 56.8 mg
- Duration of treatment / exposure:
- 3 minutes
- Duration of post-treatment incubation (if applicable):
- 1 hour
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3-minute application
- Run / experiment:
- 4
- Value:
- >= 103 - <= 103
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 1-hour application
- Run / experiment:
- 4
- Value:
- >= 103 - <= 103
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Executive summary:
In conclusion, 35730 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report (OECD 431).
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