Registration Dossier
Registration Dossier
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EC number: 931-105-8 | 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:
- 08-12/2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- MatTek EpiDerm MTT Viability Assay
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of L-isoleucine and octadecan-1-ol and ethanesulphonic acid and docosan-1-ol
- EC Number:
- 931-105-8
- Cas Number:
- 1156505-34-8
- Molecular formula:
- C26-30H56-64O5NS
- IUPAC Name:
- Reaction mass of L-isoleucine and octadecan-1-ol and ethanesulphonic acid and docosan-1-ol
- Reference substance name:
- Reaction mass of docosan-1-ol and octadecan-1-ol
- Molecular formula:
- C18-22H38-46O
- IUPAC Name:
- Reaction mass of docosan-1-ol and octadecan-1-ol
- Test material form:
- solid: flakes
Constituent 1
Constituent 2
In vitro test system
- Test system:
- human skin model
- Remarks:
- Reconstructed Human Epidermis (RHE)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- no animal used
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- test material used as received, undiluted
- 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:
- 87.8
- 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:
A study was conducted to evaluate the skin irritation potential of the tests substance according to OECD 439. It is expected that the substance is not skin irritant.
The substance is non irritant according to EpiDerm MTT Viability Assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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