Registration Dossier
Registration Dossier
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EC number: 220-169-6 | CAS number: 2650-30-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 May 2017 to 21 November 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium 3,5,5-trimethylhexanoate
- EC Number:
- 220-169-6
- EC Name:
- Sodium 3,5,5-trimethylhexanoate
- Cas Number:
- 2650-30-8
- Molecular formula:
- C9H17O2.Na
- IUPAC Name:
- sodium 3,5,5-trimethylhexanoate
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Test system recommended in OECD Guideline.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDermTM (MatTek Corporation)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 uL undiluted test article
- Duration of treatment / exposure:
- 35 minutes at 37oC, 5% CO2 and =>95% humidity
Remaining time to 60 minutes in sterile hood
24h after thorough washing and fresh assay medium used - Duration of post-treatment incubation (if applicable):
- 18h post incubation period followed by:
-Thorough tissue rinse and drying
-Extract solution applied
-Sealed and incubated in the dark overnight
-Samples agitated for 15 minutes
-Each tissue pierced
-Extract was analysed on a microplate reader at 570nm - Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Second experiment performed at MatTek laboratories, Run 1
- Value:
- 7.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Second experiment performed at MatTek laboratories, Run 2
- Value:
- 7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Second experiment performed at MatTek laboratories, Run 3
- Value:
- 7.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The first experiment at the test facility failed and so a second experiment at MatTek laboratories was undertaken. The conclusion of this second experiment is that the Test Substance is classed as an Irritant according the GHS classification.
- Executive summary:
Test Substance is classed as an Irritant according the GHS classification.
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