Registration Dossier
Registration Dossier
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EC number: 947-818-2 | 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:
- 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was not conducted under GLP conditions but was well-documented and suitable for classification.
Test material
- Reference substance name:
- Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate
- EC Number:
- 947-818-2
- Cas Number:
- 1612783-92-2
- Molecular formula:
- C15H28O2
- IUPAC Name:
- Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 1
- Expiration date of the lot/batch: No data
- Purity test date: 25 September, 2015
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, the test article was applied neat.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Three-dimensional reconstructed epidermal tissue model composed of keratinocytes
- Cell source:
- other: No data
- Source strain:
- other: None: Human source.
- Details on animal used as source of test system:
- No data
- Justification for test system used:
- The test system is validated as part of OECD 439.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek EpiDerm (EPI-200-SIT)
- Tissue batch number(s): No data
- Production date: No data
- Shipping date: No data
- Delivery date: 01 December, 2015
- Date of initiation of testing: 01 December, 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 C
- Temperature of post-treatment incubation (if applicable): 37 C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: With a constant gentle stream of DPBS from a wash bottle. The tissue culture inserts were filled and emptied approximately 20 times
- Observable damage in the tissue due to washing: None reported
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: No data
- Incubation time: 3 hours
- Spectrophotometer: No data
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be an irritant if the mean tissue viability is less than or equal to 50% following a 60 minute exposure to the tesr article. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 uL
NEGATIVE CONTROL : DPBS
- Amount(s) applied (volume or weight): 30 uL
POSITIVE CONTROL : 5% SDS
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 60 minute exposure to the test article
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Each test article or control was tested in triplicate.
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 uL
VEHICLE : None, tested neat
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL DPBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL SDS
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 60 minutes
- Observation period:
- The post exposure incubation period was 42 hours.
- Number of animals:
- None
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with DPBS
- Time after start of exposure: 60 minutes
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 93
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 98
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 94
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After a 60-minute exposure period and a 42-hour post-exposure period, the mean viability of the test article was 95%. MTDID 44430 is therefore considered to be not irritating to the skin.
- Executive summary:
The dermal irritation potential of MTDID 44430 was evaluated in EpiDerm per OECD 439. Human reconstructured epidermal tissues (n=3) were exposed to 30 uL of the test article (neat) for a 60 minute exposure period. Following the exposure period, the tissues were washed with DPBS and incubated for 42 hours. Following incubation, the tissue viability was measured via MTT assay and compared to the negative control. After a 60 -minute exposure period and a 42 -hour post-exposure period, the mean viability of the test article was 95% (93, 98, and 94%). MTDID 44430 is therefore considered to be not irritating to the skin.
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