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EC number: 267-104-8 | CAS number: 67800-80-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8-26 October 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Version 439, adopted 28. July 2015, “In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method”
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EU) No. 640/2012 amending Regulation (EC) No. 761/2009, Annex III, EU method B.46 “IN VITRO SKIN IRRITATION: RECON- STRUCTED HUMAN EPIDERMIS MODEL TEST”, adopted 06. Jul. 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methyl 2-[(2-methylundecylidene)amino]benzoate
- EC Number:
- 267-104-8
- EC Name:
- Methyl 2-[(2-methylundecylidene)amino]benzoate
- Cas Number:
- 67800-80-0
- Molecular formula:
- C20H31NO2
- IUPAC Name:
- methyl 2-[(2-methylundecylidene)amino]benzoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Name: Methyl 2-[(2-methylundecylidene)amino]benzoate
CAS No.: 67800-80-0
EINECS-No.: 267-104-8
Appearance: yellow liquid
Composition: Methyl 2-[(2-methylundecylidene)amino]benzoate
Purity: 87% (GC)
Homogeneity: homogeneous
Expiry date: 19. Mar. 2019
Storage: Room Temperature (20 ± 5°C)
The test item was stored in the test facility in a closed vessel at room temperature (20±5°C)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.
- Cell source:
- other: Organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo.
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It con- sists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on spe- cially prepared cell culture inserts.
Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati- slava.
Designation of the kit: EPI-200-SIT
Day of delivery: 23. Oct. 2018
Batch no.: 28665 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 µL/plate (6 well plate)
- Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 23 hours 25 minutes
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Replicate 1
- Value:
- ca. 114
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 3.9%
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Replicate 2
- Value:
- ca. 116.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 3.9%
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Replicate 3
- Value:
- ca. 103.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 3.5%
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of three replicates
- Value:
- ca. 111.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 3.7%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: OD >1.8 & <2.8 : 1.4
- Acceptance criteria met for positive control: <20% of negative control : 3.7%
- Acceptance criteria met for variability between replicate measurements: <18% : negative control 2.8% ; positive control 0.2% ; test item 6.7%
Therefore, the experiment is considered valid.
the outcome of the proficiency chemical testing is stated. All 10 profi- ciency chemicals were correctly classified.
The demonstration of proficiency was performed under non-GLP conditions but within the GLP-environment at LAUS GmbH.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Methyl 2-[(2-methylundecylidene)amino]benzoate is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
- Executive summary:
Findings and Results:
Two experiments were performed.
The first experiment was not valid, because the standard deviation of the three replicates of the negative control was 74.8%, required is ≤18 % and the OD of the negative control was not within the range (<0.8). This experiment is not reported, but the raw data are kept in the GLP archive of the test facility.
The second experiment was valid and the results are reported here.
Three tissues of the human skin model EpiDermTM were treated with the test item for 60minutes.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by thesupplier).
DPBS-buffer was used as negative control and 5% SDS solution was used as positive con- trol.
After treatment with the negative control, the mean absorbance value was within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.4.
The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 3.7% (required: <20%).
The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%).
After the treatment with the test item, the mean value of relative tissue viability was 111.5%. This value is well above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non-irritant to skin.
Therefore,
the test item Methyl 2-[(2-methylundecylidene)amino]benzoate is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
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