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EC number: 831-167-5 | CAS number: 2126827-44-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6th February 2019 - 8th February 2019
- 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- Adopted 29th July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Guideline No. 440/2008. Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test".
- Version / remarks:
- Official Journal of the European Union No. L142, 31 May 2008.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,9,16,23-tetrakis(2,5-di-tert-butyl-4-methoxyphenoxy)phthalocyanine
- EC Number:
- 831-167-5
- Cas Number:
- 2126827-44-7
- Molecular formula:
- C92H106N8O8
- IUPAC Name:
- 2,9,16,23-tetrakis(2,5-di-tert-butyl-4-methoxyphenoxy)phthalocyanine
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch (Lot) Number: 2715/18/01
Expiry date: 01 July 2020
Physical Description: Dark green solid
Purity/Composition: 99%
Storage Conditions: At room temperature protected from light
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Cultured to form a multilayered, highly differentiated model of the human epidermis
- Source strain:
- other: Not applicable
- Details on animal used as source of test system:
- EpiDerm Skin Model (EPI-200, Lot no.: 29944 Kit I and J).
- Justification for test system used:
- Recommended system according to the OECD 431 and EC TG.
- Vehicle:
- unchanged (no vehicle)
- 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
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- Substance: 25.4 to 41.6 mg per tissue
Positive control: 50 μL per tissue
Negative control: 50 μL per tissue - Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hours at 37°C in air containing 5% CO2.
- Number of replicates:
- Duplicate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3-minute time point
- Run / experiment:
- mean of two samples
- Value:
- ca. 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minute time point
- Run / experiment:
- Mean of two samples
- Value:
- ca. 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of corrosion
- Other effects / acceptance of results:
- The non-specific reduction of MTT by the substance was -7.4% and 2.2% of the negative control tissues after 3 minutes and 1 hour, respectively.
In addition to the normal 3-minute and 1-hour procedure, two tissues were treated with substance instead of MTT solution these tissues were incubated with DMEM. The color interference by the substance was 5.4% and 7.3% of the negative control tissues after 3 minutes and 1 hour respectively.
For the true tissue viability to be calculated, in addition to the normal 3-minute and 1-hour procedure, two freeze-killed tissues treated with test item were used but instead of MTT solution these tissues were incubated with DMEM. The nonspecific color in freeze-killed tissues by the substance was 2.8% and 4.4% of the negative control tissues after 3 minutes and 1 hour respectively.
Any other information on results incl. tables
Mean Absorption in the in vitro Skin Corrosion Test
|
3 -minute application viability (%) |
1 -hour application viability (%) |
||||||
A (OD570) |
B (OD570) |
Mean (OD570) |
SD (+/-) |
A (OD570) |
B (OD570) |
Mean (OD570) |
SD (+/-) |
|
Negative control |
1.375 |
1.511 |
1.443 |
0.097 |
1.316 |
1.538 |
1.427 |
0.157 |
Substance* |
1.279 |
1.423 |
1.351 |
0.101 |
1.281 |
1.562 |
1.422 |
0.199 |
Positive control |
0.511 |
0.324 |
0.087 |
0.132 |
0.250 |
0.117 |
0.183 |
0.094 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
* For the 3 minute exposure the substance values are corrected for the color interference (5.4%).
For the 1 hour exposure the substance values are corrected for the non-specific MTT reaction and color interference (2.2%
and 7.3 %, respectively). In addition these values are corrected for the nonspecific color in freeze-killed tissues (4.4%).
The values are corrected for background absorption (0.0475). Isopropanol was used to measure the background absorption.
Mean Tissue Viability in the in vitro Skin Corrosion Test
3 -minute application viability (% of control) |
1 -hour application viability (% of control) |
|
| Negative control | 100 | 100 |
| Substance | 94 | 100 |
| Positive control | 29 | 13 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this study.
- Executive summary:
In a reliable in vitro skin corrosion study, conducted according to the OECD Guideline 431, 'In Vitro Skin Corrosion: reconstructed human epidermis (RHE) test method', the undiluted substance ( 25.4 to 41.6 mg) was applied onto reconstructed human skin tissue (epidermal model, EpiDerm tissue (0.6 cm²)) in duplicate for a period of 3 or 60 minutes.
Skin corrosion is expressed as the remaining cell viability after exposure to the substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the substance compared to the negative control tissues was 94 % and 100 %, respectively. Because the mean relative tissue viability for the substance was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the substance is considered to be non corrosive.
In conclusion, the substance is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this study.
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