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EC number: 884-585-5 | CAS number: 270586-78-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [bis(4-methylphenyl)phosphoroso](2,4,6-trimethylphenyl)methanone
- EC Number:
- 884-585-5
- Cas Number:
- 270586-78-2
- Molecular formula:
- C24H25O2P
- IUPAC Name:
- [bis(4-methylphenyl)phosphoroso](2,4,6-trimethylphenyl)methanone
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM tissue
- Details on animal used as source of 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 consists 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 specially pre-pared cell culture inserts. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Test animals
- Species:
- other: EpiDermTM tissue
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- yes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 93.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
1.1 Comparison of Tissue Viability
For the test item and the positive control, the following percentage values of tissue viability were calculated in comparison to the negative control:
Table 9.2 % Tissue Viability
Designation | Test Item (di-p-tolylphosphoryl)(mesityl)methanone | Positive Control |
% Tissue viability (tissue 1) | 96.9 % | 2.6 % |
% Tissue viability (tissue 2) | 92.4 % | 3.0 % |
% Tissue viability (tissue 3) | 91.6 % | 2.9 % |
% Tissue viability (mean) | 93.6 % | 2.8 % |
± SD of mean tissue viability (%) | 2.9 % | 0.2 % |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item (di-p-tolylphosphoryl)(mesityl)methanone is considered non- irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
- Executive summary:
One valid experiment was performed.
Three tissues of the human skin model EpiDermTM were treated with the test item for 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier).
DPBS-buffer was used as negative control and 5 % SDS solution was used as positive control.
After treatment with the negative control, the mean absorbance value was within the re-quired acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.642.
The positive control showed clear irritating effects. The mean value of relative tissue via-bility was reduced to 2.8 % (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 re-duced to 93.6 %. This value is 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 (di-p-tolylphosphoryl)(mesityl)methanone is considered non- irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
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