Registration Dossier
Registration Dossier
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EC number: 815-096-7 | CAS number: 1421927-53-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-09-23 - 2016-10-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 (incl. QA statement)
Test material
- Reference substance name:
- 6,6'-(Ethane-1,2-diylbis(azanediyl))bis(dibenzo[c,e][1,2]oxaphosphinine-6-oxide)“
- EC Number:
- 815-096-7
- Cas Number:
- 1421927-53-8
- Molecular formula:
- C26H22N2O4P
- IUPAC Name:
- 6,6'-(Ethane-1,2-diylbis(azanediyl))bis(dibenzo[c,e][1,2]oxaphosphinine-6-oxide)“
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Cell source:
- other: not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:EpiDermTM-Kit, procured by MatTek
- Tissue batch number(s):23362
- Delivery date:11. Oct. 2016
- Date of initiation of testing:
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure:37 ± 1°C
- Temperature of post-treatment incubation (if applicable):37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps:
1 hour after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in 1-minute-intervals.
After rinsing, each tissue was blotted with sterile cellulose tissue and then transferred into a new 6-well-plate with fresh assay medium (0.9 mL).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration:1 mg/mL
- Incubation time:3 hours
- Spectrophotometer:plate spectrophotometer
- Wavelength:570 nm - Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- negative control: 30 µL DPBS buffer
positive control: 30 µL 5% SDS-solution
test item: 25.6 mg, 24.9 mg,25.7 mg - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 23 hours and 27 minutes at 37 ± 1°C
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- test item
- Value:
- 93.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control
- Value:
- 2.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
% Formazan Production
Designation |
EDA-DOPO |
Positive Control |
% Formazan production (tissue 1) |
99.2% |
2.9% |
% Formazan production (tissue 2) |
87.8% |
2.9% |
% Formazan production (tissue 3) |
94.0% |
2.8% |
% Formazan production (mean) |
93.6% |
2.9% |
± SD of mean Formazan production (%) |
5.7% |
0.1% |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- EDA-DOPO is considered as non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
- Executive summary:
Three tissues of the human skin model EpiDermTMwere treated with EDA-DOPO for 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size.
DPBS-buffer was used as negative control, 5% SDS solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 2.0. The positive control showed clear irritating effects. Relative absorbance was reduced to 2.9% (required: < 20%).
Variation within the tissue replicates was acceptable (required: ≤ 18%).
After the treatment with the test item, the relative absorbance values were reduced to 93.6 %. This value is above the threshold for skin irritation potential (50%).
Therefore, EDA-DOPO is considered as non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
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