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EC number: 255-449-7 | CAS number: 41583-09-9
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study that is suitable for classification and labelling
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD: Draft Proposal for a New Guideline on In Vitro Skin Irritation: Human Skin Model Test of 06-Jun-2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3,5-triazine-2,4,6-triamine phosphate
- EC Number:
- 255-449-7
- EC Name:
- 1,3,5-triazine-2,4,6-triamine phosphate
- Cas Number:
- 41583-09-9
- Molecular formula:
- C3H6N6.xH3O4P
- IUPAC Name:
- Reaction product of 1,3,5-triazine-2,4,6-triamine and orthophosphoric acid
- Details on test material:
- - Name of test material (as cited in study report): CAS 41583-09-9, ID 10/0023/1
- Physical state: solid
- Analytical purity: 97.4%
- Impurities (identity and concentrations): 1.3% water
- Lot/batch No.: 00228CN9
- Expiration date of the lot/batch: January 2, 2014
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: The substance was homogenous by visual inspection
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: 00228CN9
- Expiration date of the lot/batch: January 2, 2014
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: The substance was homogenous by visual inspection
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- EPIDERM(TM) 200 kit from MaTek Corp, Ashland MA, USA
reconstructed epidermis, surface 0.6cm2 and cultured in vessels of 1 cm diameter.
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: not applicale
- Vehicle:
- other: no vehicle, moistened with water
- Controls:
- other: untreated skin tissue
- Amount / concentration applied:
- 25 μl applied to each tissue, spread to match tissue size.
- Duration of treatment / exposure:
- 60 min
- Observation period:
- 48h (recovery period, including 3h MTT incubation)
- Number of animals:
- not applicable
- Details on study design:
- To determine whether the test substance is able to reduce MTT directly, the test substance was incubated with the substrate.
Three tissues were treated with each test substance, positive and negative controls, espectively.
25 μL sterile PBS was applied first. Thereafter, a bulk volume of 25 μL of the test material was applied with a sharp spoon and homogeneously distributed together with the fluid.
Control tissues are concurrently applied with 30 μL sterile PBS or 5% SDS (positive control).
The tissues were kept under the laminar flow hood at room temperature for 25 minutes overall and for 35 minutes in the incubator. The tissues were washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues were blotted on sterile absorbent paper and transferred into new 6-well plates, pre-filled with 0.9 mL fresh medium. After all tissues had been rinsed, the surface of each tissue was carefully dried with a sterile cotton swab. Subsequently, the tissues were incubated in the incubator at 37°C for 24 ± 2 hours. After that the tissues were transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and placed into the incubator for additional 18 ± 2 hours post-incubation period.
After the postincubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in 2 mL isopropanol for at least 2 hours at room temperature on a plate shaker (ca. 120 rpm). After shaking the isopropanol extract and piercing the tissues, 2 aliquots of each extract per tissue were transferred to a 96-well microtiter plate. The optical density of the extracted formazan complex was determined spectrophotometrically using a filter with a wavelength of 570 nm.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: viability of reconstituted epidermis
- Value:
- 90
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of first experiment. Time point: 60 min. Max. score: 100.0. Reversibility: other: not applicable. Remarks: Score given in %. (migrated information)
- Irritation / corrosion parameter:
- other: other: viability of reconstituted epidermis
- Value:
- 99
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of second experiment. Time point: 60 min. Max. score: 100.0. Reversibility: other: not applicable. Remarks: Score given in %. (migrated information)
- Irritation / corrosion parameter:
- other: other: Absorbance 570 nm (OD)
- Value:
- 1.973
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of first experiment. Time point: 60 min. Max. score: 2.1808. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: Absorbance 570 nm (OD)
- Value:
- 2.062
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of second experiment. Time point: 60 min. Max. score: 2.0768. Reversibility: other: not applicable. (migrated information)
Any other information on results incl. tables
| first experiment | Tissue 1 | Tissue 2 | Tissue 3 | mean | SD | |
| Negative control | mean OD570 nm | 2.2577 | 2.1342 | 2.1507 | 2.1808 | |
| viability [% of negative control] | 103.5 | 97.9 | 98.6 | 100 | 3.07 | |
| melamine phosphate | mean OD570 nm | 1.9412 | * | 2.0047 | 1.9729 | |
| viability [% of negative control] | 89 | * | 91.9 | 90 | 2.06 | |
| 5% (w/v) sodium dodecyl sulfate | mean OD570 nm | 0.1302 | 0.1507 | 0.1487 | 0.1432 | |
| viability [% of negative control] | 6 | 6.9 | 6.8 | 7 | 0.52 | |
| "invalid tissue | ||||||
| second experiment | Tissue 1 | Tissue 2 | Tissue 3 | mean | SD | |
| Negative control | mean OD570 nm | 1.8535 | 2.3 | * | 2.0768 | |
| viability [% of negative control] | 89.3 | 110.7 | * | 100 | 15.2 | |
| melamine phosphate | mean OD570 nm | 2.152 | 1.924 | 2.1105 | 2.0622 | |
| viability [% of negative control] | 103.6 | 92.6 | 101.6 | 99 | 5.85 | |
| 5% (w/v) sodium dodecyl sulfate | mean OD570 nm | 0.1005 | 0.114 | 0.1 | 0.1048 | |
| viability [% of negative control] | 4.8 | 5.5 | 4.8 | 5 | 0.38 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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