Registration Dossier
Registration Dossier
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EC number: 825-815-6 | CAS number: 227025-12-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experiment start: 04/3/2018 Experiment end: 04/[3/2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Test No. 432: In Vitro 3T3 NRU Phototoxicity Test
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- other: Test No. 432: In Vitro 3T3 NRU Phototoxicity Test
- Limit test:
- no
Test material
- Reference substance name:
- Hydrolyzed Quinoa
- EC Number:
- 825-815-6
- Cas Number:
- 227025-12-9
- IUPAC Name:
- Hydrolyzed Quinoa
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Test material form:
- liquid
- Details on test material:
- dark clear liquid
Constituent 1
Constituent 2
Test animals
- Species:
- other: Mouse fibroblast cell line, Balb/3T3 clone A31
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- other: 96-well microplates
- Vehicle:
- unchanged (no vehicle)
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- not specified
- Dose descriptor:
- other: Cmax
- Remarks:
- (-UV)
- Effect level:
- 1 000 other: µg/ml
- Based on:
- test mat.
- Key result
- Sex:
- not specified
- Dose descriptor:
- other: Cmax
- Remarks:
- (+UV)
- Effect level:
- 1 000 other: µg/ml
- Based on:
- test mat.
Any other information on results incl. tables
| Conc. (µg/ml) | 100 | 133 | 178 | 237 | 316 | 422 | 563 | 750 | 1000 |
| (-UV) | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 2% | 0% |
| (+UV) | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% |
No significant cytototoxic effect was recorded as well without UVA exposure as after exposure to UVA. The concentration resulting in 50% reduction of cell viability with and without UVA can not be calculated. Therefore, the Cmax (-UV) was estimated to 1000 µg/ml. The Cmax (+UV) was estimated to 1000 µg/ml.
Applicant's summary and conclusion
- Conclusions:
- No significant cytototoxic effect was recorded as well without UVA exposure as after exposure to UVA. The concentration resulting in 50% reduction of cell viability with and without UVA can not be calculated. Therefore, the Cmax (-UV) was estimated to 1000 µg/ml. The Cmax (+UV) was estimated to 1000 µg/ml.
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