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Diss Factsheets

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:
2018

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

Constituent 1
Reference substance name:
Hydrolyzed Quinoa
EC Number:
825-815-6
Cas Number:
227025-12-9
IUPAC Name:
Hydrolyzed Quinoa
Constituent 2
Chemical structure
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

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.