Registration Dossier
Registration Dossier
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EC number: 254-447-3 | CAS number: 39430-51-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of chromium picolinate and its components in Salmonella typhimurium and L5178Y mouse lymphoma cells.
- Author:
- Whittaker, P. et al.
- Year:
- 2 005
- Bibliographic source:
- Food and Chemical Toxicology 43, 1619-1625
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 14639-25-9
- EC Number:
- 604-524-6
- Cas Number:
- 14639-25-9
- IUPAC Name:
- 14639-25-9
- Reference substance name:
- Chromium picolinate
- IUPAC Name:
- Chromium picolinate
- Details on test material:
- - Name of test material (as cited in study report): chromium picolinate, ESDA
- Molecular formula (if other than submission substance): C18H12CrN3O6
- Analytical purity: 99%
Constituent 1
Constituent 2
Method
- Target gene:
- thymidine kinase
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Fischer's medium for leukemic cells of mice supplemented with 10% horse serum and 0.02% pluronic F-68
- Periodically checked for Mycoplasma contamination: yes - Additional strain / cell type characteristics:
- other: 3.7.C
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from Aroclor 1254-induced male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- 50, 150, 500 and 1000 µg/mL
- Vehicle / solvent:
- distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9: methyl methanesulfonate; with S9: 7,12-dimethylbenzanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Exposure duration: 4 h
- Expression time (cells in growth medium): 48 h
- Selection time (if incubation with a selection agent): 10 - 12 days
- Fixation time (start of exposure up to fixation or harvest of cells): 12 - 14 days
SELECTION AGENT (mutation assays): trifluorothymidine (TFT, 3 µg/mL)
NUMBER OF REPLICATIONS: duplicate cultures, three plates
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
OTHER EXAMINATIONS:
- Other: Determination of colony size - Evaluation criteria:
- Indication of a mutagenic activity if there was evidence of a dose response with at least one concentration giving an increase in mutant frequency of at least 100 mutants per 1E+6 surviving cells above the concurrent control value.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Dose [µg/mL] |
Rat S9 |
Relative total growth [% of control] |
Mutant frequency/106 survivors |
|
Solvent control |
0 |
- |
100.0 |
85 |
50 |
- |
98.5 |
122 |
|
150 |
- |
84.5 |
87 |
|
500 |
- |
76.0 |
380 |
|
1000 |
- |
58.5 |
400 |
|
Positive control (MMS) |
10 |
- |
43.0 |
401 |
Solvent control |
0 |
+ |
100.0 |
60 |
50 |
+ |
114.5 |
61 |
|
150 |
+ |
94.5 |
94 |
|
500 |
+ |
86.5 |
237 |
|
1000 |
+ |
31.5 |
387 |
|
Positive control (DMBA) |
4 |
+ |
33.0 |
392 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
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