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EC number: 254-447-3 | CAS number: 39430-51-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- 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: GLP study according to modern scientific standards, minor deviations from applicable guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Chromium picolinate monohydrate
- IUPAC Name:
- Chromium picolinate monohydrate
- Reference substance name:
- 27882-76-4
- Cas Number:
- 27882-76-4
- IUPAC Name:
- 27882-76-4
- Details on test material:
- - Name of test material (as cited in study report): Chromium Picolinate Monohydrate
- Molecular formula (if other than submission substance): Cr(C5H4NCO2) x H2O
- Molecular weight (if other than submission substance): 436.6 g/mol
- Smiles notation (if other than submission substance): O.O=C(O[Cr](OC(=O)c1ccccn1)OC(=O)c2ccccn2)c3ccccn3
- Physical state: reddish-purple crystalline powder
- Lot/batch No.: NG0569
Constituent 1
Constituent 2
- Radiolabelling:
- yes
- Remarks:
- 14C-labelling of the picolinate anion
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc. (Raleigh, NC, USA)
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 200-230 g
- Housing: polycarbonate cages
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): Certified Purina Rodent Chow #5002 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 1 week
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): the test material was administered in propylene glycol as well as in water - Duration and frequency of treatment / exposure:
- Single adminsitration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
15.3 mg/kg bw (propylene gylcol)
17.4 mg/kg bw (as an aqueous slurry)
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: adipose (two sites), bladder, blood, brain, heart, kidney, liver, lung, muscle (two sites), skin (ear), spleen, testis, stomach (with contents), small intestine (with contents), large intestine (with contents), and cecum (with contents).
- Time and frequency of sampling: Urine and feces were collected until excretion was essentially complete (52 hours) and analyzed for total radiolabel by LSS and chromium by the method described below. Exhaled organic volatiles and CO2 were collected for 24 and 48 hours, respectively. The animals were sacrificed at 52 hours postdosing.
- Other: Aliquots of urine and feces from animals receiving [14C]-chromium picolinate were analyzed for total chromium. The fecal samples were prepared for analysis as described above. The resulting solutions were analyzed for chromium using a PerkinElmer Optima 4300 DV inductively coupled plasma-atomic emission spectrometer.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- 1.3-1.5%, judging from urinary excretion
- Details on distribution in tissues:
- see tissue distribution study
- Details on excretion:
- Propylene glycol: An average of 1.25% ± 0.24% and 97.5% ± 7.4% of the chromium dose was excreted in urine and feces, respectively, in 48 hours.
Aqueous slurry: An average of 1.53% ± 0.51% and 97.6% ± 7.4% of the chromium dose was excreted in urine and feces, respectively, in 48 hours.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Cr(III) is not metabolised. The metabolism of the picolinate ion was investigated, but the anion is out of the scope for this dossier.
The analysis of urine revealed that about 1% of the administered chromium picolinate is excreted unchanged in the urine of rats. Analysis of blood 1 hour following a 17.4 mg/kg oral dose indicated a concentration of 31 ng chromium picolinate/g of blood (data not shown). At this same time the total radioactivity in blood was 290 ng-Eq of chromium picolinate, so no more than 10% of the chromium in the blood was associated with picolinate.
Any other information on results incl. tables
15.3 mg/kg Oral Dose of [14C]-Chromium Picolinate in Propylene Glycol to Rats
The results of the assay of total chromium excreted in urine and feces collected from the animals are shown in Table 1. An average of 1.25% ± 0.24% and 97.5% ± 7.4% of the chromium dose was excreted in urine and feces, respectively, in 48 hours.
17.4 mg/kg Oral Dose of [14C]-Chromium Picolinate to Rats as an Aqueous Slurry
Excretion of total chromium from rats sacrificed at 48 hours following administration of chromium picolinate is also shown in Table 1. An average of 1.53% ± 0.51% and 97.6% ± 7.4% of the chromium dose was excreted in urine and feces, respectively, in 48 hours.
Table 1: Excretion of Total Chromium by Male Rats |
|||
Time (hours) |
Urine |
Faeces |
Total |
|
|||
8 |
0.97 ± 0.26 |
— |
0.97 ± 0.26 |
24 |
1.18 ± 0.24 |
82.5 ± 12.2 |
83.7 ± 12.1 |
48 |
1.25 ± 0.24 |
97.5 ± 7.4 |
98.8 ± 7.3 |
|
|||
2 |
0.16 ± 0.14 |
— |
0.18 ± 0.14 |
4 |
0.34 ± 0.04 |
0.0 ± 0.0 |
0.34 ± 0.04 |
8 |
0.66 ± 0.05 |
7.64 ± 15.3 |
8.30 ± 15.3 |
12 |
0.84 ± 0.05 |
13.7 ± 11.5 |
14.6 ± 11.5 |
24 |
1.16 ± 0.34 |
92.9 ± 8.9 |
94.1 ± 8.8 |
48 |
1.53 ± 0.51 |
97.6 ± 7.4 |
99.2 ± 7.2 |
a Values are presented as cumulative percent of dose (mean ± standard) deviation for four rats at each timepoint. |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Poor absorption. Complete excretion within 48 h, almost quantitatively in faeces. Comparing total chromium excreted in urine following dosing with either the solution or slurry reveals little difference in rats. - Executive summary:
The poor bioavailability of chromium III, even though it is an essential mineral, is well known. The poor bioavailability is little improved when chromium is complexed with picolinic acid or similar complexing agents.
Chromium picolinate has low water solubility. The rate of dissolution of the solid complex could be slow enough to affect bioavailability. One of the goals of these studies was to establish the effect of formulation on bioavailability. Propylene glycol was found to be a good solvent for the complex allowing comparison of bioavailability of a homogenous formulation to an aqueous slurry. Comparing total chromium excreted in urine following dosing with either the solution or slurry reveals little difference in rats.
A second question these studies sought to answer was the form of chromium in circulation. The analysis of urine revealed that about 1% of the administered chromium picolinate is excreted unchanged in the urine of rats.
Analysis of blood 1 hour following a 17.4 mg/kg oral dose indicated a concentration of 31 ng chromium picolinate/g of blood (data not shown). At this same time the total radioactivity in blood was 290 ng-Eq of chromium picolinate, so no more than 10% of the chromium in the blood was associated with picolinate.
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