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Diss Factsheets
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EC number: 213-909-4 | CAS number: 1066-30-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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: Comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Absence of toxic effects in F344/N rats and B6C3F1 mice following subchronic administration of chromium picolinate monohydrate.
- Author:
- Rhodes, M.C. et al.
- Year:
- 2 005
- Bibliographic source:
- Food and Chemical Toxicology 43, 21-29
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- limited measurements and examinations
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 27882-76-4
- Cas Number:
- 27882-76-4
- IUPAC Name:
- 27882-76-4
- Reference substance name:
- Chromium picolinate monohydrate
- IUPAC Name:
- Chromium picolinate monohydrate
- Details on test material:
- - Name of test material (as cited in study report): Chromium picolinate monohydrate, TCI America
- Analytical purity: 99%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Laboratory Animals and Services
- Age at study initiation: 6 weeks
- Weight at study initiation: 92 g (male), 93 g (female)
- Housing: 5 per cage
- Acclimation period: 11 - 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 - 23.9
- Humidity (%): 35 - 65
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet (irradiated NTP-2000 open formula diet)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): four times throughout the study
- Storage temperature of food: room temperature, protected from light (stability of the test substance under these conditions was at least 42 days) - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 93 days
- Frequency of treatment:
- ad libitum
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
80; 240; 2000; 10,000 or 50,000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
7, 19, 160, 805 and 4243 mg/kg bw (males)
Basis:
other: average daily doses
- Remarks:
- Doses / Concentrations:
6, 19, 162, 780 and 4254 mg/kg bw (females)
Basis:
other: average daily doses
- No. of animals per sex per dose:
- 10 in core study and 10 per sex and dose and time point in special study (hematology and clinical chemistry analyses on days 3 and 21)
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: day 1, weekly throughout the study and at sacrifice
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No, food consumption was measured by cage covering a 7-day period
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on days 3, 21 and 93 (terminal sacrifice)
- Anaesthetic used for blood collection: Yes, CO2/O2
- Animals fasted: No data
- How many animals: 10
- Parameters checked: erythrocyte count, hemoglobin, packed cell volume, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, reticulocyte count, nucleated red blood cell count, total leukocyte count, differential leukocyte counts, red blood cell morphology and platelet morphology
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on days 3, 21 and 93 (terminal sacrifice)
- Animals fasted: No data
- How many animals: 10
- Parameters checked: sorbitol dehydrogenase, alkaline phosphatase, creatine kinase, creatinine, total protein, albumin, blood urea nitrogen, total bile acids and alanine aminotransferase
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ weights of liver, right kidney, heart, lungs, thymus and right testis
HISTOPATHOLOGY: Yes
complete (no further details given) - Statistics:
- analysis of variance followed by the parametric multiple comparison procedures of Dunnett and Williams (organ and body weight), Kruskal-Wallis analysis of variance (hematology and clinical chemistry), Jonckheere's test (dose-response analysis), Cochran-Armitage and Fisher's exact test (prevalence of nonneoplastic lesions)
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 2 015 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects NOAEL converted from the tri-picolinate monohydrate to the basic acetate monohydrate
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No deaths occured.
No significant compound-related affects on body weight, body weight gain and food consumption were observed.
Administration of the test substance did not produce clinical signs of toxicity. However, the feces of high dose animals had a reddish colour, probably because of the reddish-colour of the test substance.
There were no statistically significant hematological and clinical chemistry changes observed.
Absolute organ weights showed slight alterations in exposed animals. Male heart and liver weights showed negative trends (not dose-related, 9% less than controls in high dose group). Female right kidney weights were significantyl increased in all dosed animals (up to 12% greater than controls). These effects were, however, not considered treatment-related.
Histopathological lesions were considered spontaneous or incidental and not related to the test substance.
Effects on reproduction are described in section 7.8.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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