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EC number: 233-038-3 | CAS number: 10025-73-7
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline comparable, published study
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of the Potential for Developmental Toxicity of Prenatal Exposure to Two Dietary Chromium Supplements, Chromium Picolinate and [Cr3O(O2CCH2CH3)6(H2O)3]+, in Mice
- Author:
- Bailey MM, Sturdivant J, Jernigan PL, Townsend MB, Bushman J, Ankareddi I, Rasco JF, Hood RD & Vincent JB
- Year:
- 2 008
- Bibliographic source:
- Birth Defects Research (Part B) 83:27–31
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Method broadly comparable to OECD 414, performed in the mouse using dietary administration
- GLP compliance:
- no
- Remarks:
- : published study
- Limit test:
- no
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 and Cr3 ([Cr3O(O2CCH2CH3)6(H2O)3]+)
- IUPAC Name:
- Chromium picolinate and Cr3 ([Cr3O(O2CCH2CH3)6(H2O)3]+)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- The study was performed using the water soluble complexes of Cr (III) chromium picolinate and [Cr3O(O2CCH2CH3)6(H2O)3]+ (Cr3)
Chromium(III) picolinate, was synthesised according to the methods of Press et al (1990). Cr3 was synthesised according to the methods of Earnshaw et al (1966). The authenticity of both was established by high resolution electron impact mass spectrometry. Picolinic acid was purchased from Fisher Scientific (Pittsburgh, PA). LM-485 milled rodent diet was purchased from Harlan Teklad (Madison, WI). Either Cr(pic)3 or Cr3 was added to milled rodent chow in sufficient quantities to achieve the appropriate concentration of the test compound. All calculations were based on data from previous studies, which indicated that pregnant CD-1 mice consume an average of 7 g diet/day. Extensive stability studies indicate that chromium test compounds are extremely stable and that no degradation in the diet would be expected. Because the purpose of this study was to determine the effects of pharmaceutical levels of chromium, no special measures were taken to prevent exposure of the mice to small amounts of chromium that may be introduced into the diet through methods of feed preparation or from the cage hardware. The diet purchased, Teklad LM-485 (7012), contained added chromium in the form of chromium potassium sulphate (0.48 mg/kg of diet).
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CD-1
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Male and female CD-1 mice, obtained from Charles River Breeding Laboratories, International (Wilmington, MA) were housed in an AAALAC-approved animal facility in rooms maintained at 22721C, with 40–60% humidity and a 12-hr photoperiod. Animals were bred naturally, two females with one male. Observation of a copulation plug was designated GD 0. Mated females were individually housed in shoe-box-type cages with hardwood bedding and were given Harlan-Teklad LM-485 rodent diet and tap water ad libitum.
- Duration of treatment / exposure:
- Females were exposed from Gestation Day 6-17
- Frequency of treatment:
- Continuous (dietary)
- Duration of test:
- Maternal animals were sacrificed on Gestation Day 17.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
Control
Basis:
other: untreated diet
- Remarks:
- Doses / Concentrations:
200 mg/kg bw/d chromium picolinate
Basis:
other: based on predicted food consumption
- Remarks:
- Doses / Concentrations:
15 mg/kg bw/d Cr3
Basis:
other: based on predicted food consumption
- Remarks:
- Doses / Concentrations:
120 mg/kg bw/d Cr3
Basis:
other: based on predicted food consumption
- No. of animals per sex per dose:
- Not stated, however the numbers of litters in each group range from 24-29
- Control animals:
- yes, plain diet
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 26 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- chromium III
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 26 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- chromium III
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No signs of maternal toxicity were observed.
Mean foetal weights, foetal viability and the proportion of resorptions were unaffected by treatment. No gross malformations were observed in any of the foetuses. The number of implantations in the low dose Cr3 group was lower than the other treated groups, however this is not considered to be an effect of treatment in the absence of a dose-response relationship and because implantation occurred prior to exposure. No effects of treatment were observed on the incidence of skeletal anomalies. The authors note that a previous study (Bailey et al, 2006) reported an increased incidence of cervical arch defects in the offspring of mice exposed to chromium picolinate, however the incidence of defects in that study (6.26%) is very similar to the control incidence in this study (5.79% and is therefore not considered to be related to treatment.
Summary of findings
Parameter |
Dose group |
||||
0 |
Cr picolinate |
Cr3 (low) |
Cr3 (high) |
||
Litters |
(#) |
27 |
29 |
26 |
24 |
Foetuses |
(#) |
332 |
369 |
275 |
342 |
Litter size |
(#) |
12.30 |
12.72 |
10.58 |
14.25 |
Foetal weight |
(g) |
1.02 |
1.05 |
1.08 |
1.02 |
Implantations |
(#) |
12.64 |
13.18 |
11.00 |
13.79 |
Dead/resorbed foetuses |
(#) |
2.74 |
3.29 |
3.48 |
1.29 |
Cervical arch defects |
(#) |
4.65 |
6.26 |
5.18 |
3.98 |
Cervical arch defects refer to a distal split in the first or second cervical vertebral arch
Applicant's summary and conclusion
- Conclusions:
- No evidence of foetotoxicity, developmental toxicity or teratogenicity was seen in mice exposed to water-soluble complexes of Cr(III) delivering estimated daily doses of Cr(III) equivalent to 25 mg/kg bw/d (picolinate group), 3.3 mg/kg bw/d (low dose Cr3 group) and 26 mg/kg bw.d (high dose Cr3 group).
- Executive summary:
Mated female mice were administered Cr(III) in the diet from Days 6 -17 of gestation. Dams were sacrificed on Day 17 and the uterine contents investigated. Foetuses were assessed for external defects and skeletal findings following double staining. No maternal toxicity was observed. No evidence of teratogenicity, foetotoxicity or developmental toxicity was seen. The results of this study also show that a reported increased incidence of cervical arch defects in a previous study by the same authors was within the background range.
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