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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: reliable report in peer reviewed Journal but only secondary literature available
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
- Reference Type:
- publication
- Title:
- Chromium as an essential nutrient for humans
- Author:
- Anderson RA
- Year:
- 1 997
- Bibliographic source:
- Regulatory Toxicology and Pharmacology, 26:S35–41, 1997
- Reference Type:
- review article or handbook
- Title:
- Concise International Chemical Assessment Document 76 INORGANIC CHROMIUM(III) COMPOUNDS
- Author:
- Dr Tiina Santonen, Dr Antti Zitting, and Dr Vesa Riihimäki
- Year:
- 2 009
- Bibliographic source:
- International Programme on Chemical Safety (IPCS)
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:
- 20 weeks of exposure rather than only 13 weeks
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Chromium trichloride
- EC Number:
- 233-038-3
- EC Name:
- Chromium trichloride
- Cas Number:
- 10025-73-7
- Molecular formula:
- Cl3Cr
- IUPAC Name:
- chromium trichloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Reagent grade chromic chloride was purchased from Fisher Scientific Co. (Pittsburgh, PA)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Four-week-old male Harlan Sprague-Dawley rats (eight per group)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on oral exposure:
- CrCl3 was fed a diet supplemented with 0, 5, 25, 50, or 100 mg Cr/kg as chromium chloride for a period of 20 weeks.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 20 weeks
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, 25, 50, or 100 mg Cr/kg as chromium chloride, Daily Cr3+ intakes can be estimated to correspond to 0.35 – 7 mg/kg
Basis:
nominal in diet
- No. of animals per sex per dose:
- 8
- Control animals:
- yes, plain diet
- Details on study design:
- Four-week-old male Harlan Sprague-Dawley rats (eight per group) were fed a diet supplemented with 0, 5, 25, 50, or 100 mg Cr/kg as chromium chloride for a period of 20 weeks (Anderson et al., 1997). Daily Cr3+ intakes can be estimated to correspond to 0.35 – 7 mg/kg bw (estimated on the basis of default reference values given in Appendix VI of European Commission [2003]). If 200 g is used as a mean body weight, the highest dose corresponds to 7 mg chromium/kg bw (corresponds to 21.3 mg CrCl3/kg bw).
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- Effects on body weights, selected organ weights, and the histology of liver and kidneys were evaluated.
- Sacrifice and pathology:
- Histopathological examination was performed on four high-dose and four control rats. Haematology and biochemical analyses of blood (serum glucose, cholesterol, triglycerides, liver enzymes, blood urea nitrogen, total protein, and creatinine) were performed on animals at 11, 17, and 24 weeks of age.
- Other examinations:
- Blood was collected from the tail after ll and l7 weeks and following decapitation after 24 weeks, allowed to clot 30 minutes at room temperature and then stored on ice prior to centrifugation at 4000 g for 30 minutes. Serum glucose, cholesterol, triglycerides, blood urea nitrogen, total protein, creatinine, .actate dehydrogenase, alanine amino transferase and aspartate amino transferase were determined using standard laboratory procedures on a Centrifichem 600 (Baker Instruments, Allentown, PA).
- Statistics:
- Statistical analyses of the data were performed by analysis of variance. Individual mean comparisons were identified with Duncan’s multiple range test. All values are mean ± SEM. There were eight animals per group. Using eight rats per group would be sufficient to detect a difference at the 0.05 level (power 0.9) with an expected difference between means of 0.4 and a standard deviation of 0.2 .
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Some sporadic, statistically significant changes were seen in some clinical chemistry parameters (lactate dehydrogenase, aspartate aminotransferase, serum creatinine levels), but no obvious effect on chromium concentration was stated by the authors.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- No changes compared to control in body weights were observed in any dose group and all animals appeared normal with no visible differences amongst the groups. Weights of heart, liver, kidney, spleen, pancreas, testes and epididymal fat pad were not altered by dietary Cr. Hematocrit was also similar among all the groups. No changes in body or organ weights, no general signs of toxicity, and no changes in liver or kidney histopathology were seen. Some sporadic, statistically significant changes were seen in some clinical chemistry parameters (lactate dehydrogenase, aspartate aminotransferase, serum creatinine levels), but because these changes did not show any dose or time dependency, they were not considered to be treatment related. Glucose, cholesterol and triglycerides were similar for all groups at 11, 17 and 24 weeks.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 7 mg/kg bw/day (actual dose received)
- Based on:
- element
- Remarks:
- chromium
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Effect level:
- > 21.3 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- chromium chloride (anhydrous)
- Sex:
- male
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Chromium concentrations in liver and kidneys were determined in four rats per group, showing a linear increase of chromium in liver and kidney tissue with doses received. Chromium picolinate resulted in significantly higher chromium concentrations in livers and kidneys, indicative of higher absorbtion rates compared to chromium trichloride. Values for Cr picolinate animals were consistently several-fold
higher than respective values for the Cr chloride supplemented animals.
Applicant's summary and conclusion
- Conclusions:
- Based on these results, the highest dose level (7 mg chromium (III)/kg bw/day ) can be considered as a no-observed-adverse-effect level (NOAEL) for repeated dose toxicity (using 200 g as a mean body weight). Accordingly, this relates to a NOAEL of 21.3 mg/kg bw/d based on chromium trichloride.
- Executive summary:
This study was conducted to evaluate the toxicity of chromium chloride in rats exposed to 0, 5, 25, 50, or 100 mg Cr/kg chromium trichloride in the diet for 20 weeks (estimated to correspond to 0.35 – 7 mg/kg bw). No morphological changes of liver and renal damage were observed based on histopathological examination of kidneys and did not result in significant alterations in body weight gain at level of 15 mg chromium (III)/kg bw/day. However, in calculations, they used a rat body weight of only 100 g, which seems exceptionally low, because the normal weight of adult Sprague-Dawley rats is between 200 and 300 g. If 200 g is used as a mean body weight, the highest dose corresponds to 7 mg chromium/kg bw. Moreover no alterations in testers or epididymis weights were observed in rats at the highest dose.
Therefore, the no-observed-adverse-effects-level (NOAEL) of chromium trichloride is estimated to be 7 mg chromium (III)/kg bw/day. This value can be converted to a NOAEL of 21.3 mg/kg bw/d based on molecular mass of chromium trichloride (anhydrous) or to 35.9 mg chromium trichloride hexahydrate/kg bw/d respectively.
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