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Diss Factsheets
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EC number: 946-354-8 | CAS number: -
- 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:
- other: read-across from constituent CrIII
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- 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
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 instead of 13 weeks of exposure
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Cr III
- Molecular formula:
- Cr III
- IUPAC Name:
- Cr III
- Details on test material:
- CrCl3.6H2O or CrCl3
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 wk
- Frequency of treatment:
- 1x daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 5 mg/kg bw/day (nominal)
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- as chromium chloride, Daily Cr3+ intakes can be estimated to correspond to 0.35 – 7 mg/kg
- 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 as reported by Anderson et al. (1997). The daily Cr3+ intakes can be estimated to correspond to 0.35 – 7 mg/kg bw using the 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:
- No
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.
- 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:
- no effects observed
- 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). However, no relation with time or dose. In addition effects occur only at specific time points with no general trend.
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
- 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
- Dose descriptor:
- NOAEL
- Effect level:
- > 21.3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- Chromium chloride
- Sex:
- male
- Basis for effect level:
- clinical biochemistry
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Some sporadic, statistically significant changes were seen in some clinical chemistry parameters
Target system / organ toxicity
- Critical effects observed:
- not specified
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 chloride.
- Executive summary:
his 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. No alterations in testes 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 chloride.
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