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EC number: 250-317-5 | CAS number: 30737-19-0
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The results presented in various publications (including UN CICAD and European Food Scientific Committe on Food are used) suggest that trivalent chromium has no effect on fertility at tolerated levels of exposure.
The results of work with high doses showed mixed results with some parameters such as viablity of implants possibly reduced (sample sizes too small for reliable statistics) and reduced mating performance that may be in relation to reduced body weights - ie secondary effects to other adverse parental toxicity.
Ingestion of oxalate as oxalic acid did not cause adverse effects general health, mating or fertility, although there was a significant reduction in water consumption at top dose levels.
Treatment with 162 mg/kg/day resulted in a significant decrease of average number of litters
Adjusted kidney weight increased by nearly 10%in high dose females.
For the second generation, there was a decrease at the high dose level of average number of live pups per litter.
At necropsy, kidney weight was significantly increased by about 10% in high dose males and females.
A no observed adverse effect concentration is considered to be 162 mg/kg/day
Ultimately, it needs to be realised that Cr3+ is an essential element in diet and occurs in food and natural water. It is readily excreted and is non-accumulative. Oxalic acid is a natural metabolite formed in all cells and is excreted in the urine.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- The test was performed on a bio-available salt of chromium III that is commonly used in dietary supplements. The counter ion, picolinate, is itself under checks for possible reproductive effects, but a negative response in this study means that it is good evidence that neight chromium III or picolinate are hazarous for reproduction.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.3800 (Reproduction and Fertility Effects)
- Principles of method if other than guideline:
- Four weeks prior to mating, the males were fed a diet providing 200 mg/kg/day [Cr(pic)3] for comparison with untreated controls. Females were not treated. Each male was mated with two females, which were sacrificed on gestation day 17, and their litters were examined for adverse effects.
- GLP compliance:
- no
- Limit test:
- yes
- Justification for study design:
- Valid assessment method to examine potential effects on fertility.
- Species:
- mouse
- Strain:
- CD-1
- Details on species / strain selection:
- Charles River Breeding Laboratories, International (Wilmington, MA)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 22±2°C, with 40–60% humidity and a 12-h photoperiod
- Route of administration:
- oral: feed
- Details on exposure:
- 200 mg/kg body mass per day (25 mg Cr per kilogram body mass per day) mixed into feed, based on data from previous studies, which indicated that CD-1 mice consume an average of 7 g diet per day
- Details on mating procedure:
- Animals were mated naturally, two females with one male, for 1 week.Observation of a copulation plug in the vagina designated gestation day 0 (GD 0). Mated females were individually housed in shoe box-type cages with hardwood bedding and given Harlan Teklad rodent chow and water ad libitum.
- Details on analytical verification of doses or concentrations:
- Males were fed the appropriate test diet for 4 weeks prior to mating
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- Diet
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- Of the test substance in feed
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Remarks:
- Cr 3+ equivalent
- No. of animals per sex per dose:
- 24 females, 12 males
- Control animals:
- yes, plain diet
- Litter observations:
- Yes
- Reproductive indices:
- Yes
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- The mating indices for control and treated males were identical
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 25 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- Chromium III
- Sex:
- male
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 25 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- Cr3+
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 25 mg/kg bw/day (nominal)
- Conclusions:
- No adverse fertility or developmental effects observed when male mice were treated at 25 mg/kg/day for 4 weeks prior to meting.
- Executive summary:
The test was performed on a bio-available salt of chromium III that is commonly used in dietary supplements. The counter ion, picolinate, is itself under checks for possible reproductive effects, but a negative response in this study means that it is good evidence that neither chromium III or picolinate are hazarous for reproduction.
Reference
An increase in the average number of total resorbed or dead fetuses was observed in the treated group as compared to controls; however, the increase was not statistically significant. No significant effect of exposure was seen on gross or skeletal malformations (split cervical arch) or skeletal variations (rudimentary or supernumerary ribs). Fetuses sired by exposed males weighed significantly more than fetuses of unexposed males. However, this difference is extremely small and is probably a statistical anomaly.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 30 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Expressed as Cr3+ (44 mg/m3 as Cr2O3)
Effects on developmental toxicity
Description of key information
An increase in the average number of total resorbed or dead foeti was observed in the treated group as compared to controls; however, the increase was not statistically significant.
No significant effect of exposure was seen on gross or skeletal malformations or skeletal variations. Foeti sired by exposed males weighed more than those of unexposed males but this finding was considered a statistical anomaly.
Note that both chromium III and oxalic acid salts are found in food. Chromium III is an essential element and oxalic acid is a product of metabolism that is typically excreted.
In view of high concentrations in the diet and in living tissues, the substance is not considered to be toxic for reproduction.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Study duration:
- subacute
- Species:
- mouse
Additional information
No signs of maternal toxicity were observed.
No decrease in foetal weight or significantly increased incidence of skeletal defects was observed compared to the controls
Justification for classification or non-classification
Extract from Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Trivalent Chromium (expressed in 4 April 2003)
Chromium (III) chloride dissolved in tap water was given to sexually mature male and female Swiss mice (day 50 of age). Males received water with 1000 or 5000 mg/L chromium chloride and females with 2000 or 5000 mg/L ad libitum for 12 weeks. Controls were given tap water, only. Treated animals consumed less water per day than controls did. Chromium chloride reduced fertility and seminal vesicle weights significantly. Body weights were reduced in males but not in females. Testes and ovarian weights were increased whereas uterine weights were significantly reduced. The number of resorptions and dead foetuses was increased in females impregnated by males exposed to the trivalent compound and the number of resorptions in exposed females as well (Elbetieha and Al-Hamood, 1997). Unfortunately, the authors did not report the actual quantitative exposure to chromium chloride but EGVM (2002b) estimated from the given data oral doses for trivalent chromium of approximately 500 or 1250 mg/kg bw/day for females and 250 or 1250 mg/kg bw/day for males.
The fertility of male Sprague Dawley rats exposed to chromium (III) chloride in drinking water at a concentration of 1000 mg/L for 12 weeks, which is equivalent to about 50 mg CrCl3/kg body weight or about 16,5 mg trivalent chromium/kg body weight, was unaffected but significant reductions in the weight of testes and seminal vesicles were observed (Bataineh et al., 1997).
There are no reports of developmental toxicity studies on chromium (III) compounds given orally
Additional information
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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