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EC number: 215-158-8 | CAS number: 1308-14-1
- 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.
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.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- As with all inorganic salts, the significance for toxicity or environmental assessment is the presence of specific ions that will form when in solution or when in biological systems.In the case of Cr III salts, the counter ion will have an effect on solubility and this is itself dependant on the type of media being used and in particular the pH of that media. It is generally accepted that in the case of metal salts, testing with salts that are soluble in the respective test media will ensure maximum exposure of the metal ions. This will include chlorides and nitrates as being more soluble and will indeed have relevance when dissolved in acid media, such as if ingested.Read-across to other chromium III salts is therefore considered valid as long as the exposure in the test system is greater than wold be expected for the substance under review for registration.
- Qualifier:
- no guideline followed
- Version / remarks:
- Standard principles of research, but not following specific guidelines
- Principles of method if other than guideline:
- Males rats were treated with tolerated doses of Chromium (III) chloride and potassium chromate (VI) at 1000 mg/l in drinking water. A reduced body weight suggested this was the maximum tolerated, but clearly some impact on health. Males were mated and numbers of matings observed. Viability of the foeti were assessed with number of implantations and resorptions. Small numbers of animals in this screening study make statistical analysis uncertain.
- GLP compliance:
- no
- Limit test:
- yes
- Justification for study design:
- Research to compare Cr III and Cr VI at tolerated daily doses.
- Specific details on test material used for the study:
- Chromium chloride (Trivalent chromium compound: Janssen Chinica, B-2440 Geel, Belgium),
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were maintained under controlled temperature of 21 f 1°C in 12 h light: 12 h darkness schedule (lights 06.00 - 18.00 h) in cages containing four or five animals. Food and tap water were freely available in the home cage.Male rats were provided access to drinking water containing the test substances for 12 weeks
- Route of administration:
- oral: drinking water
- Details on mating procedure:
- Male rats were presented with a female of the same strain, brought into estrus by sequential subcutaneous treatment with 12.5 pg/animal estradiol benzoate
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Male rats were provided access to drinking water containing the test substances for 12 weeks
- Dose / conc.:
- 1 000 mg/L drinking water
- Remarks:
- Cr(Cl)3 hydrate
- Dose / conc.:
- 24 mg/kg bw/day (nominal)
- Remarks:
- Expressed as Cr3+
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- Equivalent Cr(OH)3
- No. of animals per sex per dose:
- 13 Control15 Treated
- Control animals:
- yes, concurrent no treatment
- Positive control:
- No
- Parental animals: Observations and examinations:
- All males were sacrificed after 12 weeks of exposure. Body weight and weights of paired testes, seminal vesicles (stripped of fluid) and preputial glands were recorded.
- Sperm parameters (parental animals):
- No
- Litter observations:
- No
- Postmortem examinations (parental animals):
- Not applicable
- Postmortem examinations (offspring):
- No
- Statistics:
- Chi - square test or Student’s “t” test
- Reproductive indices:
- Fertility
- Offspring viability indices:
- Not applicable
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced weight gain / weight loss.Reduced feeding observed.Reduced agression
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower weights in treated group, but vigour apparently no affectedReduced agression
- Food consumption and compound intake (if feeding study):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced agression
- Reproductive function: oestrous cycle:
- not examined
- Description (incidence and severity):
- Females were induced into oestrus cycle
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced ejaculations, but similar number attempted matings. This was considered most likely linked to reduced vigour reflected by clinical signs of reduced activitiy
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/L drinking water
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 24 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- Cr3+
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- Clinical signs:
- not examined
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/L drinking water
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- The results presented in this publication suggest that neither trivalent chromium (chromium chloride) or hexavalent chromium compound (potassiumdichromate) had effect on fertility of the male rat.The results showed mixed results with some parameters such as viablity of implants possibles 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.Pre-mating dose of 12 weeks is longer than normally used in guideline methods.
- Executive summary:
Males rats were treated with tolerated doses of Chromium (III) chloride and potassium chromate (VI) at 1000 mg/l in drinking water. A reduced body weight suggested this was maximum tolerated. Males were mated and numbers of matings observed. Viability of the foeti were assessed with number of implantations and resorptions. Small numbers of animals in this screening study make statistical analysis uncertain.
Reference
The results showed mixed results with some parameters such as viablity of implants possibles 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.
Pre-mating dose of 12 weeks is longer than normally used in guideline methods.
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.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Treatment of females gestation days 6 - 17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Study performed on soluble chromium III salt used as a food supplement and cited in reviews on safety of such food supplements.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- From gestation days (GD) 6–17, mated CD-1 female mice were fed diets delivering either 25mg Cr/kg/day as Cr(pic)3, 3.3 or 26mg Cr/kg/day as Cr3 propionate, or the diet only to determine if Cr3 could cause developmental toxicity. Dams were sacrificed on GD 17, and their litters were examined for adverse effects
- GLP compliance:
- no
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- Male and female CD-1 mice, obtained from Charles River Breeding Laboratories, International (Wilmington, MA) Housed at ca 22C, with 40–60% humidity and a 12-hr photoperiod
- Route of administration:
- oral: feed
- Details on exposure:
- Females were given treated diets containing ca 25 mg/kg/day Cr III as either picolinate or as propionate from gestation days 6 - 17
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Animals were bred naturally, two females with one male. Observation of a copulation plug was designated GD 0.
- Duration of treatment / exposure:
- Females were given treated diets containing ca 25 mg/kg/day Cr III as either picolinate or as propionate from gestation days 6 - 17
- Frequency of treatment:
- Diet
- Duration of test:
- 12 days
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Remarks:
- Expressed as Cr III either dosed as picolinate or propionate
- Dose / conc.:
- 3.3 mg/kg bw/day (nominal)
- Remarks:
- Expressed as Cr III dosed as propionate
- No. of animals per sex per dose:
- Up to 30 females per group.
- Control animals:
- yes, plain diet
- Maternal examinations:
- Clinical signs, weight, food consumption
- Ovaries and uterine content:
- Implantations
- Fetal examinations:
- Foetal weight, viability, skeletal and other defects
- 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):
- no effects observed
- Description (incidence and severity):
- Food consumption was virtually identical among the treatment groups, and average food consumption was approximately 7g diet/day.
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- Percentage of resorbed or dead fetuses did not differ among treatment groups
- Details on maternal toxic effects:
- NoneMaternal weight gain was not affected by the administration of Cr(pic)3 or Cr3 (Table 1). No signs of maternal toxicity were observed for dams in any of the groups
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 25 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Fetal weight and percentage of resorbed or dead fetuses did not differ among treatment groups
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- No skeletal defects in fetuses from Cr(pic)3- or Cr3-treated dams differed in incidence from the control value.
- Visceral malformations:
- not specified
- Other effects:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 25 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- No signs of maternal toxicity were observed.No decrease in foetal weight or significantly increased incidence of skeletal defects was observed compared to the controlsAlthough exposure was not up to the maternal tolerated limit and the exposure period was relatively short, there were no adverse effects observed.
Reference
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.