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Diss Factsheets
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EC number: 915-035-5 | 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
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across to chromium(III) chloride. This salt is more soluble than trichromium dicarbide, and therefore the results obtained with this substance can be regarded as "worst case" situations also for chromium carbide exposure. Acceptable, well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Exposure of pregnant mice to chromium picolinate results in skeletal defects in their offspring.
- Author:
- Bailey, M. M., J. G. Boohaker, et al.
- Year:
- 2 006
- Bibliographic source:
- Birth Defects Res B Dev Reprod Toxicol.77(3): 244-9.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Pregnant CD-1 mice were fed diets containing chromium chloride (200 mg/ kg bodyweight / day) during gestation days 6-17. Dams were sacrificed on GD 17, and their litters were examined for adverse effects.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- chromium(III) chloride
- IUPAC Name:
- chromium(III) chloride
- Details on test material:
- Chromium chloride (CrCl3) obtained from Fischer Scientific (Pittsburgh, PA, USA). No other details given.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CD-1 mice from Charles River Breeding Laboratories, International (Wilmington, MA, USA)
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: mated females housed individually in shoe-box type cages with hardwood bedding
- Diet (e.g. ad libitum): Milled rodent diet from Harlan Teklad (Madison, WI, USA) ad libitum
- Water (e.g. ad libitum): yes, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: AAAlAC-approved animal facility
- Temperature (°C): 22 ± 2 C
- Humidity (%): 40-60%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
-
DIET PREPARATION
- Rate of preparation of diet (frequency): no data. Stability studies indicate that chromium compounds are extremely stable and no degradation in the diet would be expected.
- Mixing appropriate amounts with (Type of food): Milled rodent diet
- Storage temperature of food: no data - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Calculations based on data from previous studies indicating that pregnant CD-1 mice consume an average of 7 g diet/day.
- Details on mating procedure:
- - Animals were bred naturally, two females with one male.
- Proof of pregnancy: [vaginal plug ] referred to as [day 0] of pregnancy - Duration of treatment / exposure:
- 12 days (during gestation days 6-17)
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200 mg/kg bw/day (=39 mg Cr(3+))
Basis:
nominal in diet
- No. of animals per sex per dose:
- 14
- Control animals:
- yes, plain diet
- Details on study design:
- Random assignment into groups.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: no data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 17
- Organs examined: uterus weight
OTHER: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: - Fetal examinations:
- External examinations: Yes: [all per litter ] (live fetuses examined for gross malformations)
- Soft tissue examinations: No data
- Skeletal examinations: Yes: [all per litter ]
- Head examinations: No data- Statistics:
- The data from each study replicate were calculated independetly, tested for for homogeneity of variance by the Levene statistic, and then pooled and analyzed together. Data were analyzed either by ANOVA followed by an LSD post-hoc test to determine specific significant differences (P<0.05) pr by a Pearson chi-square test (P<0.05).
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Maternal weight gain was not affected by treatment with CrCl3.No signs of maternal toxicity were observed (no details given).
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 200 mg/kg bw/day (nominal)
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 200 mg/kg bw/day (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The results showed no differences between the foetuses of the CrCl3 group compared with the control group, when assessing foetal weight, percentage of resorbed/dead foetuses, and malformations.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 200 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: Maternal dose 200 mg CrCl3/kg bw/ day. Basis: foetal weight, percentage of dead foetuses
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Maternal treatment with 200 mg chromium chloride/kg bw/day during gestation days 6-17 did not result in any signs of developmental toxicity.
- Executive summary:
The effect of chromium chloride was studied by administering a diet containing 200 mg/kg bw/day CrCl3 during gestation days 6-17 to pregnant CD-1 mice. The results showed no differences between the foetuses of the CrCl3 group compared with the control group, when assessing foetal weight, percentage of resorbed/dead foetuses, and malformations. No signs of maternal toxicity were observed either, a fact which decreases the relevance of the results, as it is quite evident that a higher dose would be need for reaching a level with a potential to cause developmental toxicity.
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