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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- 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:
- Thirteen-week subchronic rat inhalation toxicity study with a recovery phase of trivalent chromium compounds, chromic oxide, and basic chromium sulfate
- Author:
- Derelanko MJ, Rinehart WE, Hilaski RJ, Thompson RB, Loser E
- Year:
- 1 999
- Bibliographic source:
- Toxicological Sciences 52: 278-288
Materials and methods
- Principles of method if other than guideline:
- Fertility was assessed by measuring sperm parameters during a 90-day inhalation study. The study was performed according to OECD TG 413.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Chromium (III) oxide
- EC Number:
- 215-160-9
- EC Name:
- Chromium (III) oxide
- Cas Number:
- 1308-38-9
- Molecular formula:
- Cr2O3
1
Test animals
- Species:
- rat
- Strain:
- other: DCF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female CDF (Fischer 344)/Crl BR VAF/Plus rats, approximately 5 weeks of age, were obtained from Charles River Laboratories (Raleigh, NC).
Following 3 days of group housing, animals were individually housed in stainless steel, suspended wire-mesh cages and given free access to commercial laboratory feed (Purina Certified Rodent Chow No. 5002) and tap water during the non-exposure periods.
Animal rooms were maintained on a 12-h light/dark cycle; temperature range was maintained at 21 ±2°C, and the relative humidity range was 43 ±11%.
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure (if applicable):
- nose only
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Rats were exposed in stainless steel and acrylic nose-only inhalation chambers operated with at least 12 chamber air changes per h.
- Details on mating procedure:
- Not applicable
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Basic chromium sulfate particles were generated using an auger dust feeder and an air micronizer. Chamber samples were determined once per h by standard gravimetric methods, with periodic analysis for Cr(III) and Cr(VI). Particle-size measurements were made from each exposure level using a cascade impactor once per day for the first two weeks and weekly thereafter.
- Duration of treatment / exposure:
- 6 hours/day
- Frequency of treatment:
- 5 days/week
- Details on study schedule:
- Doses basic chromium sulfate (17, 54, or 168 mg/m 3 ). The desired exposure levels were selected to be multiples of the threshold limit value (TLV) for trivalent chromium and set at chromium equivalents of 3, 10, and 30 mg/m3 for each test article.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 17 mg/m³ air (analytical)
- Dose / conc.:
- 54 mg/m³ air (analytical)
- Dose / conc.:
- 168 mg/m³ air (analytical)
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent no treatment
Examinations
- Parental animals: Observations and examinations:
- Performed according to OECD TG 413
- Oestrous cyclicity (parental animals):
- Not applicable
- Sperm parameters (parental animals):
- In a 13-week nose-only inhalation study, sperm samples from male rats were collected at necropsy and were used for automated evaluation of sperm motility, count and morphology.
Sperm evaluation: At necropsy, sperm samples from the left caudal epididymis of 10 males per group were used for automated evaluation of sperm motility, count, and morphology. The concentration and morphology of the sperm were evaluated using visual methods. Two hundred intact sperm were evaluated from each animal for morphology. Intact sperm were evaluated as normal or abnormal. The number of disarticulated sperm in each field was also assessed. - Litter observations:
- Not applicable
- Postmortem examinations (parental animals):
- Performed according to OECD TG 413
- Postmortem examinations (offspring):
- Not applicable
- Statistics:
- one-way analysis of variance
Bartlett’s test for homogeneity of variance
Dunnett’s t-test
Welch t-test with Bonferonni correction
Kruskal-Wallis analysis of variance
Mann-Whitney U test
level for statistical significance: p<0.05
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced mean body weights in mid- and high dose group
- 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
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Chronic inflammation was observed involving the alveoli of all exposure-level groups, consisting of alveolar spaces filled with macrophages, neutrophils, lymphocytes, and cellular debris.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- not examined
Effect levels (P0)
- Dose descriptor:
- NOAEC
- Effect level:
- > 168 mg/m³ air (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: No effects observed at the highest dose level
- Remarks on result:
- other: For CrIII the NOAEC is >30 mg/m3
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
Effect levels (F1)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Sperm motility or morphology was not affected in rats with nose-only exposures to chromium hydroxide sulphate dust at 17, 54, or 168 mg/m3 for 6 h/day, 5 days/week for 13 weeks. Ovary and testes weights were also unaffected by treatment.
Applicant's summary and conclusion
- Conclusions:
- Negative, no effects on sperm parameters and reproductive organ weights.
- Executive summary:
Sperm parameters were assessed in male rats exposed to chromium (III) oxide and chromium (III) hydroxy sulfate in a 90-day inhalation (concentrations of 0, 17, 54 or 168 mg/m3). No treatment-related effects on fertility parameters (sperm parameters) were observed.
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