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Registration Dossier
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Diss Factsheets
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EC number: 232-051-1 | CAS number: 7784-18-1
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- Deviations:
- not applicable
- Remarks:
- -no deviations were cited in the EU risk assessment
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Trisodium hexafluoroaluminate
- EC Number:
- 237-410-6
- EC Name:
- Trisodium hexafluoroaluminate
- Cas Number:
- 13775-53-6
- IUPAC Name:
- 13775-53-6
- Reference substance name:
- Trisodium hexafluoroaluminate
- IUPAC Name:
- Trisodium hexafluoroaluminate
- Details on test material:
- - Name of test material (as cited in study report): Cryolite
- Physical state: Not reported
- Analytical purity: 97.3 to 97.4%
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
Constituent 1
Constituent 2
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-No other information available.
ENVIRONMENTAL CONDITIONS
-No other information available.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
-No other information available.
DIET PREPARATION
-No other information available.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- -No other information available.
- Duration of treatment / exposure:
- 1 year
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 105, 387, or 1139 mg/kg bw/day (females)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
0, 95, 366, 1137 mg/kg bw/day (males)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
0, 3000, 10000, or 30000 ppm (males and females)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 4/sex/group
- Control animals:
- yes, plain diet
- Details on study design:
- -No other information available.
- Positive control:
- None used.
Examinations
- Observations and examinations performed and frequency:
- No other information available; however, clinical signs, body weight gain, hematology, clinical chemistry, and microscopic examination were conducted.
- Sacrifice and pathology:
- GROSS PATHOLOGY: No data
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- 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:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- In the animals administered 3000 ppm cryolite, slight increases in the incidence of emesis in both males and females (vomiting, white and yellow froth) were reported. Body weight gain was increased in males in the 30000 ppm dose group.
Haematology analysis revealed nucleated red cells in males receiving 3000 ppm cryolite; decreased red cell count, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, and platelets; and an increased incidence of specific alterations of red blood cell morphology (anisokaryocytes, microcytes, macrocytes, target cells, hypochromic cells, nucleated red cells, basophilic strippling, and Howell-Jolly bodies) in both males and females in the 10000 ppm dose group, and increased leukocytes (primarily segmented neutrophils and eosionphils) were observed only in females.
Based on clinical chemistry parameters, a decrease in total serum protein and calcium in males and in serum albumin in females were noted at the 10000 ppm dose group. Increased lactate dehydrogenase was determined in both males and females, and decreased blood sodium was observed in males in the 30000 ppm dose group. In females receiving 3000 ppm a decrease in specific gravity of the urine was seen. Following microscopic examination, renal lesions such as regeneration of the tubular epithelium, interstitial fibrosis, tubular dilation, interstitial infiltration with lymphocytes were observed in two males and in females administered 3000 ppm cryolite. Dilation of Bowman¿s space was reported in one male and one female receiving 10000 ppm cryolite. In addition, haematopoiesis in the liver and spleen, megakaryocytosis in the spleen, and myelofibrosis in the bone marrow were observed in males and females administered 10000 ppm cryolite.
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 95 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: Increases in emesis, nucleated cells, and renal lesions
- Dose descriptor:
- LOAEL
- Effect level:
- 105 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: Increases in emesis, renal lesions, and a decrease in urine specific gravity
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.