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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1994
- 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:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- no
- 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: 96%
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Storage condition of test material: not reported
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: not reported
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: not reported
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): not reported
- Mixing appropriate amounts with (Type of food): not reported
- Storage temperature of food: not reported
VEHICLE
- Justification for use and choice of vehicle (if other than water): not reported
- Concentration in vehicle: not reported
- Amount of vehicle (if gavage): not reported
- Lot/batch no. (if required): not reported
- Purity: not reported - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not reported
- Duration of treatment / exposure:
- not reported
- Frequency of treatment:
- Daily in diet
- Details on study schedule:
- - F1 parental animals not mated until [...] weeks after selected from the F1 litters: not reported
- Selection of parents from F1 generation when pups were [...] days of age: not reported
- Age at mating of the mated animals in the study: [...] weeks: not reported
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200, 600, or 1800 ppm
Basis:
nominal in diet
representing 14, 42, or 128 mg/kg bw/day for males and 16, 49, or 149 mg/kg bw/day for females, respectively, during premating.
- No. of animals per sex per dose:
- 30 animals per group (#/sex not specified)
- Control animals:
- other: Yes, a dose level of 0 ppm is assumed to be a plain diet
- Details on study design:
- - Dose selection rationale: not reported
- Rationale for animal assignment (if not random): not reported - Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: not reported
- Cage side observations checked in table [No.?] were included: not reported
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: not reported
BODY WEIGHT: No data
- Time schedule for examinations: not reported
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data - Oestrous cyclicity (parental animals):
- not reported
- Sperm parameters (parental animals):
- not reported
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: not reported
- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded: not reported
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring: not reported
[number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, other:]
GROSS EXAMINATION OF DEAD PUPS:
yes (1800 ppm group only), for external and internal abnormalities; possible cause of death was not determined for pups born or found dead. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: not reported
- Maternal animals: not reported
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]: not reported
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively: not reported - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age: not reported
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows: not reported
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]: not reported
HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively: not reported - Statistics:
- not reported
- Reproductive indices:
- not reported
- Offspring viability indices:
- not reported
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Details on results (P0)
Dental fluorosis: whitening of the upper and/or lower incisors was observed in most treated animals of both generations. Bevelled anterior edge of the lower incisor was observed in at least 67% of animals from both generations at 1800 ppm.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
not reported
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
not reported
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
not reported
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
not reported
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
not reported
ORGAN WEIGHTS (PARENTAL ANIMALS)
not reported
GROSS PATHOLOGY (PARENTAL ANIMALS)
not reported
HISTOPATHOLOGY (PARENTAL ANIMALS)
not reported
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- reproductive toxicity
- Effect level:
- 600 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: The NOEL is based on decreased pup body weights
- Remarks on result:
- other: Generation: general (not specified) (migrated information)
- Dose descriptor:
- LOEL
- Effect level:
- 1 800 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: The LOEL is based on decreased pup body weights
- Remarks on result:
- other: Generation: General (not specified) (migrated information)
- Dose descriptor:
- LOEL
- Remarks:
- systemic toxicity
- Effect level:
- 200 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: The LOEL is based on dental fluorosis
- Remarks on result:
- other: Generation: both parental (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings:
- not specified
Details on results (F1)
Not reported
CLINICAL SIGNS (OFFSPRING)
Not reported
BODY WEIGHT (OFFSPRING)
significantly decreased pup body weights during lactation days 7, 14, and 21 (82%-88% of control in F1 offspring) and days 4, 7, 14, and 21 (74%-89%) of control in F2 offspring
SEXUAL MATURATION (OFFSPRING)
not reported
ORGAN WEIGHTS (OFFSPRING)
not reported
GROSS PATHOLOGY (OFFSPRING)
Pale kidneys, pale livers and enlarged hearts (@ 1800 ppm)
HISTOPATHOLOGY (OFFSPRING)
not reported
OTHER FINDINGS (OFFSPRING)
not reported
Overall reproductive toxicity
- Reproductive 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.