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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
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:
- key study
- Study period:
- 1991
- 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:
- 1 991
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Use of guideline not reported
- Deviations:
- not specified
- 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
- Analytical purity: 97.3%
- Purity test date: Not reported
- 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:
- mouse
- Strain:
- CD-1
- 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): Not reported
- 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: From: Not reported To: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methylcellulose suspension
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
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
- Details on mating procedure:
- - Impregnation procedure: Not reported
- If cohoused: Not reported
- M/F ratio per cage: Not reported
- Length of cohabitation: Not reported
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility: Not reported
- Further matings after two unsuccessful attempts: Not reported
- Verification of same strain and source of both sexes: Not reported
- Proof of pregnancy: Not reported
- Any other deviations from standard protocol: Not reported - Duration of treatment / exposure:
- day 6 to day 15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- Not reported
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 100, or 300 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 25
- Control animals:
- other: Yes, control, however, details as to whether it was sham-exposed, concurrent no treatment or concurrent vehicle only was not reported
- Details on study design:
- - Dose selection rationale: Not reported
- Rationale for animal assignment (if not random): Not reported
- Other: Not reported
Examinations
- Maternal 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: Not reported
- Time schedule for examinations: Not reported
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # Not reported
- Organs examined: Not reported
OTHER: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Not reported
Examinations included:
- Gravid uterus weight: Not reported
- Number of corpora lutea: Not reported
- Number of implantations: Not reported
- Number of early resorptions: Not reported
- Number of late resorptions: Not reported
- Other: Not reported - Fetal examinations:
- - External examinations: Not reported
- Soft tissue examinations: Not reported
- Skeletal examinations: Not reported
- Head examinations: Not reported - Statistics:
- Not reported
- Indices:
- Not reported
- Historical control data:
- Not reported
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Increased mortality at 300 mg/kg/day.
Glandular portion of stomach was red beginning at 100 mg/kg/day.
Females in the 300 mg/kg/day group exhibited dark red contents of the stomach.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- LOEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Fetuses at 300 mg/kg/day exhibited bent ribs and bent limb bones
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Not reported
Applicant's summary and conclusion
- Executive summary:
"RAC is of the view that the maternal mortality in the two "positive" mouse studies (this study and an additional study cited by them) is too high to allow any meaningful conclusions on developmental toxicity to be drawn from these studies (CLP Regulation, Annex I §3.7.2.4.4 "Maternal mortality greater than 10 % is considered excessive and the data for that dose level shall not normally be considered for further evaluation."). Overall, there is then no support for classification from the developmental toxicity studies".
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