GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 13775-53-6 |
| Chemical Name | Trisodium hexafluoroaluminate |
| Substance ID | H27-B-016/C-037B_P |
| Classification year (FY) | FY2015 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2008 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
| Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive properties. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Not classified |
- |
- | - | It is non-flammable (GESTIS (Access on June 2015)). |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is non-flammable (GESTIS (Access on June 2015)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is non-flammable (GESTIS (Access on June 2015)). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | It is estimated that it does not react vigorously with water from water solubility data measured. Water solubility: 410 mg/L (GESTIS (Access on June 2015)). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an inorganic compound that does not contain oxygen but contains halogen (F), but the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an inorganic compound. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No established test method suitable for solid substances. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | From a reported LD50 value (OECD TG 401) of > 5,000 mg/kg for rats (ECHA RAC (2010)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, an LD50 value of > 5,000 mg/kg in rats was reported for the natural mineral of this substance (CAS 15096-52-3) (EPA Pesticide (1996)). Because IUCLID (2000) data, the rationale for the previous classification could not be confirmed due to the closure of the search site, the Category was revised. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Category 4 |
 Warning |
H332 | P304+P340 P261 P271 P312 |
From a reported LC50 value (4 hours) (OECD TG 403) of 4,470 micro g/L (4.47 mg/L) for rats (ECHA RAC (2010)), it was classified in Category 4. Based on the ECHA RAC (2010) data newly obtained in this investigation, the Category was revised. Besides, from the information that test was conducted on aerosol containing particles of this substance, a reference value of mists and dust was applied. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | For the natural mineral of this substance (CAS 15096-52-3), it is reported that no irritation was observed in a skin irritation test using rabbits (EPA Pesticide (1996)). Moreover, it is reported in EU-RAR (2008) that no irritation was found after application of a 50% solution of this substance for 24 hours in a maximization test using guinea pigs, and that no irritation was observed after 8-hour or 24-hour application of this substance in rabbits (EU-RAR (2008)). From the above results, it was classified as "Not classified." |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
For application of this substance (synthetic cryolite) into rabbit eyes, it is reported that no irritation reaction was observed in conjunctiva, sclera, and cornea (ECHA RAC (2010)), and it is written that moderate conjunctivitis was observed but resolved within seven days (ECHA RAC (2010)). Furthermore, for the natural mineral of this substance (CAS 15096-52-3), it is reported that moderate irritation was found in an eye irritation test using rabbits (EPA Pesticide (1996)). As above, based on the information of reversibility, the substance was classified in Category 2B. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is reported in EU RAR (2008) that in a maximization test using guinea pigs, effects were not observed, but it was judged as insufficient data to be used for the classification due to unknown details. Moreover, it is reported that the natural mineral of this substance (CAS 15096-52-3) caused rash and atopic dermatitis in workers (PATTY (6th, 2012)). |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo data, a chromosomal aberration test in rat bone marrow cells was negative (EU-RAR (2008)). As for in vitro, for this substance (synthetic cryolite) and the natural mineral (CAS 15096-52-3), a bacterial reverse mutation test, a chromosomal aberration test in human lymphocytes, and an unscheduled DNA synthesis test in primary rat hepatocytes were all negative. (EPA Pesticide (1996), EU-RAR (2008)) |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | There is no data on this substance (synthetic cryolite), but for the natural mineral of this substance (CAS 15096-52-3) that had been registered and used as a pesticide in 1957 or later, US EPA classified in Group D (not classifiable as to human carcinogenicity) in 1988 (EPA Pesticide (1996)). On the other hand, ACGIH classified fluorides in A4 as fluorine (ACGIH (7th, 2001)). As above, because no information of the natural mineral or fluorides suggests carcinogenicity related to this substance, it was classified as "Classification not possible." |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | There is no test data using this substance (synthetic cryolite). As test data using the natural mineral of this substance (CAS 15096-52-3), there is a report from a two-generation diet administration test in rats, in which even after administration at up to the highest dose of 1,800 ppm (a dose corresponding to 128-149 mg/kg/day), parent animals showed no effects on fertility, but weight gain reduction was observed in offspring by weaning (EU-RAR (2008)). Moreover, as developmental toxicity effects, it is reported that in a test in pregnant rats or rabbits in gavage administration of natural cryolite, an increased incidence of skeletal variations (bent ribs or limb bones) or malformations (cleft palate) was found at the doses (100-300 mg/kg/day or higher) where maternal animals showed marked toxicity effects (weight gain reduction, dark red mucosa/contents of the stomach, death cases) (EU-RAR (2008)). However, on the other hand, it is reported that in a test in pregnant rats in gavage administration of the maximum dose: 3,000 mg/kg/day on day 6-15 of gestation, only whitening of teeth was observed in maternal animals but no effects were found in fetuses (EU-RAR (2008)). The ECHA Committee for Risk Assessment (RAC) considered Category 2 classification in CLP criteria from the above mentioned reproductive toxicity test result in the process of assessing risk/hazard of both this substance and the natural one. However, because the reliability of the developmental toxicity data is doubted due to a big difference in results from the multiple tests, it is concluded that classification is not given on reproductive toxicity (ECHA RAC (2010)). As above, because the developmental toxicity test results on natural cryolite are inconsistent as EU pointed out, the substance was classified as "Classification not possible" in this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (respiratory organs, liver) |
 Warning |
H371 | P308+P311 P260 P264 P270 P405 P501 |
This substance (synthetic cryolite) is irritating to the respiratory tract (EPA Pesticide Fact Sheet (1996), EU-RAR (2008)). As for experimental animals, it is reported that rats showed weakness and labored breathing at 250 mg/kg or higher (corresponding to Category 1), piloerection and salivation at > 5,000 mg/kg (LD50) in oral administration of this substance (synthetic cryolite), alveolar septum fibrosis and so on in the lung, and centrilobular degeneration/necrosis of hepatocytes in the liver in inhalation exposure at 1.33-4.34 mg/L (corresponding to Category 2) (EU-RAR (2008)). Labored breathing in oral administration (corresponding to Category 1) was not judged as effects on the respiratory system, and it was classified in Category 2 (respiratory system, liver) from the information of effects on the lung and liver in the inhalation test (corresponding to Category 2). By adding new information, the Category of the previous classification was revised. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (nervous system, bone, teeth, lung, liver, kidney, stomach) |
Danger |
H372 | P260 P264 P270 P314 P501 |
As the information on this substance (synthetic cryolite), in a 5-month repeated inhalation toxicity test using rats, the following was observed at 0.001 mg/L (ECHA RAC (2010)): permanent stiffness, decreased spontaneous motility, decreased plasma cholinesterase activity, increased fluorides in urine/bones/teeth, periosteal/osteal dystrophic/osteolytic lesions of bones, enamel defects of teeth, alveolitis, hyperplasia of tracheal/bronchial lymph nodes, fatty degeneration and single cell necrosis of hepatocytes, necrosis of proximal tubules, focal submucosal inflammation of the glandular stomach, and perivascular inflammation and proliferation of neuroglia cells of the brain. These were seen at the dose within a range of Category 1. Moreover, changes in color and physical property of teeth were found in a 28-day repeated oral administration toxicity test using rats at 25 mg/kg/day (converted to a 90-day equivalent: 7.78 mg/kg/day) (ECHA RAC (2010)). These were within a range of Category 1. On the other hand, as the information on the natural mineral of this substance (CAS 15096-52-3), as for humans, skeletal fluorosis with joint pain and limited movement of joints was reported in long-term occupational exposure to dust of natural cryolite (EU-RAR (2008), ECHA RAC (2010)). Moreover, dental fluorosis was reported due to indirect exposure to fluorides in children of Danish workers related to natural cryolite (ECHA RAC (2010)). Besides, as for experimental animals, the following was observed in a 90-day repeated inhalation toxicity test using rats (ECHA RAC (2010)): alveolitis with trace thickening of alveolar duct wall in the lung at 0.00104 mg/L; and increased concentrations of inorganic fluorides in bones and teeth, increased absolute lung weight, accumulation of phagocytic macrophages in tracheal/bronchial lymph nodes at 0.0046 mg/L. These were seen at the dosed within a range of Category 1. Therefore, the substance was classified in Category 1 (nervous system, bone, tooth, lung, liver, kidney, stomach). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 2 |
- |
H401 | P273 P501 |
From EC50 = 10.0 ppm for crustacea (Daphnia pulex) (U.S. EPA: RED, 1996), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 2 |
 - |
H411 | P273 P391 P501 |
Reliable chronic toxicity data were not obtained. Due to an inorganic compound, no data got on rapid degradability, and acute toxicity Category 2, it was classified in Category 2. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
NOTE:
| * A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |