NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	13775-53-6
Chemical Name	Trisodium hexafluoroaluminate
Substance ID	m-nite-13775-53-6_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is non-flammable (GESTIS (Access on June 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is non-flammable (GESTIS (Access on June 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is non-flammable (GESTIS (Access on June 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic compound.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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))	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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