NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	12179-04-3
Chemical Name	Disodium tetraborate heptaoxide pentahydrate
Substance ID	m-nite-12179-04-3_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	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	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	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	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: 3.2% (20 degrees C) (PATTY (6th, 2012))).	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 which does not contain halogen but contains oxygen. 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	- -	-	-	"This substance is Na2B4O7.5H2O, and borax is Na2B4O7.10H2O, both of which dissolve in water to form boric acid. Therefore, the information of borax and boric acid was quoted for health hazards of this substance." 　From an LD50 value of 2,403 to 4,207 mg/kg in rats for this substance (ACGIH (7th, 2005)), it was classified as "Not classified" (Category 5 in UN GHS classification).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	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))
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)	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))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	The classification is not possible due to lack of data. 　Besides, there is the information that this substance was not irritating in a skin irritation test using rabbits (ACGIH (7th, 2005)), but the details are unknown without further description.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	The classification is not possible due to lack of data. 　Besides, it is reported that eye irritation was observed in workers exposed to boric acid and borax dusts, not this substance (ACGIH (7th, 2005)).	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	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	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))
6	Carcinogenicity	Classification not possible	- -	-	-	There is no carcinogenicity information on this substance itself. However, in a carcinogenicity study in which boric acid was administered to rats or mice for 2 years, it is concluded that there is no evidence of carcinogenicity (ACGIH (7th, 2005), EHC 204 (1998), ATSDR (2010)) and ACGIH classified boric acid and sodium borate in A4 (ACGIH (7th, 2005)). 　Therefore, this substance was classified as "Classification not possible."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	There is no report on the reproductive effects of this substance itself in either humans or experimental animals. As the information of a substance related to this substance, in humans, a study compared the number of live births from the married male workers occupationally exposed to sodium borate with the number of them from the US general marrieds by the Standardized Birth Ratio (SBR). In this study, it is reported exposure levels were categorized into five levels, the relation between them and SBR was investigated, however, no relation was observed. It is reported that reproductive toxicities by high-level exposure to boric acid dust were not observed under the conditions but the sex ratio of live births was different from general (females increased: it is described that the significance of the finding is unclear) (ACGIH (7th, 2005), EHC 204 (1998), ATSDR (2010)). 　There is no report on the reproductive toxicity effects of this substance itself also in experimental animals. However, there are many test results of boric acid by an oral route (feeding) which are considered to be available for the classification of this substance in reproductive toxicity. It is reported that in a three-generation test for rats, sterility of all pairs, testicular atrophy, and azoospermia in males, and ovulation inhibition in females were observed in a group of 58.5 mg boron/kg/day. It is reported that in a two-generation test for mice, a reduced litter size and lower body weight in the offspring were found in a 111 mg boron/kg/day dose group and sterility was found in all of the rats in a 222 mg boron/kg/day dose group. (ACGIH (7th, 2005), ATSDR (2010), EHC 204 (1998)) 　Besides, the following was reported in a teratogenicity test using pregnant female animals by an oral route (feeding) (ACGIH (7th, 2005), ATSDR (2010), EHC 204 (1998)): 　In mice, increased resorptions, decreased fetal body weight and an increased incidence of fetuses with skeletal malformations were found at the doses where toxicity (mild renal lesions) was observed in maternal animals. In rats, lower fetal body weight and an increased incidence of fetuses with skeletal malformations were found from the dose where toxicity effects were not observed in maternal animals. Also in rabbits, increases in prenatal mortality and malformed fetuses were observed at the dose where decreased food intake and vaginal bleeding were observed in maternal animals. 　As above, there is no report on the reproductive toxicity of this substance itself, however, as for boric acid, increases in sterile animals were found in higher dose groups in a reproductive toxicity test using experimental animals and the association with testicular toxicity and ovarian function is suspected. Besides, in developmental toxicity tests in which boric acid were administered through a gestation period or during an organogenetic period, fetal toxicity and increased incidences of malformations (mainly skeletal) occurred in fetuses. In rats, the induction of malformations was shown from the dose where there was no general maternal toxicity. However, there is little information about the reproductive toxicity of boron compounds in humans and it is unclear if reproductive/developmental toxicity effects in experimental animals are applicable to humans. Therefore, taking the effects of oral exposure to boric acid in experimental animals into account, the substance was classified in Category 1B in this hazard class. Besides, this substance is also classified in Repr.1B in CLP classification by EU (ECHA, CL Inventory (Access on June 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, gastrointestinal tract), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	This substance is irritating to the respiratory tract (ACGIH (7th, 2005), HSDB (Access on June 2015)). 　As for humans, in an accident where a 77-year-old took 30 g boric acid (85 mg boron/kg) once to stop hiccup, nausea, vomiting, abdominal pain, diarrhea, erythema, cyanosis in extremities, acute renal failure, and cardiopulmonary hypotension followed by death from heart failure were reported. In an incident where a newborn accidentally ate 4.5 to 14 g boric acid central nervous system effects such as a headache, tremor, restlessness, convulsions, weakness, and coma were reported (ACGIH (7th, 2005), ATSDR (2010), DFGOTvol.5 (1993), HSDB (Access on June 2015)). 　As for experimental animals, acute oral effects of borax and boric acid in the experimental animals were central nervous system effects but the doses were above the guidance value range of Category 2 (rats, mice: 2,403 to 6,080 mg/kg) (ACGIH (7th, 2005)). 　From the above, the doses at which central nervous system effects were observed in experimental animals were above the guidance value range of Category 2. However, the substance was classified in Category 1 (central nervous system) because central nervous system effects such as tremor, restlessness, convulsions, weakness, and coma were found in a human case. Because effects on the digestive tract such as nausea, vomiting, abdominal pain, and diarrhea were observed in humans, the substance was classified in Category 1 (digestive tract). Besides, there were cyanosis, acute renal failure and cardiopulmonary findings in humans. However, there were no acute signs suggesting these in experimental animals and no human case with the similar acute effects. On top of that, the findings were from an aged person. Taking account comprehensively these points, the findings were not targeted for the classification. 　Therefore, the substance was classified in Category 1 (central nervous system, digestive tract), Category 3 (respiratory tract irritation).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is no information on this substance. 　Toxicity information on boric acid in an oral route was obtained in experimental animals. 　In a 9-week repeated dose toxicity test, a 13-week repeated dose toxicity test and a 2-year repeated dose toxicity test in which boric acid were applied to rats or mice by feeding, aspermatogenesis, testicular atrophy, and seminiferous tubule atrophy were found at the doses (not less than 150 mg/kg/day, not less than 26.3 mg boron/kg/day) which is above the range of Category 2. 　Furthermore, in a 2-year repeated diet administration toxicity test using rats, swelling and epidermolysis in extremities, and inflamed eyelids in males and females and decreases in hematocrit and hemoglobin levels in females were observed (ACGIH (7th, 2005), EHC 204 (1998), ATSDR (2010)). Although it is classified as "Not classified" in an oral route, there is no toxicity information for other routes. 　Therefore, the substance was classified as "Classification not possible" due to lack of data.	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)	Classification not possible	- -	-	-	The classification is not possible because appropriate data are not obtained.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	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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