NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	12280-03-4
Chemical Name	Disodium octaborate tetrahydrate
Substance ID	m-nite-12280-03-4_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 associated with explosive properties present in the molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is not combustible (GESTIS (Access on September 2017)).	FY2017	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (GESTIS (Access on September 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (GESTIS (Access on September 2017)).	FY2017	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 the measurement result of water solubility of 95 g/L (20 deg C) (GESTIS (Access on September 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	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. However, the classification is not possible due to no data.	FY2017	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2017	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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, boric acid (CAS RN 10043-35-3) was classified as "Classification not possible" (FY2013 GHS Classification).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	There is no data of this substance itself. However, since it is described that this substance exists as boric acid in a solution at physiological pH (PATTY (6th, 2012)), it is considered that the toxic effects of this substance are similar to those of boric acid (CAS RN 10043-35-3), and that the classification result of boric acid (FY2013 GHS Classification: "Classification not possible") is applicable. Therefore, it was classified as "Classification not possible."	FY2017	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 data on this substance itself. However, since it is described that this substance exists as boric acid in a solution at physiological pH (PATTY (6th, 2012)), it is considered that the toxic effects of this substance are similar to those of boric acid (CAS RN 10043-35-3), and that the classification result of boric acid (FY2013 GHS Classification: Category 1B) is applicable. Therefore, it was classified in Category 1B for this hazard class. Besides, EU also classified this substance as "Repr. 1B" (ECHA CL Inventory (Access on August 2017)).	FY2017	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	There is no information on single exposure to this substance in humans and experimental animals. Based on the description that this substance exists as boric acid (CAS RN 10043-35-3) in a solution at physiological pH as with other sodium borates (PATTY (6th, 2012)), it is considered that the information on the toxic effects of boric acid and other sodium borates is useful. The followings are reported as the main hazard information of boric acid, tetraboron disodium heptaoxide pentahydrate (Na2B4O7.5H2O, CAS RN 12179-04-3) which is disodium tetraborate pentahydrate, and borax (Na2B4O7.10H2O, CAS RN 1303-96-4) which is disodium tetraborate decahydrate. As for humans, it is reported that a 77-year-old man who ingested 30 g of boric acid with water at one time developed nausea, vomiting, abdominal pain, diarrhea, erythema, cyanotic extremities, acute renal failure and cardiopulmonary hypotension, and died from cardiac insufficiency (ATSDR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, it is reported that eleven newborns who ingested milk containing 4.5-14 g of boric acid showed symptoms of the central nervous system including headache, tremor, restlessness, convulsions, weakness, and coma in addition to vomiting and diarrhea, and five of them died within three days (ATSDR (2010), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Moreover, it was reported that in a single inhalation exposure study with volunteers given the dust of boric acid or tetraborate disodium heptaoxide pentahydrate, an increase in nasal secretion was observed (ACGIH (7th, 2005), ATSDR (2010), DFGOT (2013) (Access on May 2017)). As for experimental animals, it was reported that acute oral effects on experimental animals of boric acid or borax were central nervous system depression, convulsion and death, and the doses were above the guidance value range of Category 2 (rat, mouse: 2,403-6,080 mg/kg) (ACGIH (7th, 2005)). Based on the above information, both boric acid and tetraboron disodium heptaoxide pentahydrate were classified in Category 1 (central nervous system, gastrointestinal tract), Category 3 (respiratory tract irritation) in the GHS Classification of 2013 and 2015, respectively. Since this substance also dissolves in water to form boric acid, it is considered that it is likely to show effects similar to these substances. Therefore, it was classified in Category 1 (central nervous system, gastrointestinal tract), Category 3 (respiratory tract irritation).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs), Category 2 (reproductive organs (male))	Danger Warning	H372 H373	P260 P264 P270 P314 P501	There is no information on this substance itself. There is a description that since all sodium borates exist as boric acid (B(OH)3) in a solution at physiological pH, toxic effects are common to all sodium borates (PATTY (6th, 2012)). Therefore, the information of other sodium borates and boric acid is useful. As for humans, in a cross-sectional study of 629 workers (including 26 women) working in a US large scale borax mining and refining plant for five years or more, total dust concentrations (weighted mean) in the workplace were 14.6 mg/m3 in the anhydrous borax production section, 8.4 mg/m3 in the shipment section, 4.0 mg/m3 in the mine and the maintenance section, 1.1 mg/m3 in the non-production section. With regard to persistent symptoms, the workers were divided into two groups based on the presence or absence of smoking history and then divided into three exposure concentration groups of low (0.9 mg/m3), medium (4.5 mg/m3), and high (14.6 mg/m3). As a result of examination, there was a significantly increased trend of cough, mucus hypersecretion, chronic bronchitis in the nonsmoking workers, and shortness of breath in the workers with a smoking history. Besides, there are reports that the results of pulmonary function examination or chest X-ray examination were not related to the exposure concentration (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), EHC 204 (1998)). As for experimental animals, toxicity information on the oral route of disodium tetraborate decahydrate (CAS RN 1303-96-4) and boric acid (CAS RN 10043-35-3) was obtained. In a 60-day repeated oral administration toxicity test with rats given disodium tetraborate decahydrate by feeding, atrophy of the seminiferous tubules was reported in the group dosed at 500 ppm (25 mg/kg/day as boron) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). When this dosage is converted based on boron (B, molecular weight: 10.81) and this substance (Na2B8O13.4H2O, molecular weight: 412.52), it is equivalent to 119.3 mg/kg/day (converted guidance value: 79.5 mg/kg/day) of this substance, which is within the guidance value range for Category 2. In addition, in a 9-week, 13-week or 2-year repeated dose toxicity test with rats or mice given boric acid by feeding, spermatogenesis inhibition, atrophy of the testis and atrophy of the seminiferous tubules were reported in the group dosed at or above 150 mg/kg/day (26.3 mg/kg/day as boron). When this dosage is converted based on boron (B, molecular weight: 10.81) and this substance (Na2B8O13.4H2O, molecular weight: 412.52), it is equivalent to 125.5 mg/kg/day of this substance, which corresponds to "Not classified." Moreover, in a 2-year repeated dose toxicity test with rats dosed by feeding, swelling of the limbs, desquamation, and eyelid inflammation were observed in males and females, and decreases in hematocrit value and hemoglobin content were observed in females (ACGIH (7th, 2005), EHC 204 (1998), ATSDR (2010)). As described above, effects on the respiratory organs were observed in humans, and it was considered that effects on the testes were observed within the guidance value range for Category 2 in experimental animals. Therefore, this substance was classified in Category 1 (respiratory organs), Category 2 (genetic organs (men)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	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	- -	-	-	No data available.	FY2017	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 available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	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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