NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	1330-43-4
Chemical Name	Sodium tetraborate
Substance ID	H29-B-002
Classification year (FY)	FY2017
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	FY2006
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

PHYSICAL HAZARDS

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 associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition).
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition).
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition).
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition).
7	Flammable solids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2014)).
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	- -	-	-	Solid (GHS definition).
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ICSC (J) (2014)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (J) (2014)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains metals (Na) and metalloids (B), but it is estimated that it does not react vigorously with water from the observation result of water solubility of 2.56 g/100 mL (ICSC (J) (2014)).
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition).
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound containing oxygen, 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	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	Based on the LD50 value of 2,660 mg/kg for rats (HSDB (Access on May 2017)), this substance was classified as "Not Classified" (Category 5 in UN GHS classification). As for the RTECS data, which was used in the previous classification, the original source was not available, and no details could be confirmed, so it was not adopted. Therefore, the category was changed from the previous classification.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Sodium tetraborate includes the anhydrate (CAS RN 1303-43-4), the pentahydrate (CAS RN 12179-04-3), and decahydrate (CAS RN 1330-96-4), and as for this substance which is the anhydrate, classification was not possible due to lack of data. Besides, there is a report that pentahydrate and decahydrate were not irritating in skin irritation tests with rabbits (DFGOT (2013) (Access on May 2017)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It is reported that eye irritation was observed in workers exposed to sodium tetraborate dust (ECETOC TR63 (1995)). Although it could not be determined whether this was due to this substance or its hydrate and also the seriousness was unknown, this substance was considered to be an eye irritant. Thus, this substance was classified in Category 2B.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. No data is available for in vivo. As for in vitro, bacterial reverse mutation tests, mammalian cell gene mutation tests, mouse lymphoma tests, chromosomal aberration tests, sister chromatid exchange studies were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), ECETOC TR63 (1995), EHC 204 (1998)).
6	Carcinogenicity	Classification not possible	- -	-	-	Borate compounds including this substance are classified in A4 by ACGIH (ACGIH (7th, 2005)). From the above, this substance was classified as "Classification not possible."
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	There is no information on the reproductive toxicity of this substance itself, but information on boric acid is considered to be available as borate salts. In a reproductive toxicity study in which mice and rats were given boric acid by feeding, the infertility due to reduced fertility was observed at doses at which no general toxicity was observed in parental animals. Based on the result of cross-over mating tests, in mice, the cause of infertility was a decreased fertility in males, but in rats, complete infertility was also observed when females in the administration group were mated with males in the control group (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2010)). On the other hand, in the multiple developmental toxicity studies in which pregnant rats and pregnant mice were given boric acid in the diet during the organogenesis period, an increased incidence of malformations (defects and shortening of the 13th rib, dilatation of the lateral ventricle), fetal mortality and neonatal mortality were observed at the level where maternal toxicity occurred (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2010)). Also in a developmental toxicity study with pregnant rabbits given boric acid by gavage during the organogenesis period, increased malformations in the cardiovascular system and fetal mortality were reported at the dose where decreased body weight was observed in the maternal animals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, it is considered that this substance is likely to show the reproduction/developmental toxicity similar to boric acid, as a borate, and this substance was classified in Category 1B. Besides, the EU classified this substance as Repr. 1B (ECHA CL Inventory (Access on May 2017)).
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	No data is available on single exposure of this substance itself in humans and laboratory animals. This substance, its pentahydrate Na2B4O7.5H2O (CAS RN 12179-04-3) and decahydrate Na2B4O7.10H2O (synonym Borax, CAS RN 1303-96-4) dissolve in water to produce boric acid (CAS RN 10043-35-3) (PATTY (6th, 2012)). The main hazard information on boric acid and borax is reported as below. As for humans, it is reported that a 77-year-old man who ingested 30 g of boric acid once with water 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 was reported that eleven newborns who ingested milk containing 4.5-14 g of boric acid showed symptoms of the central nervous system including headache, tremors, 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 boric acid or borax dust, 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 and borax were central nervous system depression, convulsions 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, boric acid and Na2B4O7.5H2O were classified in Category 1 (central nervous system, gastrointestinal tract), Category 3 (respiratory tract irritation) in 2013 and in 2015 respectively in GHS Classification. 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, this substance was classified in Category 1 (central nervous system, gastrointestinal tract), Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs), Category 2 (genetic organs (men))	Danger Warning	H372 H373	P260 P264 P270 P314 P501	As for humans, in a cross-sectional study on 629 workers (including 26 women) working in the 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 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 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, there were no data on this substance (anhydrate) itself, but in a 60-day repeated oral administration toxicity test with rats, atrophy of the seminiferous tubules was reported in the dosed groups 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 (Borax (anhydrous), B4Na2O7, molecular weight: 201.22), 25 mg/kg/day of boron is equivalent to 116.4 mg/kg/day (converted guidance value: 77.6 mg/kg/day) of this substance, which is within the guidance value range for Category 2. As described above, effects on the respiratory organs were observed in humans, and an effect on the testes was 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)). The classification was changed as a result of obtaining new information sources.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Category 3	- -	H402	P273 P501	From 96-hour LC50 = 66 mg/L [converted value 14.2 mgB/L] for fish (Brachydanio rerio) (WHO EHC: 1998), it was classified in Category 3. Besides, the data of hydrate was used for the classification.
11	Hazardous to the aquatic environment (Long-term)	Category 3	- -	H412	P273 P501	Chronic toxicity data were not obtained. Although the behavior in water is unknown, from acute toxicity Category 3, it was classified in Category 3. Besides, the data of hydrate was used for the classification.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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.

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