NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1303-96-4
Chemical Name	Sodium tetraborate decahydrate [Borax]
Substance ID	m-nite-1303-96-4_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 (ICSC (J) (2014)).	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 (ICSC (J) (2014)).	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 (ICSC (J) (2014)).	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 contains metalloids (B), but it is estimated that it does not react vigorously with water from the measurement data of water solubility of 5.1 g/100 mL water (ICSC (J) (2014)).	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 containing oxygen, but 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)	Not classified	- -	-	-	There were reports of LD50 values for rats of 3,493 mg/kg, 4,500 mg/kg, 4,980 mg/kg, 5,660 mg/kg, 6,080 mg/kg (EHC 204 (1998)), and 4,500-6,000 mg/kg (ECETOC TR63 (1995), PATTY (6th, 2012)). Three cases correspond to "Not classified" (Category 5 in UN GHS classification), and 3 cases correspond to "Not classified." This substance was classified as "Not classified" (Category 5 in UN GHS classification) by adopting a category with higher hazard.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the report of the LD50 value of > 10,000 mg/kg for rabbits (HSDB (Access on August 2017)), the substance was classified as "Not Classified."	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	- -	-	-	There was a report of an LC50 value of > 2 mg/L in a 4-hour inhalation exposure test with rats (PATTY (6th, 2012)), and this value corresponds to Category 4 or "Not classified." However, it was classified as "Classification not possible" since it is not possible to specify the category only from this data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Based on the description that dermatitis was observed in workers exposed to this substance (borax dust) in the mine production section and crushing equipment (ACGIH (7th, 2001)) and the results that skin irritation was observed in skin irritation tests with rabbits and guinea pigs (ECETOC TR63 (1995), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), this substance was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There are descriptions that eye irritation was observed after exposures to 0.44–3.1 mg boron/m3 (5.7–14.6 mg particulates/m3, weighted mean in 6 hours) among borax processing facility workers (ATSDR (2010)) and that a significant difference was observed in the frequency of eye irritation, which was observed in 12.4% of workers in a borax crushing and refining plant but in 2.8% of workers in a low-exposure area (EHC 204 (1998)). In addition, there are descriptions that severe irritation was observed in an eye irritation test with rabbits (PATTY (6th, 2012)), and that in another test with rabbits, conjunctiva discoloration, blistering, and thickening developed and corneal irritation resolved after 8-21 days (ECETOC TR63 (1995)). Therefore, this substance was classified in Category 2.	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. No data were available for in vivo. As for in vitro, bacterial reverse mutation tests and mammalian cell gene mutation tests were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), EHC 204 (1998)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Borates including this substance are classified in A4 by ACGIH (ACGIH (7th, 2005)). 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	In a test in which male rats were dosed with this substance by feeding at 1000 or 2000 ppm for up to 60 days before mating with untreated females, and male fertility was investigated, a reversible decrease of fertility was observed at 1,000 ppm (50 mg Boron/kg/day), and male fertility disappeared completely at 2,000 ppm (100 mg Boron/kg/day) during the 12-week observation period (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2010)). In addition, in a reproductive toxicity study in which this substance was administered to female and male rats by feeding at up to 1,170 ppm (58.5 mg Boron/kg/day), testis atrophy, a decrease of ovulation count, and complete infertility were observed in the dosed groups at 1,170 ppm. Moreover, infertility was also observed when females in the administration group at 1,170 ppm were mated with males in the control group (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2010)). From the above, as for experimental animals, this substance decrease the fertility both of males and females at doses where general toxicity was not observed clearly. Therefore, this substance was classified in Category 1B. Besides, the EU also classified this substance as Repr. 1B (ECHA CL Inventory (Access on August 2017)). The category was changed from the previous classification based on new information sources.	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	Sodium borates including this substance dissolve in water to form boric acid at biological pH (CAS RN 10043-35-3) (PATTY (6th, 2012)). The main hazard information on boric acid and borax are 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 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, 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 tetraborate disodium heptaoxide pentahydrate (Na2B4O7.5H2O, CAS RN 12179-04-3), 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 the acute oral effects on experimental animals of boric acid or this substance were central nervous system depression, convulsions and death with death, and the doses were above the guidance value range of Category 2 (rat, mouse: 2,403-6,080 mg/kg) (ACGIH (7th, 2005), ECETOC TR63 (1995)). Putting together the above mentioned information on this substance and tetraboron disodium heptaoxide pentahydrate, this substance was classified in Category 1 (central nervous system, gastrointestinal tract), Category 3 (respiratory tract irritation). Besides, although it was not adopted as evidence of the classification due to unknown details, as for humans, there is a description that serious gastrointestinal irritation, kidney problems, central nervous system depression or vascular prostration may occur and may lead to death if this substance not less than 1g is absorbed from the gastrointestinal tract or skin rapidly (ACGIH (7th, 2001)). The kidney was adopted as the target organ in the previous classification based on the above information. However, there were no details. Also, there was no information on acute or chronic effects on the kidney also in experimental animals. Thus, it was not adopted. Moreover, with regard to Category 1 (respiratory organs) in the previous classification, there was no information on the original source in ACGIH (7th, 2001) in the description, "respiratory organs disease, lung disease, abnormal radiograph of chest X-ray and respiratory tract irritation," which was adopted as the evidence, and the details could not be confirmed. In the other evaluation reports, there is only the information that an increase in nasal secretion was observed in an inhalation exposure study of boric acid or tetraboron disodium heptaoxide pentahydrate. Therefore, it was judged that classification in Category 3 (respiratory tract irritation) was appropriate. From the above, the classification was changed from the previous one.	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, nervous system)	Danger	H372	P260 P264 P270 P314 P501	As for humans, in a cross-sectional study of 629 workers (including 26 women) working in a large scale borax mining and refining plant in the US for more than five years, there was a significantly increased trend of cough, mucus hypersecretion, chronic bronchitis in nonsmoking workers, and shortness of breath in workers with a smoking history. There is a report that no association with the results of pulmonary function examinations or chest X-rays and the exposure concentration (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016), EHC 204 (1998)). Additionally, there is a report that seven cases of newborn infants (aged 6 to 16 weeks) who used a pacifier to which borax and honey mixture was applied for 4 to 10 weeks showed convulsions, irritability, gastrointestinal disorders (diarrhea, vomiting), and the symptoms disappeared with discontinuation of the use (EHC 204 (1998), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2010)). As for experimental animals, atrophy of the testes was observed in multiple studies with rats given in the diet (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2010)). However, all were outside the guidance value range of Category 2. From the above, as the effects on the respiratory organs and nervous system were observed in humans, this substance was classified in Category 1 (respiratory organs, nervous system). Besides, among the human findings, "generalized or alternating focal motor seizure, irritability, cloudy swelling and granular degeneration of the renal tubules" (EHC 204 (1998)), in the previous classification, the effect on the nervous system was in the infants' report described above, however, the finding of the kidney was not adopted due to no details. Additionally, the finding in the testes of experimental animals was based on the exposure level as Boron, and the dose exceeded the guidance value range for Category 2 when converted to this substance. Thus, the classification was changed from the previous one.	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)	Not classified	- -	-	-	From 96-hour LC50 = 125 mg/L [converted value 14.2 mgB/L] for fish (Brachydanio rerio), and 24-hour LC50 = 644 mg/L [converted value 73 mgB/L] for crustacea (Daphnia magna) (WHO EHC: 1998), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 4	- -	H413	P273 P501	Chronic toxicity data were not obtained. Metals are regarded to be non-biodegradable due to an element, and bioaccumulation cannot be estimated form LogKow. In addition, because the possibility of high bioaccumulation cannot be denied, there is a possibility of having chronic toxicity in spite of high water solubility (59,300 mg/L), it was classified in Category 4.	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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