GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 1303-96-4
Chemical Name Sodium tetraborate decahydrate [Borax]
Substance ID H29-B-092
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)  
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 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)).
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
-
-
- - 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.
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."
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
-
-
- - 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.
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.
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.
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 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)).
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."
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.
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.
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.
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) 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."
11 Hazardous to the aquatic environment (Long-term) 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.
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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