GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 12179-04-3
Chemical Name Disodium tetraborate heptaoxide pentahydrate
Substance ID H27-A-008, C-008A_P
Classification year (FY) FY2015
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
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 present in the molecule associated with explosive properties.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- -  "Solids" according to GHS definition.
3 Aerosols Not applicable
-
-
- -  Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- -  "Solids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- -  "Solids" according to GHS definition.
6 Flammable liquids Not applicable
-
-
- -  "Solids" according to GHS definition.
7 Flammable solids Classification not possible
-
-
- -  Due to no data, the classification is not possible.
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
-
-
- -  "Solids" according to GHS definition.
10 Pyrophoric solids Classification not possible
-
-
- -  Due to no data, the classification is not possible.
11 Self-heating substances and mixtures Classification not possible
-
-
- -  Due to no data, the classification is not possible.
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))).
13 Oxidizing liquids Not applicable
-
-
- -  "Solids" according to GHS definition.
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.
15 Organic peroxides Not applicable
-
-
- -  It is an inorganic compound.
16 Corrosive to metals Classification not possible
-
-
- -  No established test method suitable for solid substances.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
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).
1 Acute toxicity (Dermal) Classification not possible
-
-
- -  Due to lack of data, the classification is not possible.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- -  Due to lack of data, the classification is not possible.
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.
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)).
4 Respiratory sensitization Classification not possible
-
-
- -  Due to lack of data, the classification is not possible.
4 Skin sensitization Classification not possible
-
-
- -  Due to lack of data, the classification is not possible.
5 Germ cell mutagenicity Classification not possible
-
-
- -  Due to lack of data, the classification is not possible.
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."
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)).
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).
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.
10 Aspiration hazard Classification not possible
-
-
- -  Due to lack of data, the classification is not possible.

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) Classification not possible
-
-
- -  The classification is not possible because appropriate data are not obtained.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- -  No data.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data.


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 iGHSj in United Nations.

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