GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 12280-03-4 |
| Chemical Name | Disodium octaborate tetrahydrate |
| Substance ID | H29-A-006 |
| Classification year (FY) | FY2017 |
| 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) | |
| Model SDS by MHLW (External link) | |
| OECD/eChemPortal (External link) | eChemPortal |
| 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 (GESTIS (Access on September 2017)). |
| 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 (GESTIS (Access on September 2017)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on September 2017)). |
| 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)). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 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. |
| 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. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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 |
- |
- | - | Classification not possible due to lack of data. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. Besides, boric acid (CAS RN 10043-35-3) was classified as "Classification not possible" (FY2013 GHS Classification). |
| 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." |
| 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)). |
| 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). |
| 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 |
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)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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 |
- |
- | - | No data available. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data available. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |