GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 7727-43-7 |
| Chemical Name | Barium sulfate |
| Substance ID | H28-A-003, C-006A |
| Classification year (FY) | FY2016 |
| 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 |
| 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 (2005)). |
| 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 (2005)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (ICSC (2005)). |
| 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 due to the observation result of water solubility (2.5 mg/L (20 deg C), GESTIS (Access on May 2016)). |
| 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. |
| 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. Besides, it is described in CICAD 33 (2001) that the physicochemical properties of barium sulfate and the lack of reports on skin irritation in humans despite its widespread use, particularly for X-ray purposes, suggest that barium sulfate is not irritating or corrosive to the skin. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Besides, it is described in a CICAD that the physicochemical properties of barium sulfate and the lack of reports of eye irritation in humans despite its widespread use, particularly for X-ray purposes, suggest that barium sulfate is not irritating or corrosive to eyes (CICAD 33 (2001)). |
| 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. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - |
There is no carcinogenicity information on this substance itself. However, as described in the section on the classification of barium, from the results of experimental animal studies using barium chloride dihydrate, the EPA classified barium and its compounds as Group D or NL (IRIS (1998)), and ACGIH classified barium and its soluble compounds as A4 (ACGIH (7th, 2001)). Therefore, based on these classifications by other organizations, this substance was classified as Classification not possible. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Besides, there is a report that as results of a cohort study representing the incidence of malformations in children born from mothers who received an upper gastrointestinal X-ray examination using this substance as a contrast agent, it was concluded that the occurrence of malformations was at low frequency and not different from the control group, and there was no association between the radiation and the barium sulfate exposure in early pregnancy and the birth (ACGIH (7th, 2014)). |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Besides, in humans, multiple case reports are reported of adverse side effects (including fever, dyspnea, hypoxemia, allergy, mild fibrosis, and death) associated with the aspiration of barium sulfate occurring accidentally during its use as a contrast medium in radiographic studies of the gastrointestinal tract (ACGIH (7th, 2014)). Also as side effects of barium sulfate as a contrast agent, in addition to anaphylactoid symptoms, gastrointestinal symptoms such as difficulty in defecation, constipation, transient diarrhea/abdominal pain, anal pain and bleeding etc., and hypersensitivity such as rash, itching, urticaria, nausea and vomiting may appear (Pharmaceutical Interview Forms (IF) (Phase 1 Re-evaluation Result No.19 (1982), voluntary revision (1995)). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs) |
 Danger |
H372 |
P260
P264 P270 P314 P501 |
The toxicity of a barium compound is dependent on its water solubility; the lack of case reports on systemic toxicity despite routine oral administration for many years of barium sulfate as a radiocontrast medium indicates that this practically insoluble barium compound is not toxic by the oral route (CICAD 33 (2001)). In humans, in the inhalation route, reversible baritosis is reported in workers occupationally exposed to barium sulfate which is an insoluble barium salt or barite ore (CICAD 33 (2001)). From the above, pneumoconiosis due to inhalation exposure to this substance is reported. Therefore, this substance was classified in Category 1 (respiratory organs). |
| 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) | Category 3 |
- |
H402 |
P273
P501 |
From 48-hour EC50 = 32 mg/L for crustacea (Daphnia magna) (CICADs, 2001), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 |
P273
P501 |
Reliable chronic toxicity data were not obtained. Because environmental dynamics of the inorganic compound is unknown, and it is classified in Category 3 for acute toxicity, it was classified in Category 3. |
| 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. |