GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 7789-38-0 |
| Chemical Name | Sodium bromate |
| Substance ID | H29-B-062 |
| 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 | FY2008 |
| 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 classified |
- |
- | - | There is a chemical group associated with explosive properties (O-halogen) in the molecule, but because it is classified in Division 5.1, PG II in UNRTDG (UN 1494), it does not correspond to explosives, hazard class with the highest precedence. |
| 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) (2006)). |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There is a chemical group associated with explosive properties (O-halogen) in the molecule, but it is classified in oxidizing solids. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is not combustible (ICSC (J) (2006)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (ICSC (J) (2006)). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Category 2 |
 Danger |
H272 |
P370+P378
P210 P220 P221 P280 P501 |
Because t is classified in Division 5.1, PG II in UNRTDG (UN 1494), it was classified in Category 2. |
| 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 | Category 2 |
 Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
Based on descriptions that this substance is irritating to the skin in humans (HSDB (Access on June 2017)), and that bromide or bromate caused burns on the epidermis of rabbits in prolonged contact, but they resolved in a few days (PATTY (6th, 2012)), it was classified in Category 2. Based on the information obtained in this investigation, the category was revised. |
| 3 | Serious eye damage/eye irritation | Category 2 |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
Based on the descriptions that this substance is irritating to the eyes in humans (HSDB (Access on June 2017)), and that bromide or bromate caused moderate irritation and mild corneal injury to the eyes of rabbits, but they resolved in a few days (PATTY (6th, 2012)), it 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 | Category 2 |
 Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for this substance, there are reports that as for in vivo, it was positive in a micronucleus test with mouse bone marrow cells and peripheral blood (NTP DB (Access on July 2017), NTP GMM 6 (2007), HSDB (Access on June 2017)), and that as for in vitro, it was negative in a bacterial reverse mutation test (HSDB (Access on June 2017)). From the above, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. |
| 6 | Carcinogenicity | Category 2 |
Warning |
H351 |
P308+P313
P201 P202 P280 P405 P501 |
In none of the tests in which this substance was dermally applied to both sexes of transgenic mice (Tg. AC mice) at up to 256 mg/kg/day for up to 39 weeks, and tests in which it was administered by drinking water to both sexes of two strains of transgenic mice (p53 deficient mice or Tg. AC mice) at up to 800 mg/L (equivalent to 65-152 mg/kg/day) for up to 43 weeks, there was no increase in tumor incidence, and no evidence of carcinogenicity was shown (NTP GMM 6 (2007)). On the other hand, there was a report from a carcinogenicity test in which potassium bromate (CAS RN 7758-01-2) was administered to normal test animals, and this was considered to be available as a bromate salt for the classification in this hazard class. In the study in which potassium bromate was administered by drinking water to male rats for 2 years, a significantly increased incidence of renal cell adenoma and carcinoma was observed at the low dose, but a significant increase was not shown at the medium dose or above (IARC 73 (1999)). However, among the two studies in which potassium bromate was dosed in drinking water to male rats for two years, in one study, a significant increase in the incidences of renal tubular adenomas and adenocarcinomas, thyroid follicular tumours, and peritoneal mesothelioma was observed, and in the other study, a significant increase in the incidences of mesothelioma of the testicular tunica vaginalis, renal cell tumours, and thyroid follicular adenomas and carcinomas was observed (IARC 73 (1999)). As for the classification by other organizations, IARC classified potassium bromate in Group 2B (IARC 73 (1999)), EU classified potassium bromate in Carc.1B (ECHA CL Inventory (Access on June 2017)), EPA classified the bromate salt (CAS RN 15541-45-4) as B2 (Probably human carcinogen) (IRIS (2001)). From the above, carcinogenicity was not observed in transgenic mice as data of this substance itself, but as for potassium bromate, carcinogenicity was observed only in male rats. Based on the classification results of potassium bromate or bromate salts by EU and EPA, they correspond to Category 1B, however, by considering that all were negative in the tests with transgenic mice orally and dermally given this substance and the oral dose test with normal mice given potassium bromate, and that IARC classified potassium bromate in Group 2B, classification in Category 2 was judged to be appropriate for this hazard class. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a reproductive and developmental toxicity screening test in which male rats were dosed by drinking water at 25-250 ppm of this substance for 35 days and mated with 2 groups of female rats, and female rats of one group were dosed from mating to early gestation, and the other group was dosed by drinking water from gestational day 6 to delivery at the same concentrations as the males, no effects on female fertility were observed. In the males, the only effect seen in the high dose group (250 ppm) was a decrease in the epididymal sperm count (this alone is not adopted as classification evidence) (IARC 73 (1999), Risk Assessment Report (chemical substances and pollutants) (Food Safety Commission of Japan, 2008)). This test is a screening test, and it was not possible to classify it as "Not classified" by this result alone, and there are no data available for classification other than this one. Therefore, the classification is not possible. Besides, the multi-generation test which was adopted as evidence data for "Not classified" in the previous classification could not be confirmed in NTP DB. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (nervous system, kidney, haemal system), Category 3 (narcotic effects) |
Danger Warning |
H370
H336 |
P308+P311
P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
Four cases of poisoning due to oral ingestion of this substance by accident or suicidal intent are reported in humans (HSDB (Access on June, 2017), PATTY (6th, 2012)). It was reported that severe kidney failure, hearing loss, anemia, and peripheral neuropathy were observed as symptoms (HSDB (Access on June, 2017), PATTY (6th, 2012)). Moreover, there is a description that as for the symptoms of poisoning in humans by oral ingestion of bromate salt (potassium bromate (CAS RN 7758-01-2) or this substance), in addition to the above symptoms, vomiting, abdominal pain, and diarrhea as irritant effects on the stomach and intestines, and lethargy, hypotension, hypotonia, and loss of reflexes as effects on the central nervous system were observed (EHC 216 (2000), IRIS (2001)). From the above, it was classified in Category 1 (nervous system, kidney, haemal system), Category 3 (narcotic effects). In the previous classification, also the gastrointestinal system was included in a target organ, however, this was excluded since it was considered due to irritation from this substance. In addition, it was classified in Category 3 (respiratory tract irritation) in the previous classification based on the description in ICSC (2006), but it was not adopted because ICSC is an information source listed in List 3 in the current GHS classification guidance for the Japanese government. Besides, the following was not adopted as rationale because it was not clearly stated whether it was this substance or potassium bromate: as for experimental animals, there is a report that by a single oral administration of the bromate salt to rats, mice, and hamsters, at a dose in the vicinity of 280-495 mg/kg within the range for Category 2, ataxia, tachycardia, hypothermia, diarrhea, lacrimation, and piloerection were observed, and at necropsy, hyperemia of the stomach, congestion of the lungs, and renal tubular damages including necrosis in the proximal tubular epithelia were observed (EHC 216 (2000)). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
No information on humans is available. As for experimental animals, there were tests with two strains of transgenic mice (p53 deficient mice, or Tg. AC mice), and differences were observed depending on the strains. In the Tg. AC mice, in a 27-week toxicity test in dosing by drinking water, nephropathy at or above 80 mg/L (male: 13 mg/kg/day, female: 15 mg/kg/day), which is within the guidance value range for Category 2, and decrease in hematocrit value, hemoglobin concentration, and erythrocyte counts, decreases in mean hemoglobin amount and concentration of erythrocytes, increased reticulocyte counts, hypertrophy of the thyroid follicular cells, decreased follicular secretion of the thyroid gland, lymphocyte infiltration of the thyroid gland, and hyperplasia of the renal tubules at or above 400 mg/L (males: 63 mg/kg/day, females: 72 mg/kg/day) were observed. Also, in a 43-week drinking water administration toxicity test (hematological examination was not conducted), effects on the thyroid gland were observed within the guidance value range for Category 2. In addition, in a 26-week dermal administration toxicity test, at 64 mg/kg/day or above within the guidance value range for Category 2, hypertrophy of the follicular cells in the thyroid gland, a decrease in the mean hemoglobin concentration of erythrocytes, at 128 mg/kg/day or above, nephropathy, a decrease in the follicle secretion in the thyroid gland, decrease in the hematocrit value, hemoglobin concentration, and the mean hemoglobin amount of erythrocytes, an increase in the reticulocyte count, and proliferation of the hematopoietic cells in the spleen were observed, and in a 39-week dermal administration toxicity test (hematological examination was not conducted), effects on the thyroid gland were observed within the guidance value range for Category 2. On the other hand, in the p53 deficient mice, in the 27- or 43-week drinking water administration toxicity tests, at 800 mg/L (27 week test (male: 74 mg/kg/day, female: 136 mg/kg/day), 43-week test (male: 65 mg/kg/day, female: 107 mg/kg/day)) which is the maximum dose of the test and within or the upper limit of the guidance value range for Category 2, effects other than lower body weight were not observed (NTP GMM 6 (2007)). Similar to this substance, as information on potassium bromate which is a bromate, in a 13-week test with male and female rats dosed by drinking water, at 600 ppm (63 mg/kg/day as bromic acid), increases in AST, ALT, lactate dehydrogenase, alkaline phosphatase, and urea nitrogen in both sexes, and eosinophilic droplets of the proximal renal tubules in males were observed (IRIS (2001), EHC 216 (2000)). In 100-week tests with male rats and male mice dosed by drinking water, urothelial hyperplasia in male rats was observed at or above 6.1 mg/kg/day as bromic acid, and although doses were not described, eosinophilic droplets in the renal tubular epithelium and mineral deposits in the renal papilla were observed. As for mice, no effects other than a decrease in water consumption were observed at the highest dose of 59.6 mg/kg/day (IRIS (2001)). Other than these, in tests in which sodium bromate (males only), potassium bromate (males and females), or potassium bromide (males only) were administered in drinking water to rats, and the accumulation of kidney protein droplets was evaluated by immunohistological staining of alpha 2u-globulin, protein droplets in the kidney were found in males dosed with potassium bromate or sodium bromate, and it was confirmed that they were alpha 2u-globulin (IARC 73 (1999)). As described above, there are tests with two strains of transgenic mice for this substance, but differences were seen depending on the strain, and as for potassium bromate, nephropathy specific in male rats was mainly observed, clear organ toxicity was not observed in mice. Therefore, it was classified as "Classification not possible." Besides, since the data on the specific transgenic mice alone were not adopted as evidence of the classification, the classification result was different from the previous classification. |
| 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 96-hour LC50 = 36.3 mg/L [converted value, bromate level: 30.8 mg/L] for fish (Morone saxatilis) (NLM HSDB: 2009), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 |
P273
P501 |
Chronic toxicity data were not obtained. Although the behavior in environment is unknown as an inorganic compound, due to acute toxicity Category 3, 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. |