GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 7440-42-8
Chemical Name Boron
Substance ID R01-B-091
Classification year (FY) FY2019
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) 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 *
-
-
- - There are no chemical groups associated with explosive properties. It was classified as "Not classified (Not applicable)."
2 Flammable gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3 Aerosols *
-
-
- - Not aerosol products. It was classified as "Not classified (Not applicable)."
4 Oxidizing gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5 Gases under pressure *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6 Flammable liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7 Flammable solids *
-
-
- - No data available.
8 Self-reactive substances and mixtures *
-
-
- - There are no chemical groups associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9 Pyrophoric liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10 Pyrophoric solids *
-
-
- - It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 580 deg C (HSDB (Access on October 2019)).
11 Self-heating substances and mixtures *
-
-
- - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases *
-
-
- - It is a metalloid (B), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from information that it is insoluble in water (HSDB (Access on October 2019)). Besides, there is information that it is stable in water at normal temperatures, but it generates hydrogen in water vapor of high temperatures to form boric acid (CAS RN 10043-35-3) (Encyclopedia Chimica (Kyoritsu Shuppan Co., Ltd., 2006)).
13 Oxidizing liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14 Oxidizing solids *
-
-
- - Inorganic substance contanining no oxygen or halogen. It was classified as "Not classified (Not applicable)."
15 Organic peroxides *
-
-
- - Inorganic substance. It was classified as "Not classified (Not applicable)."
16 Corrosive to metals *
-
-
- - Classification is not possible because test methods applicable to solid substances are not available.
17 Desensitized explosives *
-
-
- - There are no chemical groups associated with explosive properties. It was classified as "Not classified."

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified." Besides, since the source of the information on the basis in the previous classification was RTECS, and the original source could not be confirmed, the category was changed based on the new information.

[Evidence Data]
(1) LD50 for rats: >2,000 mg/kg (REACH registration dossier (Access on October 2019))
1 Acute toxicity (Dermal) *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) *
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1 Acute toxicity (Inhalation: Vapours) *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) LC50 (4 hours, aerosol) for rats: >5.08 mg/L (REACH registration dossier (Access on October 2019)).
2 Skin corrosion/irritation *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) In a skin irritation test with rabbits according to OECD TG 404, all of the mean scores at 24/48/72 hours were 0 (REACH registration dossier (Access on November 2019)).
3 Serious eye damage/eye irritation *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) In an eye irritation test according to OECD TG 405, all of the mean scores for the cornea, iris, conjunctival redness and chemosis at 24/48/72 hours were 0 (REACH registration dossier (Access on November 2019)).
4 Respiratory sensitization *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) In a mouse Local Lymph Node Assay (LLNA) according to OECD TG 429, the SI value was less than 3, and it was judged as negative (REACH registration dossier (Access on November 2019)).
5 Germ cell mutagenicity *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
6 Carcinogenicity *
-
-
- - [Rationale for the Classification]
Based on classification results by other organizations in (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) As for classification results by domestic and international organizations, based on the 1999 draft guidelines, the EPA stated in the assessment for boron and boron compounds that the data are "inadequate for an assessment of human carcinogenic potential for boron" (IRIS (2004)).

[Reference Data, etc.]
(2) In a study in which mice were given boric acid (CAS RN 10043-35-3) by feeding for 2 years, no increase in the incidence of tumours was noted (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012)).
(3) In humans, there were no reports of suspected carcinogenicity associated with increased exposure to boron from the diet or environment, rather on the contrary, there were reports suggesting a reduced incidence of prostate cancer (Environmental Risk Assessment for Chemical Substances Vol.14 (Ministry of the Environment, 2016)).
7 Reproductive toxicity *
-
-
- - [Rationale for the Classification]
This classification was targeted for classification boron as a metalloid. Based on (1), there was a description that it was known to show reproductive effects in experimental animals. However, this was based on data on boric acid (CAS RN 10043-35-3) and borax (CAS RN 1330-43-4).
Based on (3), since this substance was insoluble in water and hydrochloric acid, it was considered to be inappropriate to classify it based on data for water-soluble boron compounds such as boric acid and borax. Therefore, it was classified as "Classification not possible" due to lack of data.

[Reference Data, etc.]
(1) In experimental animals, boron was reported to cause testicular toxicity and developmental toxicity (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012)).
(2) In epidemiological studies, reproductive effects in men exposed to high concentrations of boron via the working environment or drinking water were investigated, and there were data suggesting an effect on the male-female ratio. However, no results were obtained that clearly showed the reproductive effects of boron (Risk Assessment Report (Beverages) (Food Safety Commission of Japan, 2012)).
(3) Boron was insoluble in water and hydrochloric acid (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)).
8 Specific target organ toxicity - Single exposure Category 2 (respiratory organs)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
[Rationale for the Classification]
There was no information on single exposure in humans. Based on the information in experimental animals in (1), it was classified in Category 2 (respiratory organs). The classification result was changed from the previous classification by the use of the new information source.

[Evidence Data]
(1) In a single 4 hour-inhalation exposure test with rats, when the aerosol concentration of this substance (amorphous boron) was at 5.08 mg/L (concentration slightly exceeding the upper limit of Category 2), respiratory noise and deep respiration were observed during and immediately after exposure and Days 2 and 4, but there were no unscheduled deaths. A brown discoloration and congestion were noted on the lungs at necropsy performed after 14 days (REACH registration dossier (Access on October 2019)).
9 Specific target organ toxicity - Repeated exposure *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

[Reference Data, etc.]
(1) When mice were exposed by inhalation to this substance at a concentration of 72.8 mg/m3 for 30 days (7 hours/day, 5 days/week), boron was detected in the lungs, liver, kidneys and gastrointestinal tract, but no effects were seen (PATTY (6th, 2012)).
(2) When mice and rats were exposed by inhalation to the dust of this substance at concentrations of 12 and 170 mg boron/m3 for 4 months (4 hours/day, 6 days/week), changes in the liver function parameters and histological changes in the lungs, liver, brain and kidneys were noted (GESTIS (Access on September 2019)).
(3) When rats were exposed by inhalation to the dust of this substance at concentrations of 1.7 and 10.56 mg boron/m3 for 4 months (4 hours/day), at 10.56 mg boron/m3, reduced body weight gain, decreased numbers of erythrocytes, increased excitability to the central nervous system, stronger heart action, changes to the lung tissue (thickening of the alveolar walls and polymorphonuclear infiltrations) and a gonadotropic effect (decreased osmotic resistance of the sperm and an increased number of seminal tubules with peeled epithelium) were observed (GESTIS (Access on September 2019)).
(4) Borax (sodium tetraborate) (CAS RN 1330-43-4) was classified in Category 1 (respiratory organs), Category 2 (genetic organs (men)) in the FY 2017 GHS classification project.
10 Aspiration hazard *
-
-
- - [Rationale for the Classification]
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 Short term (Acute) Classification not possible
-
-
- - Classification not possible due to lack of data.
11 Hazardous to the aquatic environment Long term (Chronic) Classification not possible
-
-
- - Classification not possible due to lack of data.
12 Hazardous to the ozone layer Classification not possible
-
-
- - Classification not possible due to lack of data.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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