NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	7440-42-8
Chemical Name	Boron
Substance ID	m-nite-7440-42-8_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	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)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	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)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Inorganic substance contanining no oxygen or halogen. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic substance. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	Not classified	- -	-	-	There are no chemical groups associated with explosive properties. It was classified as "Not classified."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	[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))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[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)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	[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)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[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)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	[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)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	[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)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	[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)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[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.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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