NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1303-86-2
Chemical Name	Diboron trioxide
Substance ID	m-nite-1303-86-2_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 present in the molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is not combustible (GESTIS (Access on May 2017)).	FY2017	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 present in the molecule associated with explosive or self-reactive properties.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (GESTIS (Access on May 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (HSDB (Access on May 2017)).	FY2017	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 contains metalloids (B), but it is estimated that it does not react vigorously with water from the observation result of being soluble in water (ICSC (J) (2014)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound containing oxygen, but the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic compound.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

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	- -	-	-	Based on a report of an LD50 value of 3,163 mg/kg (ACGIH (7th, 2001), HSDB (Access on May 2017)) for mice, this substance was classified as "Not classified" (Category 5 in UN GHS classification). The category was revised along with the revision of the GHS classification guidance for the Japanese Government.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on a report that erythema appeared in rabbits, but disappeared after a few days (ACGIH (7th, 2001), DFGOT Vol. 13 (1999), ECETOC TR63 (1995)), it was judged as slight irritation, and this substance was classified as "Not classified" (Category 3 in UN GHS classification). The category was revised along with the revision of the GHS classification guidance for the Japanese Government.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There is a description that effects on the conjunctiva were observed in animals to which this substance was applied (ACGIH (7th, 2001), DFGOT vol. 13 (1999)). In addition, there is a report that 113 workers exposed to this substance and boric acid significantly complained about eye irritation compared with the control group (ACGIH (7th, 2001)). Therefore, this substance was classified in Category 2A.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, please refer to the classification result (Classification not possible) of boric acid (CAS RN 10043-35-3).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	There is no data on this substance itself, but it is considered that information on inorganic boron compounds may be available for the classification of this substance. Inorganic borate compounds (anhydrous sodium borate, sodium borate pentahydrate, sodium borate decahydrate and boric acid) were classified in A4 by ACGIH (ACGIH (7th, 2005)). Therefore, this substance was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	Although there is no information on the reproductive toxicity of this substance itself, it was considered that the information on boric acid (CAS RN 10043-35-3) and borax (Na2B4O7 10H2O, CAS RN 1303-96-4) as boron compounds were available for the classification. In reproductive toxicity tests in which boric acid was administered to mice and boric acid or borax was administered to rats, infertility due to a decrease in fertility was observed at doses at which general toxic effects were not observed in parental animals. As the result of cross-over mating tests, reduced fertility of male mice was the cause of infertility. However, complete infertility was also observed when females of the treated group were mated with males of the control group (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2010)). On the other hand, in multiple developmental toxicity studies in which boric acid was administered by feeding during the organogenesis period of pregnant rats or pregnant mice, an increase in an incidence of malformations (defects and shortening of the 13th ribs, dilatation of the lateral ventricle, etc.), and an increase in fetal mortality and neonatal mortality were observed at the doses where maternal toxicity (reduced body weight gain, decreased food consumption, etc.) was manifested (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ATSDR (2010)). Also in a test in which boric acid was administered by gavage during the organogenesis period of pregnant rabbits, an increase in malformation of the cardiovascular system and an increase in fetal mortality were reported at doses where reduced body weight in maternal animals was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, it was considered that this substance could show reproductive and developmental toxicity similar to boric acid and borax as a boron compound, and it was classified in Category 1B. Besides, EU also classified this substance as "Repr. 1B" (ECHA CL Inventory (Access on May 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	There is a report that in single inhalation exposure studies of boric acid or borax dust in volunteers, a significant increase in nasal secretion was observed compared to the control group (ACGIH (7th, 2005), ATSDR (2010), DFGOT (2013) (Access on May 2017)). Therefore, this substance was classified in Category 3 (respiratory tract irritation). Besides, although the number of exposures is unknown, in interviews with workers who were exposed to this substance or boric acid at the borate manufacturing factory in the US, eye irritation, irritation of the respiratory organs (dryness of nose, mouth, and throat, sore throat, cough, etc.) were reported (ACGIH (7th, 2001), DFGOT Vol. 13 (1999)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In humans, in interviews with workers who were exposed to this substance or boric acid, eye irritation, irritation of the respiratory organs (dryness of the nose, mouth, and throat, sore throat, cough, etc.) were reported (ACGIH (7th, 2001), DFGOT Vol. 13 (1999)). As for experimental animals, in an inhalation toxicity study for 10-24 weeks (6 hours/day, 5 days/week), no effects were observed at 470 mg/m3 (converted guidance value: 0.37 mg/L) exceeding the guidance value range for Category 2. And, in a 23-week inhalation toxicity study (6 hours/day, 5 days/week) with dogs, no effects were observed at 57 mg/m3 (converted guidance value: 0.04 mg/L) within the guidance value range for Category 2 (ATSDR (2010), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol. 14 (Ministry of the Environment, 2016)). Other than these, there is a report that in a 3-week study in which a 10% suspension of this substance in water was administered by gavage to rats, no effects were observed at 500 mg/kg/day (converted guidance value: 83 mg/kg/day), which is within the guidance value range for Category 2 (ACGIH (7th, 2001), Wilding JL et al. (1959) The toxicity of boron oxide. Am Ind Hyg Assoc J. 20: 284-289.). This report was not used for classification because test conditions etc. are inadequate. From the above, because it was unknown whether the effects on the respiratory organs in humans were due to either acute or repeated exposure, and based on the interview, it was considered inadequate to adopt them as evidence for target organs of repeated exposure. Also, although it corresponds to "Not classified" in the test with rats, the highest dose is less than the upper limit of Category 2 in the test with dogs, and the effects at up to the upper limit of Category 2 are unknown. Therefore, it could not be classified as "Not classified," and it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	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)	Not classified	- -	-	-	From 72-hour EC50 (growth inhibition) = 109 mg/L [converted value 34 mgB/L] for algae (Desmodesmus subspicatus) (WHO EHC: 1998), and 96-hour LC50 = 238 mg/L [converted value 73.79 mgB/L] for crustacea (Americamysis bahia) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)), and 96-hour LC50 = 750 mg/L [converted value 233 mgB/L] for fish (Xyrauchen texanus) (WHO EHC:1998), it was classified as "Not classified." Besides, because this substance hydrolyzes to form boric acid in water, the data of boric acid was used for the classification (Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Although the behavior of a metal salt in water is unknown, due to water solubility of 22,000 mg/L, 72-hour EC10 (growth inhibition) = 77 mg/L [converted value 24 mgB/L] for algae (Desmodesmus subspicatus) (WHO EHC: 1998), 21-day NOEC (reproduction, growth) = 19 mg/L [converted value 6 mgB/L] for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)), and 87-day NOEC (survival rate) = 6.8 mg/L [converted value 2.1 mgB/L] for fish (Oncorhynchus mykiss) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)), it was classified as "Not classified." Besides, because this substance hydrolyzes to form boric acid in water, the data of boric acid was used for the classification (Environmental Risk Assessment for Chemical Substances vol. 14 (Ministry of the Environment, 2016)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	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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