NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	10043-35-3
Chemical Name	Boric acid
Substance ID	m-nite-10043-35-3_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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 present in the molecule associated with explosive properties.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Not classified	- -	-	-	Not combustible (ICSC (1994)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Not classified	- -	-	-	Not combustible (ICSC (1994)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (ICSC (1994)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	From information on water solubility: 5.6 g/100 mL (ICSC (1994)), it is recognized that it does not react vigorously with water.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound containing oxygen (but not chlorine), but the classification is not possible due to no data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic compound.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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	- -	-	-	It was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification) based on reports of LD50 values for rats of 2,660-5,140 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), > 4,000 mg/kg (NTP TR324 (1987), ATSDR (2007)), 3,765 mg/kg (EU-RAR (2007)), 2,660 mg/kg (aqueous solution), 5,140 mg/kg (20% aqueous suspension), 3,160 mg/kg (50% aqueous suspension), 3,450 mg/kg (50% aqueous suspension), 4,080 mg/kg (50% aqueous suspension), and 5,000 mg/kg (aqueous suspension) (the last 6 values from DFGOT vol. 5 (1993)). Besides, data in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), NTP TR-324 (1987), EU-RAR (2007) obtained in this investigation were added, and the classification was changed from Category 5 to "Not classified" according to the Classification JIS.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on an LD50 value of > 2,000 mg/kg for rats (EU-RAR (2007)) and an LD50 value of > 2,000 mg/kg for rabbits (EPA Pesticides "Reregistration Eligibility Decision" TRED (2006)). Besides, the classification was conducted based on data in EU-RAR (2007) and EPA Pesticides "Reregistration Eligibility Decision" TRED (2006), which were obtained in this investigation.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, it is reported that 4-hour inhalation exposure to this substance at 2.12 mg/L did not cause death in rats (EU-RAR (2007)), and LCLo for rats was 28 mg/m3/4 hours (0.028 mg/L/4 hours) (DFGOT vol. 5 (1993)). These were regarded to be tests on dust because it is described that the saturated vapour pressure of this substance at 20 deg C is negligible (HSDB (Access on September 2013)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In skin irritation tests with guinea pigs and rabbits in which 5 mL of a 10% aqueous solution of this substance was applied, and the judgment was made after 24 and 72 hours, it is described that irritation was observed in both guinea pigs and rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), and slight to moderate skin irritation was seen (PATTY (4th, 2000), PATTY (6th, 2012)), although it is unknown whether these were 4-hour application tests. Therefore, it was classified in Category 2.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In an eye irritation/corrosion test with six rabbits, washing the eyes 24 hours application of 100 mg of this substance resulted in blisters in the conjunctiva, which disappeared within seven days (IUCLID (2000)). And in the descriptions in health effects in humans in ATSDR (2007), ACGIH (7th, 2005), there are reports that it was irritating, although the intensity and a recovery period are unknown. Therefore, it was classified in Category 2. The classification was revised by using the information newly obtained in this investigation as the rationale.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a micronucleus test with mouse bone marrow cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), EU-RAR (2007), IUCLID (2000), ACGIH (7th, 2005), EPA Pesticide (1994), ECETOC-TR 63 (1995)). As for in vitro, it was all negative in a bacterial reverse mutation test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), EU-RAR (2007), IUCLID (2000), ACGIH (7th, 2005), EPA Pesticide (1994), NTP DB (Access on June 2013)), a gene mutation test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), EHC 204 (1998), IUCLID (2000), ACGIH (7th, 2005), NTP DB (Access on June 2013), EPA Pesticide (1994)) and a chromosomal aberration test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), EHC 204 (1998), EU-RAR (2007), NTP DB (Access on June 2013)) with cultured mammalian cells.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified in A4 (as inorganic borate compounds) in ACGIH (2005) and Group E in IRIS (2004). Among these, IRIS was based on the criteria in 1999, which was old and revised after that. Therefore, by adopting ACGIH, which was newer information, it was classified as "Classification not possible." The category was changed according to the revised GHS classification guidance for the Japanese government.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a continuous breeding test with mice, effects on male fertility were seen, and reduced fertility, sterility, decreased litter size, and decreased body weights of offspring were observed. In a three-generation reproductive toxicity test with rats, testicular atrophy, decreased ovulation, and sterility considered to be caused by effects on female fertility were found (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2005), EHC (1998), DFGOT vol. 5 (1993)). As for developmental toxicity, in a teratogenicity test with rats, decreased fetal body weights, shortening of the 13th ribs, and increased wavy ribs were observed at the dose where no effects were seen in maternal animals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), EHC 204 (1998), ACGIH (7th, 2005), DFGOT vol. 5 (1993), NTP DB (Access on Aug. 2013)). And increased fetal mortality, decreased fetal body weights, and increases in craniofacial malformations (mainly anophthalmia, microphthalmia) and malformations in the central nervous system (mainly ventricular enlargement, hydrocephaly) in rats (NTP DB (Access on Aug. 2013)), and increased fetal mortality and an increase in cardiovascular malformations (mainly ventricular septal defect) in rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), ACGIH (7th, 2005), EHC (1998), NTP DB (Access on Aug. 2013)) were found at the doses that caused maternal toxicity. Therefore, it was classified in Category 1B. Besides, the information source in List 3 in the previous classification was removed, and information sources in List 1 were added.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Specific target organ toxicity - Single exposure	Category 1 (gastrointestinal tract, central nervous system), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	In humans, nausea, vomiting, abdominal pain, diarrhea, depression of the central nervous system, convulsions, and irritation of the respiratory tract are described (ACGIH (7th, 2005), DFGOT vol. 5 (1993)), and in experimental animals, slight irritation of the respiratory tract was observed (ECETOC TR 63 (1995)). From the above, it was classified in Category 1 (central nervous system, gastrointestinal tract), Category 3 (respiratory tract irritation).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There are no reports on repeated exposure effects in humans. As for experimental animals, it is described that in 13-week or 2-year diet administration tests with mice and rats, effects on the testis (atrophy, atrophy of the seminiferous tubules), spleen (increased extramedullary hematopoiesis), and blood system (decreases in hemoglobin and hematocrit) were observed at the doses (equivalent to 150 mg/kg/day or above) above the guidance value range for Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), therefore it corresponds to "Not classified" in the oral route. However, because of no toxicity information on the other routes, it was classified as "Classification not possible" due to lack of data. Besides, in the previous classification, it was classified in Category 1 (kidney) based on data of human cases from the information source in List 3, but the kidney was removed from the target organ because the rationale data to adopt the kidney could not be obtained from the information sources in List 1 and 2 used this time.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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	- -	-	-	It was classified as "Not classified" due to 72-hour ErC50 = 290 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2008)), 48-hour LC50 = 133 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008); Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)), and 96-hour LC50 = 447 mg/L for fish (Oncorhynchus kisutch) (Initial Risk Assessment (NITE, CERI, NEDO, 2008)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	It was classified as "Not classified" due to 87-day NOEC = 2.1 mg/L for fish (Oncorhynchus mykiss) (Initial Risk Assessment (NITE, CERI, NEDO, 2008); Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)), despite unknown behavior of the inorganic compound, this substance in water.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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