GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 10043-35-3
Chemical Name Boric acid
Substance ID 25B0047
Classification year (FY) FY2013
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 by the Japanese Government (July, 2013)
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 Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive properties.
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 solid Not classified
-
-
- - Not combustible (ICSC (1994)).
8 Self-reactive substances and mixtures Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable
-
-
- - Solid (GHS definition)
10 Pyrophoric solids Not classified
-
-
- - Not combustible (ICSC (1994)).
11 Self-heating substances and mixtures Not classified
-
-
- - Not combustible (ICSC (1994)).
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.
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition)
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.
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.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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.
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.
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. 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)).
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.
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.
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 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.
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.
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.
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).
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.
10 Aspiration hazard Classification not possible
-
-
- - 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 (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)).
11 Hazardous to the aquatic environment (Long-term) 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.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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.

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