GHS Classification Result

日本語で表示



GENERAL INFORMATION
Item Information
CAS RN 1303-86-2
Chemical Name Diboron trioxide
Substance ID H29-B-001
Classification year (FY) FY2017
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)  
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 associated with explosive properties present in the molecule.
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 solids Not classified
-
-
- - It is not combustible (GESTIS (Access on May 2017)).
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
-
-
- - It is not combustible (GESTIS (Access on May 2017)).
11 Self-heating substances and mixtures Not classified
-
-
- - It is not combustible (HSDB (Access on May 2017)).
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)).
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition).
14 Oxidizing solids Classification not possible
-
-
- - It is an inorganic compound containing oxygen, 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
-
-
- - 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.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data.
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.
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.
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.
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
-
-
- - 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).
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."
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)).
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)).
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."
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
-
-
- - 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)).
11 Hazardous to the aquatic environment (Long-term) 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)).
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

To GHS Information