NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	10332-33-9
Chemical Name	Sodium perborate monohydrate
Substance ID	m-nite-10332-33-9_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	- -	-	-	Although this substance contains a chemical group (adjacent oxygen atoms) associated with explosive properties, this substance is classified as Division 5.1, PG III in UNRTDG (UN3377).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid at room temperature (IMDG (2008)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid at room temperature (IMDG (2008)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid at room temperature (IMDG (2008)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid at room temperature (IMDG (2008)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified	- -	-	-	Not combustible (ICSC (2004))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Although this substance contains a chemical group (adjacent oxygen atoms) associated with explosive properties, this substance is classified as "Not applicable" because this substance is classified as an oxidizing substance.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid at room temperature (IMDG (2008)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	Not combustible (ICSC (2004))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Not combustible (ICSC (2004))	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Although it contains a metalloid (B) in the molecule, its water solubility is 15 g/L (20 degC) (EHC 204 (1998)), and it is considered that the substance doesn't react strongly with water.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid at room temperature (IMDG (2008)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Category 3	Warning	H272	P370+P378 P210 P220 P280 P501	This substance is classified as Division 5.1, PG III in UNRDG (UN3377).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	The three LD50 values for rats (1120, 1600 - 2100 and 3250 - 3500 mg/kg) were documented (PATTY, 5th (2001)), and the data corresponds to Category 4, Category 4 or "Not classified", and "Not classified" category, respectively. Selecting the category of greater hazard, the substance was classified as Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rat LD50 value of > 2000 mg/kg (PATTY, 5th (2001)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 or "Not classified" in the UN-GHS classification).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid at room temperature (IMDG (2008)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	The rat LC50 value of 1164 mg/m3/4hrs was documented (HERA (2002)) as the tetrahydrate. Based on its converted LC50 value of 755 mg/m3/4hrs calculate from molecular weight as a monohydrate, the substance was classified as Category 3. As the particle diameter information was reported, it was judged that the test was carried out under dust condition.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	In the Draize test using rabbits, the substance was not irritating (PATTY, 5th (2001)). Also, in another test using rabbits (OECD TG), the substance was documented to be slightly irritating (PATTY, 5th (2001)). Based on these documents, the substance was classified as "Not classified" in the JIS classification (corresponding to Category 3 or "Not classified" in the UN-GHS classification).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In the rabbit test, severe irritating was reported (PATTY, 5th (2001)). Also in other rabbit tests, severe irritating (cornea opacity, iritis, conjunctivae redness, chemosis) was reported in one of 3 animals, and symptoms were not disappeared completely in 21 days (HERA (2002)). Based on these documents, the substance was classified as Category 1. For further information, the substance was classified as "Xi; R41" in the EU classification (EU-Annex 1 (Access on May 2010)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	In the Buehler test for skin sensitization using guinea pigs, one of 10 test group animals as well as one of 10 control group animals showed a slight erythema (10% of animals positive with the administrated group and the control group), and the test substance was not skin sensitizing in this test. It was concluded that sodium perborate hydrates were not sensitized to skin in an appropriate animal test (HERA (2002)). However, since it was the datum from the information source in the "List 2" of the GHS classification guidance for the Japanese government, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Because no in vivo test data available, the classification was not possible. As relevant information, as for in vitro study, positive results in the chromosomal aberration test using cultured mammalian cells (CHO-K1 cells) were reported (HERA (2002)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In the test in which pregnant rats were orally administered the sodium perborate tetrahydrate during the organogenetic period, a statistically significant increase in resorptions, statistically significant increases in visceral malformations and skeletal and visceral anomalies were observed at the dose level where apparent general toxic effects containing reduction in the body weight gain and reduction in food intake of dams were observed (HERA (2002)). Therefore, the substance was classified as Category 2. In addition, the substance was classified as "Category 2; R61" and "Category 3; R62"in the EU classification (EU-Annex I (Access on May 2010)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	The classification was not possible due to lack of sufficient data. As relevant information, it was reported, in the acute oral toxicity study in rats, that abdominal distention and diarrhea (HERA (2002)), dilation of the gastrointestinal tract as typical histopathological finding were observed (HERA (2002)). It was also reported in dogs that emesis occurred after oral administration (PATTY, 5th (2001)). Because it was considered that the symptoms of gastrointestinal tract was probably due to liberation of oxygen from hydrogen peroxide and subsequent irritation in the stomach (PATTY, 5th (2001), HERA (2002)), these findings were excluded from a ground for the classification.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the 28-day oral dose study in rats administered at the highest limit dose level of 1,000 mg/kg/day, the effects observed were as follows: salivation (the only treatment-related clinical sign), reductions in body weight gain and food consumption, decreases in absolute organ weights, reduced spleen size at autopsy, significant decrease in WBC count associated with the involution of spleen parenchyma in microscopic observation, and the effects on gastric mucosa, etc. (HERA (2002)). However, all the changes associated with hematology were considered to be of less significant toxicologically, which led to a conclusion that the NOAEL for systemic toxicity was determined to be ca. 1,000 mg/kg/day (HERA (2002)). Although the classification of this endpoint corresponded to "Not classified" in an oral route, it was conclusively determined as "Classification not possible" due to no data or lack of sufficient data on the other routes.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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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