NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	7632-04-4
Chemical Name	Sodium perborate
Substance ID	m-nite-7632-04-4_v2
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	- -	-	-	The substance is classified into Division 5.1 (Oxydizing substances), PG II in UNRTDG (UN3247) though there are chemical groups (-O-O-) associated with explosive properties present in the molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Not classified	- -	-	-	Information is available that sodium perborate tetrahydrate (10486-00-7) is not combustible (ICSC (J) (2004)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	The substance is classified into Division 5.1 (Oxidizing substances), PG II in UNRTDG (UN3247) though there are chemical groups (-O-O-) associated with explosive properties present in the molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Not classified	- -	-	-	The substance does not fall into upper Division 4.2, PG I since it is classified into Division 5.1 (Oxidizing substances), PG II in UNRTDG (UN3247).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Information is available that sodium perborate tetrahydrate (10486-00-7) is not combustible (ICSC (J) (2004)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Substances and mixtures which, in contact with water, emit flammable gases	Classification not possible	- -	-	-	Classification is not possible since no data are available though the substance contains metals (Na) and metalloids (B).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Category 2	Danger	H272	P370+P378 P210 P220 P280 P501	Classified into Category 2 since the anhydrite is classified into Division 5.1, PG II in UNRTDG (UN3247). Monohydrate is classified into Category 3 since it is classified into Division 5.1, PG III in UNRTDG (UN3377).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Inorganic compound	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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	Due to lack of data for sodium perborate, data for sodium perborate tetrahydrate (CAS: 10486-00-7) or sodium perborate monohydrate (CAS: 10332-33-9) are used as the basis of classification. Anhydride equivalent LD50 values are 1120 mg/kg and 1200 mg/kg when sodium perborate tetrahydrate was administered to rats (PATTY (5th, 2001)) or 920 mg/kg, 1470 - 1720 mg/kg, 3000 mg/kg (male) and 2700 mg/kg (female) when sodium perborate monohydrate was administered to rats (PATTY (5th, 2001)). The substance was classified into Category 4 since many LD50 values are in this category. Anhydride equivalent LD50 values are reported to be 1120 mg/kg and 1200 mg/kg when sodium perborate tetrahydrate was administered to rats (PATTY (5th, 2001)) or 920 mg/kg, 1470 - 1720 mg/kg, 3000 mg/kg (male) and 2700 mg/kg (female) when sodium perborate monohydrate was administered to rats (PATTY (5th, 2001)). The substance was classified as Category 4 because many LD50 values are in this category.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data. As relevant information, a LD50 value of sodium perborate monohydrate is >2000 mg/kg for rabbits (PATTY (5th, 2001)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Sodium perborate tetrahydrate is solid (GHS definition).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Although a LC50 value of sodium perborate tetrahydrate is reported to be >0.074 mg/L for rats (EHC 204 (1998)), the exposure period was not clear.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on a report that the substance was classified as not irritating in rat Draize tests where 500 mg of sodium perborate tetrahydrate or monohydrate was applied for 4-hour (PATTY (5th, 2001)) and a report that slight irritation was observed after application of sodium perborate tetrahydrate monohydrate to rabbits (PATTY (5th, 2001)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 or "Not classified" in GHS classification).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	Based on a report of severely irritating after application of sodium perborate tetrahydrate powder to rabbits (PATTY (5th, 2001)) and a report of severely irritating after application of sodium perborate monohydrate powder to rabbits (PATTY (5th, 2001)), and classification as Xi; R41 in EU classification (EU-Annex I (access on Aug. 2009)), the substance was classified into Category 1.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data from in vivo mutagenicity tests. From in vitro mutagenicity tests, there are reports of a positive Ames test and a positive chromosomal aberration test (HSDB (2006)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), since malformations were observed in fetuses at the dose at which no maternal toxicity was observed, it was classified in Category 1B. Based on the new information source, the category was changed. [Evidence Data] (1) It was reported that, in a prenatal developmental toxicity study (OECD TG 414, GLP, 100 to 1,000 mg/kg/day) for sodium perborate tetrahydrate (CAS RN 10486-00-7) used as a test substance with pregnant rats dosed by gavage (days 6 to 15 of gestation), at the low dose (100 mg/kg/day) at which no maternal toxicity was observed, external malformations (ablepharia (5 animals), acrania (6 animals), exencephaly (6), exophthalmia (3), macroglossia (6), cleft palate (5), cleft lip (2), facial cleft (1)) and visceral malformations (convoluted ureter) were observed in fetuses, and at the mid and high doses (300 and 1,000 mg/kg/day) at which maternal toxicity (decreased body weight/reduced body weight gain) was observed, a decrease in the number of live fetuses (at or above the mid dose), such as an increase in post-implantation losses, malformations (fused ribs), cardiovascular malformations (vascular ring, displaced or double aortic arch, displaced botallus duct), malformations of the eyes (anophthalmia, microphthalmia), enlarged lateral ventricles of the brain, absence of renal papillae were observed in the high-dose group (CLH Report (2021), AICIS (previous NICNAS) IMAP (2018), SCCS (2010), EU RAR (2007)). [Reference Data, etc.] (2) Since the malformations induced at the highest dose of 1,000 mg/kg/day of sodium perborate tetrahydrate were similar to those induced by boric acid (CAS RN 10043-35-3) in other experiments, this substance was also suggested as having embryotoxic effects due to the release of boron. It was also agreed that, based on the pattern of malformations, both chemicals (this substance and boric acid) have developmental effects, with slightly different mechanisms based on different kinetics following administration (AICIS (previous NICNAS) IMAP (2018), EU RAR (2007)). (3) In the EU, both this substance and boric acid were classified in Repr. 1B (EU CLP Classification Results (Accessed Dec. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is information that the lowest concentration causing respiratory irritation in rat was 39 mg/m3 (PATTY (5th, 2001)), however, the details are not clear. The substance is classified into Xi; R37 in EU classification (EU-Annex I (access on Aug. 2009)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is a report that in a 28-day test in rat given sodium perborate tetrahydrate at an oral dose of 1000 mg/kg/day (90-day equivalence: 311 mg/kg/day), histological changes in the stomach were observed that are probably attributable to the formation of hydrogen peroxide in the stomach (PATTY (5th, 2001)). In addition, there is a report that repeated oral use as a mouthwash or the ingestion of tablets and powders marketed as denture cleansers has caused injuries (HSDB (2006)). The information is not used as the basis of classification for specific target organ toxicity since they are considered to be effects by site of contact.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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