GHS Classification Result

Chemical Name：Sodium perborate monohydrate
CAS：10332-33-9

Result：
ID: 22A4018
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
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).
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Solid at room temperature (IMDG (2008)).
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid at room temperature (IMDG (2008)).
5 Gases under pressure Not applicable - - - - Solid at room temperature (IMDG (2008)).
6 Flammable liquids Not applicable - - - - Solid at room temperature (IMDG (2008)).
7 Flammable solids Not classified - - - - Not combustible (ICSC (2004))
8 Self-reactive substances and mixtures 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.
9 Pyrophoric liquids Not applicable - - - - Solid at room temperature (IMDG (2008)).
10 Pyrophoric solids Not classified - - - - Not combustible (ICSC (2004))
11 Self-heating substances and mixtures Not classified - - - - Not combustible (ICSC (2004))
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.
13 Oxidizing liquids Not applicable - - - - Solid at room temperature (IMDG (2008)).
14 Oxidizing solids Category 3 Warning H272: May intensity fire; oxidizer P370+P378: In case of fire: Use ... for extinction.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P220: Keep/Store away from clothing/.../combustible materials.
P221: Take any precaution to avoid mixing with combustibles/...
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ... 		This substance is classified as Division 5.1, PG III in UNRDG (UN3377).
15 Organic peroxides Not applicable - - - - Inorganic compound
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		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.
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).
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid at room temperature (IMDG (2008)).
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Category 3 Danger H331: Toxic if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P311: Call a POISON CENTER or doctor/physician.
P321: Specific treatment （see ... on this label）.
P405: Store locked up. 		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.
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).
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician. 		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)).
4 Respiratory sensitization Classification not possible - - - - No data available.
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".
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)).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		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)).
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.
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.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment （Long-term） Classification not possible - - - - No data available.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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