Item | Information |
---|---|
CAS RN | 7632-04-4 |
Chemical Name | Sodium perborate |
Substance ID | R03-C-069-MHLW |
Classification year (FY) | FY2021 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW) |
New/Revised | Revised |
Classification result in other fiscal year | FY2009 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
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 |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | - |
- |
- | - | - |
2 | Flammable gases | - |
- |
- | - | - |
3 | Aerosols | - |
- |
- | - | - |
4 | Oxidizing gases | - |
- |
- | - | - |
5 | Gases under pressure | - |
- |
- | - | - |
6 | Flammable liquids | - |
- |
- | - | - |
7 | Flammable solids | - |
- |
- | - | - |
8 | Self-reactive substances and mixtures | - |
- |
- | - | - |
9 | Pyrophoric liquids | - |
- |
- | - | - |
10 | Pyrophoric solids | - |
- |
- | - | - |
11 | Self-heating substances and mixtures | - |
- |
- | - | - |
12 | Substances and mixtures which, in contact with water, emit flammable gases | - |
- |
- | - | - |
13 | Oxidizing liquids | - |
- |
- | - | - |
14 | Oxidizing solids | - |
- |
- | - | - |
15 | Organic peroxides | - |
- |
- | - | - |
16 | Corrosive to metals | - |
- |
- | - | - |
17 | Desensitized explosives | - |
- |
- | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | - |
- |
- | - | - |
1 | Acute toxicity (Dermal) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Gases) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Vapours) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Dusts and mists) | - |
- |
- | - | - |
2 | Skin corrosion/irritation | - |
- |
- | - | - |
3 | Serious eye damage/eye irritation | - |
- |
- | - | - |
4 | Respiratory sensitization | - |
- |
- | - | - |
4 | Skin sensitization | - |
- |
- | - | - |
5 | Germ cell mutagenicity | - |
- |
- | - | - |
6 | Carcinogenicity | - |
- |
- | - | - |
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)). |
8 | Specific target organ toxicity - Single exposure | - |
- |
- | - | - |
9 | Specific target organ toxicity - Repeated exposure | - |
- |
- | - | - |
10 | Aspiration hazard | - |
- |
- | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | - |
- |
- | - | - |
11 | Hazardous to the aquatic environment Long term (Chronic) | - |
- |
- | - | - |
12 | Hazardous to the ozone layer | - |
- |
- | - | - |
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