Item | Information |
---|---|
CAS RN | 27083-27-8 |
Chemical Name | Polyhexamethylenebiguanide |
Substance ID | 25A0001 |
Classification year (FY) | FY2013 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
New/Revised | New |
Classification result in other fiscal year | |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | GHS Classification Guidance by the Japanese Government (July, 2013) |
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 | 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 solid | Not classified |
- |
- | - | Not flammable (ECHA (2011)). |
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 did not ignite after heating at up to 400 deg C (ECHA (2011)). |
11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It did not ignite after heating at up to 400 deg C (ECHA (2011)). |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition) |
14 | Oxidizing solids | Not applicable |
- |
- | - | It does not contain fluorine or oxygen but contains chlorine, which is a chlorine ion and does not contribute to oxidization. |
15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 4 |
Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
It was classified in Category 4 from LD50 = 549 mg/kg (males) and LD50 = 501 mg/kg (females) for rats (ECHA (2011)). |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | It was classified as "Not classified" from LD50 > 5,000 mg/kg for rats (ECHA (2011)). |
1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Category 1 |
Danger |
H330 |
P304+P340
P403+P233 P260 P271 P284 P310 P320 P405 P501 |
It was classified in Category 1 from LD50 = 0.03 mg/L (converted 4-hour equivalent value) for rats (ECHA (2011)). |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | Three primary skin irritation tests with rabbits (OECD TG404) are reported in ECHA (2011). The mean erythema scores 24 and 72 hours after the application of this substance were 1.0, 2.0, 0 for each test, the mean edema scores were 0.2, 0.0, 0, and all the skin reactions disappeared within 7 days after the application. Besides, this substance is classified in "Xi; R37/38" in EU DSD classification though in a proposed stage. Furthermore, it is concluded in ECHA (2011) that this substance is not a skin irritant based on the results above. It was classified as "Not classified" from the information above. |
3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 |
P305+P351+P338
P280 P310 |
Two eye irritation/corrosion tests with rabbits (OECD TG405) are reported in ECHA (2011). In one of them, corneal opacity, slight conjunctival irritation and vascularization were observed, and these symptoms did not fully disappear 21 days after the application of this substance. In the other test, ulcers on the nictitating membranes and cornea were found 1 day after the application of this substance. Because these symptoms and their severities remained more than 72 hours, they were judged to be irreversible, and the test was stopped. It is concluded in ECHA (2011) that this substance is thought to cause severe irritation to rabbit eyes due to irreversible lesions. Furthermore, this substance is classified in "Xi; R41" in EU DSD classification, and in "H318, Eye dam.1" in EU CLP classification though in a proposed stage. It was classified in Category 1 from the information above. |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
Two skin sensitization test with guinea pigs (OECD TG406, maximization tests) are reported in ECHA (2011). In one of them, severe sensitization was observed by the application of a 20% aqueous solution of this substance. However, in the other test, no sensitization was observed by the application of a 20% aqueous solution of this substance. It is concluded in ECHA (2011) that the positive result in the animal test indicates that this substance is a skin sensitizer. Furthermore, this substance is classified in "Xi; R43" in EU DSD classification, and "H317" in EU CLP classification though in a proposed stage. It was classified in Category 1 from the information above. |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. As for in vivo, it was negative in a micronucleus test with mouse bone marrow and an unscheduled DNA synthesis test with rat hepatocytes (ECHA (2011)). As for in vitro, it was negative in a bacterial reverse mutation test and a chromosomal aberration test with human lymphocytes (ECHA (2011)). There are no other test data to judge germ cell mutagenicity. |
6 | Carcinogenicity | Category 2 |
Warning |
H351 |
P308+P313
P201 P202 P280 P405 P501 |
In carcinogenicity tests with mice by oral or dermal administration, mainly at the doses above MTD (maximum tolerated dose), tumors (such as hemangioma/hemangiosarcoma) were observed, vascular tumors in the liver were dose-dependent, and an increased incidence of tumors was seen from the mid-doses below the MTD. On the other hand, there was no evidence of carcinogenicity in a carcinogenicity test with rats. Evidence was not thought to be strong enough to classify it in Category 1B in this assessment, and it was classified in Category 2. The Committee for Risk Assessment (RAC) of ECHA judged that it is not appropriate to classify it in Category 1B because it is a positive result for carcinogenicity only in one species and classified it in Category 2 (ECHA (2011)), therefore it was classified in Category 2 also in this assessment. |
7 | Reproductive toxicity | Not classified |
- |
- | - | In two-generation and three-generation tests with rats by the oral route, reproductive toxicity was not found by the maximum dose (200 mg/kg/day) (ECHA (2011)). Furthermore, in developmental toxicity tests with rats or rabbits orally dosed during the organogenesis period, at the dose where marked general toxicity occurred (such as death (4/20 animals), decreased body weight gain) in maternal animals, clear developmental toxicity effects were not seen in fetuses (ECHA (2011)). Therefore, it was classified as "Not classified." |
8 | Specific target organ toxicity - Single exposure | Category 1 (respiratory organs) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
In a repeated inhalation exposure test with rats, the animals developed severe nasal irritation and dyspnea and died within 24 hours after a single exposure to the dose that was extremely lower than the guidance value for Category 1 (ECHA (2011)). It was classified in Category 1 (respiratory organs) based on the above data. |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs, blood) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
In oral administration tests with dogs and rats, LOAEL values exceeded the upper limit of the guidance value range for Category 2 (ECHA (2011)), and it corresponds to "Not classified." Because LOAEL was not obtained in the dermal route, the classification is not possible. In two 28-day inhalation exposure tests with rats, squamous cell metaplasia in the larynx, tracheal inflammation, bronchitis, pneumonitis, and methemoglobinemia were observed. LOAEL was 0.25-0.257 microg/L (ECHA (2011)), and it corresponds to Category 1. From the above, it was classified in Category 1 (respiratory organs, blood). |
10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
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 the Annexes to the Montreal Protocol. |
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