NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	27083-27-8
Chemical Name	Polyhexamethylenebiguanide
Substance ID	m-nite-27083-27-8_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
7	Flammable solids	Not classified	- -	-	-	Not flammable (ECHA (2011)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Pyrophoric solids	Not classified	- -	-	-	It did not ignite after heating at up to 400 deg C (ECHA (2011)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It did not ignite after heating at up to 400 deg C (ECHA (2011)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It does not contain fluorine or oxygen but contains chlorine, which is a chlorine ion and does not contribute to oxidization.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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	It was classified in Category 4 from LD50 = 549 mg/kg (males) and LD50 = 501 mg/kg (females) for rats (ECHA (2011)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" from LD50 > 5,000 mg/kg for rats (ECHA (2011)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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)).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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."	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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).	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2013	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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