GHS Classification Result

日本語で表示



GENERAL INFORMATION
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

REFERENCE INFORMATION
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

PHYSICAL HAZARDS
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.

HEALTH HAZARDS
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.

ENVIRONMENTAL HAZARDS
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.


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.

To GHS Information