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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	9016-87-9
Chemical Name	Polymethylenepolyphenylene isocyanate
Substance ID	R02-A-013-METI
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
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 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)
Model SDS by MHLW (External link)
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	Information was obtained, and a flash point is estimated to exceed 93 deg C in the prescribed closed-cup method. Therefore, it was classified as "Not classified."
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 400 deg C (GESTIS (Accessed Sep. 2020)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats (males): > 10,000 mg/kg (REACH registration dossier (Accessed Oct. 2020))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rabbits: > 9,400 mg/kg (REACH registration dossier (Accessed Oct. 2020), AICIS (formerly, NICNAS IMAP) (2013))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1). [Evidence Data] (1) LC50 for rats (4 hours): 0.49 mg/L (aerosol) (REACH registration dossier (Accessed Oct. 2020), AICIS (formerly, NICNAS IMAP) (2013), DFG MAK (1992))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) This substance causes itching erythema in direct contact with the human skin (DFG MAK (1992)). (2) It is reported that slight erythema and coriaceousness were observed after occlusive application of undiluted this substance to rabbits (HSDB (Accessed Oct. 2020)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] It was classified in Category 2 from (1) (2) in accordance with the GHS classification guidance for the Japanese government. [Evidence Data] (1) Transient blepharo-conjunctivitis is observed after direct contact of the eyes with PMDI in humans (DFG MAK (1992)). (2) It is reported that short-term exposure to this substance can cause irritation of the eyes and respiratory tract (DFG MAK (2008)).
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	[Rationale for the Classification] It was classified in Category 1 from (1) - (3) in accordance with the GHS classification guidance for the Japanese government. [Evidence Data] (1) A few cases of exogenic allergic alveolitis (hypersensitivity pneumonitis) were reported in persons exposed to this substance. Occasionally, the symptoms of alveolitis were associated with asthmatic symptoms (DFG MAK (1992)). (2) Both this substance and its monomer, MDI, cause allergies of the respiratory passages (DFG MAK (2000)). (3) It was classified as Sah (sensitizing substances to the airway and skin) in DFG MAK.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 from (1) in accordance with the GHS classification guidance for the Japanese government. Besides, knowledge in (2) was not used for classification because the details are unknown. [Evidence Data] (1) It was classified as Sah (sensitizing substances to the airway and skin) in DFG MAK. [Reference Data, etc.] (2) It was negative in a maximization test with guinea pigs (DFG MAK (1992)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (2), it was classified in Category 2. [Evidence Data] (1) As for classification results by domestic and international organizations, this substance was classified in Group 3 by IARC, "not classifiable or a Group D chemical (under the 1986 guidelines)" or "cannot be determined, but for which there is suggestive evidence that raises concern for carcinogenic effects (under the 1996 guidelines)" by EPA (IRIS (1998), and DFG MAK classified as Category 3B (DFG MAK (2015)). (2) In a carcinogenicity study by two-year inhalation exposure with rats, pulmonary adenomas in 6/60 males and 2/60 females and pulmonary adenocarcinomas in 1/60 males were observed at the highest concentration of 6.0 mg/m3 (DFG MAK (2008), IRIS (1998), AICIS (previous NICNAS) IMAP (2013)). [Reference Data, etc.] (3) After long-term exposure of rats to this substance, preneoplastic and neoplastic changes were observed in the lungs. A mechanism of tumor formation by cell proliferation associated with chronic inflammation was assumed (DFG MAK (2008)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) It was reported that in a developmental toxicity study by inhalation exposure to PMDI tested with rats (6 to 15 gestation days, 6 hours/day), apparent general toxicity effects (2/24 deaths, reduced body weight gain, decreased liver weight, increased lung weight) in parental animals and developmental effects (reduced fetal and placental weights, increased incidences of skeletal variations and skeletal retardations) in pups were observed at 0.012mg/L (DFG MAK (2008)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1 (respiratory organs). [Evidence Data] (1) It was reported that short-term exposure to this substance could cause irritation of the eyes and respiratory tract (DFG MAK (2008)). (2) It was reported that the aerosol mixture of this substance being used to apply an insulator to the insides of railway carriages was blown by the wind, a group of 12 workers standing 20 to 40 meters away was exposed to the mixture, and within two hours, all twelve developed symptoms such as pain behind the eyes, nasal discharge, retrosternal soreness, constriction of the chest, coughing and headaches. The symptoms regressed within a few days (DFG MAK (1992)). (3) It was reported that in an acute inhalation (vapor) exposure test with rats (for four hours), in the 0.384 mg/L and 0.523 mg/L (within the range for Category 1) groups, labored breathing and mouth breathing during the exposure were observed, some hemorrhages in the lungs and hemorrhagic fluid around the noses were observed in a few animals that died, and the lungs of most animals in the highest dose group were grayish white and wet (REACH registration dossier (Accessed Oct. 2020), NICNAS IMAP (2013), DFG MAK (1992)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1 (respiratory organs). [Evidence Data] (1) According to a report on repeated exposure effects in humans, an impairment of lung function was observed at the PMDI (polymeric methylene diphenyl diisocyanate) concentration of as low as 87 ppb (0.9 mg/m3); at the concentration of 20 ppb (0.2 mg/m3), no changes in lung spirometry were found, although airway symptoms occurred; and after exposure to the PMDI concentration of below 10 ppb (0.1 mg/m3), the frequency of respiratory complaints did not significantly increase (DFG MAK (2008)). (2) It was reported that in a 13-week inhalation exposure test with rats (aerosol, 6 hours/day, 5 days/week), an increase in alveolar macrophages, interstitial macrophage infiltration and macrophages with yellowish inclusions in the lungs in the mediastinal lymph nodes were observed at 4.1 mg/m3 and above (converted guidance value: 0.0029 mg/L, within the range for Category 1), damages to the olfactory epithelium and basal cell hyperplasia in the nasal cavity were observed at or above 8.4 mg/m3 (converted guidance value: 0.0059 mg/L, within the range for Category 1), and reduced body weight gain was observed and 11/30 males and 4/30 females died of severe respiratory failure at 12.3 mg/m3 (converted guidance value: 0.0088 mg/L, within the range for Category 1) (DFG MAK (1992)). (3) It was reported that in a two-year inhalation exposure test with rats (aerosol, 6 hours/day, 5 days/week), effects on the nasal cavity (degeneration and basal cell hyperplasia of the olfactory epithelium, hyperplasia of Bowman's gland), the lungs (increase in alveolar macrophages, localized fibrosis, epithelialization of the alveolar duct) and the mediastinal lymph node (macrophages with yellowish inclusions) were observed at 1.0 mg/m3 and above (0.001 mg/L, within the range for Category 1) (DFG MAK (2008), AICIS (previous NICNAS) IMAP (2013), REACH registration dossier (Accessed Oct. 2020)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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