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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	5124-30-1
Chemical Name	Methylenebis(4,1-cyclohexylene) diisocyanate
Substance ID	H26-B-105, R-048
Classification year (FY)	FY2014
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition)
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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" based on a flash point of 200 deg C (unknown test methods) (SIDS (2007)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	Isocyanate is a cyanate in a broad sense. It easily polymerizes, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 225 deg C (SIDS (2007)).
10	Pyrophoric solids	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 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	- -	-	-	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 applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	Based on a report of an LD50 value of 9,900 mg/kg for rats (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), SIDS (2007), ACGIH (7th, 2001)), it was classified as "Not classified."
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of >10,000 mg/kg for rabbits (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), SIDS (2007), ACGIH (7th, 2001)), it was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Data of guinea pigs in the previous classification was determined not to be adopted according to the GHS Classification Guidance for the Japanese Government, and the category was revised.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on a report of an LC50 value (4 hours) (OECD TG 403) of 0.434 mg/L for rats (SIDS (2007)), it was classified in Category 2. Besides, there is a description that the test was conducted by aerosol, and the LC50 value was higher than the saturated vapor concentration (0.002 ppm), therefore, the reference values as a mist were applied. Since a new information source (SIDS (2007)) was added, the category was revised.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In 2 skin irritation tests (OECD TG 404) with rabbits, since edema and erythema were observed, and primary irritation scores were 4.2 and 3.6, respectively, it was judged as moderate irritation (SIDS (2007)). In addition, although there are reports that severe skin irritation was observed in a skin irritation test with rabbits and that severe erythema and edema were observed in a skin irritation test with guinea pigs, there was no description of the recovery (ACGIH (7th, 2001)). Based on the results of tests according to the test guidelines as above, it was classified in Category 2. Information in SIDS (2007) was added, and the category was changed. Besides, this substance was classified in "Xi; R38" in the EU DSD classification, and in "Skin Irrit. 2 H315" in the EU CLP classification.
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There were 2 reports of eye irritation tests (OECD TG 405) with rabbits. In one test, the primary irritation score was 3.0 (rinsed group) and slight conjunctivitis was observed up to 8 days after application, therefore, this substance was judged to be irritating (SIDS (2007)). In the other test, although the primary irritation score was 0.4 (rinsed group) and slight irritation was observed, it resolved after 72 hours (SIDS (2007)). There is a description that this substance was strongly irritating to the eyes (ACGIH (7th, 2001)). From the above, since the symptoms did not completely resolve 8 days after the application in a test according to the test guideline and there was a description of "strong irritation," it was classified in Category 2A. Besides, this substance was classified in "Xi; R36" in the EU DSD classification, and in "Eye Irrit. 2" in the EU CLP classification.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, although there is a description that this substance was a weak respiratory tract sensitizer in an inhalation exposure test with guinea pigs (SIDS (2007)), it was judged as inadequate data to be used as evidence for classification since the evaluation method was not an established one. In addition, there is a description that respiratory tract sensitization rarely occurred by exposure to this substance (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). This substance was judged as "R42" in the EU DSD classification and as "Resp. Sens. 1 H334" in the EU CLP classification.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Multiple cases of positive reactions to this substance were reported in human patch tests (SIDS (2007), ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). In addition, although there was a report that no sensitization was observed in 2 skin sensitization tests (equivalent to OECD TG 406) with guinea pigs (SIDS (2007)), in other tests such as the Buehler method, it was judged as positive for sensitization (SIDS (2007), ACGIH (7th, 2001)). From the above, since there were positive results in humans and animals, it was classified in Category 1. Besides, this substance was judged as "R43" in the EU DSD classification and as "Skin Sens. 1 H317" in the EU CLP classification.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There was no in vivo data. As for in vitro, it was positive in bacterial reverse mutation tests and a chromosomal aberration test with cultured mammalian cells (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), SIDS (2007), HSDB (Access on September 2014)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a reproduction/developmental toxicity screening test with rats by the inhalation route, at doses where parental toxicities (dead in males (1/12 animals), sacrificed in extremis in females (1/12 animals), symptoms of the respiratory organs, serous nasal discharge) were observed, decreased fertility but no developmental effects were observed (SIDS (2007), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). There is a report that in a teratogenicity test (TG 414) with female rats by the inhalation route, in the fetuses, incidences of ventricular septal defects of the heart and slight dilation of lateral brain ventricles marginally exceeded the normal range at the doses where maternal toxicities (respiratory tract irritation, decreased body weight gain) were observed (SIDS (2007), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). Although in the previous classification, it was classified as "Classification not possible" because information could not be obtained, since new information was obtained in which decreased fertility and fetotoxicities (ventricular septal defects of the heart, slight dilation of lateral brain ventricles) were observed as above at doses where parental toxicities were observed, it was classified in Category 2.
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance was irritating to the respiratory tract in humans and experimental animals (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), ACGIH (7th, 2001), SIDS (2007)). As for experimental animals, there were reports as follows: marked respiratory irritation with tremors and convulsions, and severe pulmonary congestion and edema by an inhalation exposure (0.21 mg/L, 5 hours) of rats (ACGIH (7th, 2001)); salivation, bradypnea, stridor as effects on the respiratory tract; severe diarrhea, loss of appetite and weakness by oral administration (SIDS (2007), HSDB (Access on September 2014)). As above, effects on the central nervous system and respiratory organs were observed at the doses within the guidance value range of Category 1. From the above, it was classified in Category 1 (central nervous system, respiratory organs).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	There were no adverse findings in repeated exposure in humans. As for experimental animals, although in a study in which rats were exposed by inhalation to this substance (presumed to be the vapour) for 4 weeks, at concentrations corresponding to category 1 (6-36 mg/m3: converted guidance value: 0.0018-0.011 mg/L/6 hours), symptoms of the respiratory organs (nasal discharge, labored breathing, dyspnea, stridor), increased lung weight, and tissue changes such as squamous epithelial metaplasia ranging from the nasal cavity to the bronchus, inflammatory changes in the nasal cavity and bronchiolo-alveolar area of the lungs, and thickening of the alveolar septa were observed, histopathological findings were not observed in organs other than respiratory organs, and the effects were limited to the respiratory organs (SIDS (2007), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). Similarly, also in a reproduction/developmental toxicity screening test (OECD TG 421) in which rats were exposed by inhalation to this substance, in both male and female parental animals, irritating symptoms to the respiratory organs and increased lung weight were observed within the concentration range corresponding to Category 1 (SIDS (2007), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). From the above, it was classified in Category 1 (respiratory organs). Besides, since SIDS (2007), etc. were published after the previous classification, this classification became possible.
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)	Not classified	- -	-	-	This substance is known to be stable in water and decompose slowly. It was classified as "Not classified" from 72-hour ErC50 > 5 mg/L for algae (Desmodesmus subspicatus), 48-hour EC50 > 8.3 mg/L for crustacea (Daphnia magna), and 96-hour LC50 > 8.1 mg/L for fish (Lepomis macrochirus) (all SIDS, 2007, Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012)), and because it is reported in SIDS that effets were not observed in any of the tests mentioned above including effects by degradation compounds, and the exposure concentrations for the tests were five times higher than water solubility estimates.
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 from 72-hour NOEC = 0.31 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2007, Environmental Risk Assessment for Chemical Substances Vol. 10 (Ministry of the Environment, 2012)) although it is not rapidly degradable (a 28-day degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002, SIDS, 2007)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because the substance corresponds to "Not classified" in acute toxicity for both crustacea and fish and hydrolyzes readily. By drawing a comparison between the above results, it was classified in Category 2.
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.

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