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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	16219-75-3
Chemical Name	5-Ethylidene-2-norbornene; Ethylidene norbornene
Substance ID	R02-B-086-MHLW, MOE
Classification year (FY)	FY2020
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 FY2009 FY2014
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)	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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 3 based on a flash point of 29 deg C (closed cup) (SIAR (2005)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties, an unsaturated bond, present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 272 deg C (SIAR (2005)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because 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). It was classified as "Not classified."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition). It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
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. It was classified as "Not classified."

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) - (5). [Evidence Data] (1) LD50 for rats: males: 2,276 mg/kg, females: 5,071 mg/kg (ACGIH (7th, 2014), SIAR (2005), Patty (6th, 2012)) (2) LD50 for rats: males: 2,294 mg/kg, females: 5,071 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)) (3) LD50 for rats: 2,527 mg/kg (HSDB (Access on May 2020)) (4) LD50 for rats: 2,530 mg/kg (GESTIS (Access on May 2020)) (5) LD50 for rats: 3,200 mg/kg (HSDB (Access on May 2020), Patty (6th, 2012))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (4). [Evidence Data] (1) LD50 for rabbits: 5,071 mg/kg (ACGIH (7th, 2014), OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)) (2) LD50 for rabbits: > 7,168 mg/kg (SIAR (2005)) (3) LD50 for rabbits: 8,190 mg/kg (GESTIS (Access on May 2020)) (4) LD50 for rabbits: 8,216 mg/kg (ACGIH (7th, 2014))
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)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] It was classified in Category 4 from (1). Besides, because an exposure concentration was lower than 90% of the saturated vapor pressure concentration (5,527 ppm), a reference value in the unit of ppm was applied as a vapor with little mist. [Evidence Data] (1) LC50 for rats (4 hours): males: 13.3 mg/L (2,717 ppm), females: 14.8 mg/L (3,015 ppm) (SIAR (2005)) (2) Vapor pressure of this substance: 4.2 mmHg (20 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 5,527 ppm) [Reference Data, etc.] (3) LC50 for rats (4 hours): 1,246 ppm (HSDB (Access on May 2020)) (4) LC50 for rats (4 hours): 6.13 mg/L (1,247 ppm) (GESTIS (Access on May 2020))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] It was classified in Category 2 from (1). The classification result was changed because new data were obtained. [Evidence Data] (1) In a skin irritation test comparable to OECD TG 404 with rabbits, mild to moderate erythema and edema were observed, and desquamation was seen in all animals from day 7, but they recovered by day 14 (SIAR (2005), Patty (6th, 2012)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] It was classified in Category 2B from (1), (2). [Evidence Data] (1) In an eye irritation test comparable to OECD TG 405 with rabbits, slight conjunctival hyperemia was found but disappeared by 2 days after application (SIAR (2005), Patty (6th, 2012)). (2) In human volunteers, transitory eye irritation was observed after exposure to this substance (11 ppm, 30 minutes) (ACGIH (7th, 2014), HSDB (Access on May 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1B from (1). The classification result was changed because new data were obtained. [Evidence Data] (1) In a mouse local lymph node assay (LLNA) according to TG 429, it was judged as positive, and EC3 was reported to be 41.7% (REACH registration dossier (Access on August 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a dominant lethal test with rats (SIAR (2005)). (2) As for in vitro, it was reported to be all negative in a bacterial reverse mutation test, a gene mutation test, a chromosomal aberration test, and a sister chromatid exchange test using cultured mammalian cells (JECDB (Access on May 2020), SIAR (2005), Patty (6th, 2012), ACGIH (7th, 2014), CEBS (Access on May 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] No data available.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 2. [Evidence Data] (1) In a reproduction toxicity screening study (OECD TG 421) with rats dosed by gavage, at a dose (100 mg/kg/day) where parental toxicity (death (2/12 males, 0/12 females), reduced body weight gain and a decrease in food consumption in males and females, and an increase in relative liver weight, and centrilobular hepatocyte hypertrophy and hepatocyte vacuolation of the liver in males) was observed, there were prolonged gestation period, and decreases in implantation and delivery indices, and decreases in total number of births, number of live births, and number of live offspring on day 4 of lactation were observed (JECDB (Access on May 2020), SIAR (2005), OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)). (2) In a developmental toxicity study by inhalation exposure of female rats on days 6 to 15 of gestation, at doses (100, 354 ppm) at which maternal toxicity (decreases in body weight and body weight gain, and a decrease in food consumption, and an increase in relative liver weight) was observed, an increase in skeletal variations was observed in fetuses (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018), SIAR (2005)). (3) The Japan Society for Occupational Health (JSOH) classified it in Group 3 of reproductive toxicant (substance which is suspected of reproductive toxicity to humans) (OEL Documentations (Japan Society For Occupational Health (JSOH), 2018)).
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on reports on human in (1) and (2), it was classified in Category 1 (central nervous system) and Category 3 (respiratory tract irritation). [Evidence Data] (1) In humans who had 30-minute of inhalation exposure to this substance (11 ppm), irritation to the eye and nose was observed (ACGIH (7th, 2014), Patty (6th, 2012)). (2) In humans, nausea and vomiting were observed in the oral route of this substance, and headache, confusion, respiratory distress, and irritation to the throat were observed in the inhalation route (Patty (6th, 2012)). [Reference Data, etc.] (3) In a single oral dose test with rats, at or above 2.0 mL/kg (1,780 mg/kg, within the range for Category 2), sluggishness, lacrimation, kyphosis, unsteady gait, and diarrhea were observed within 30 to 45 minutes of administration (SIAR (2005)). (4) In a single dermal application test with rabbits (the minimum dose at which effects were observed was not described, and it was assumed that effects were observed at a dose lower than, and not exceeding, Category 2 around the LD50 values (> 7,168 mg/kg)), almost immediate vocalization on applying the dose (persisting for about 5-15 minutes), abdominal distension, and diarrhea were observed (SIAR (2005)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 2 (liver). The changes observed in the kidney and thyroid were considered to be specific to rats (Reference Data (4)), and it was determined to have low validity for extrapolation to humans, and therefore, those organs were not considered to be target organs. [Evidence Data] (1) In a 14-week (6 hours/day, 5 days/week) test by inhalation exposure of rats to a vapor of this substance, at or above 4.9 ppm (converted guidance value: 0.02 mg/L, within the range for Category 1), an increase in kidney weight and a decrease in thyroid follicle colloid were observed in males; at or above 24.8 ppm (converted guidance value: 0.09 mg/L, within the range for Category 1), a decrease in thyroid follicle colloid, etc. were observed in females; and at 149 ppm (converted guidance value: 0.57 mg/L, within the range for Category 2), an increase in liver weight and decreases in urine osmolality and creatinine in males, and increases in kidney weight and urine protein in females were observed. The SIAR (2005) stated that changes in the kidney and thyroid were effects not extrapolable to humans (ACGIH (7th, 2014), SIAR (2005)). (2) In an 89-day test by inhalation exposure of rats to a vapor of this substance, at 90 ppm (converted guidance value: 0.44 mg/L, within the range for Category 2), kidney damage, slight enlargement and centrilobular hepatocellular degeneration of the liver, testicular atrophy, etc. were observed (ACGIH (7th, 2014), SIAR (2005)). (3) In an 89-day test by inhalation exposure of dogs to a vapor of this substance, at or above 61 ppm (converted guidance value: 0.29 mg/L, within the range for Category 2), bile duct proliferation, portal fibrosis, and increases in serum AST and ALT activity were observed; and at 93 ppm (converted guidance value: 0.46 mg/L, within the range for Category 2), testicular atrophy and slight changes in the blood were observed (ACGIH (7th, 2014), SIAR (2005)). [Reference Data, etc.] (4) In a 28-day oral toxicity test with rats dosed by gavage, from the minimum dose of 4 mg/kg/day (converted guidance value: 1.24 mg/kg/day), histopathological changes in the thyroid and kidney (hypertrophy of the thyroid follicular cells, a decrease in colloid, irregularly shaped follicles, hyaline droplets in the renal tubule epithelium) were observed in males, but the SIAR (2005) stated that changes in the kidney were related to alpha 2mu-globulin nephropathy, and changes in the thyroid were species specific, and therefore, those changes were effects not relevant to humans (JECDB (Access on May 2020), SIAR (2005)).
10	Aspiration hazard	Category 1	Danger	H304	P301+P310 P331 P405 P501	[Rationale for the Classification] It was classified in Category 1 from (1) and (2). [Evidence Data] (1) It is a cyclic hydrocarbon. (2) It is reported that aspiration causes severe pneumonia in humans (Patty (6th, 2012), HSDB (Access on May 2020)).

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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 3.3 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998), SIAR, 2002).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 because it was not rapidly degradable (a 4-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1985)) and due to 72-hour NOEC = 0.78 mg/L for algae (Raphidocelis subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 because it was not rapidly degradable (a 4-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1985)) and due to 96-hour LC50 = 7.0 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998), SIAR, 2002). From 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.
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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