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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	16219-75-3
Chemical Name	Ethylidene norbornene
Substance ID	H26-B-013, -
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	FY2009 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. Because this substance is not 1,2-dien compounds, the category was changed.
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	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) (SIDS (2005)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group (unsaturated bond) associated with self-reactive properties present in the molecule, but 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 272 deg C (SIDS (2005)).
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	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine
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	- -	-	-	There are 4 reports of LD50 values of 2,536 mg/kg (ACGIH (7th, 2001)), 2,276 mg/kg (male), 5,071 mg/kg (female) (PATTY (6th, 2012), SIDS (2005)) and 3,200 mg/kg (PATTY (6th, 2012)) for rats. Since one value corresponded to "Not classified" and 3 values to "Not classified" (Category 5 in UN GHS classification), it was classified as "Not classified" (Category 5 in UN GHS classification), the category to which the largest number corresponded.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on reports of LD50 values of >7,168 mg/kg (SIDS (2005), PATTY (6th, 2012)) and 8,216 mg/kg (ACGIH (7th, 2001)) for rabbits, it was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Based on reports of LC50 values (4 hours) of 13.3 mg/L (=2,717 ppm) (male) and 14.8 mg/L (=3,015 ppm) (female) (SIDS (2005)) for rats, it was classified in Category 4. Besides, since there is a description that this test was conducted under saturated vapour and the LC50 values were lower than 90% of the saturated vapor concentration (5,528 ppm), the reference value in units of ppm was applied as a vapour without a mist.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	In a skin irritation test with rabbits, slight to moderate erythema and edema were observed and reversibility was shown. Average scores of 2.3 or more for erythema or edema were confirmed in less than 4 out of 6 animals (SIDS (2005)). From the above results, it was classified as "Not classified" (Category 3 in UN GHS classification).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Since there is a report that in an eye irritation test with rabbits, slight irritation was observed, and slight conjunctival hyperemia occurred but resolved by 7 days (SIDS (2005)), it was classified in Category 2B.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, there is a negative report in a dominant lethal test with rats (SIDS (2005)). As for in vitro, it was all negative in bacterial reverse mutation tests and a gene mutation test, a chromosomal aberration test and a sister chromatid exchange test with cultured mammalian cells (JECDB (Access on June 2014), SIDS (2005), PATTY (6th, 2012), NTP DB (Access on July 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 (OECD TG421) with rats by the oral route (gavage), there were prolongation of the gestation period and decreases in the number of implantation and delivery indices, and decreases in total number of births, number of live offspring, and number of live offspring on Day 4 of lactation were observed at the dose (100 mg/kg bw/day) where parental toxicity (death in 2 males, suppressed body weight gain and decreased food consumption in both sexes, increased relative liver weight, and centrilobular hypertrophy and vacuolation of hepatocytes in the liver in males) was observed (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Committee) (2005), SIDS (2005)). Besides, as for teratogenicity, in a teratogenicity test with rats by the inhalation route, no teratogenicity was observed (minimal fetotoxicity: skeletal variants only) at doses where (at or above 100 ppm) maternal toxicities (transient decreases in body weights, body weight gain and food consumption, increased relative liver weights) were observed (SIDS (2005)). Therefore, it was classified in Category 2.
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	In humans, there is a report that it was irritating to the nose and throat after 30 minutes at 11 ppm by the inhalation route (ACGIH (7th, 2001), PATTY (6th, 2012)), and there are reports of headache, confusion, and respiratory distress by the inhalation route, of severe pneumonia by aspiration, and of vomiting if swallowed by the oral route (PATTY (6th, 2012)). In rats, deaths were observed by an inhalation exposure to 3,431 ppm, and the symptoms were hindlimb paralysis, urogenital area wetness, hypothermia, absent surface righting and toe and tail pinch reflexes, in addition, central nervous symptoms such as hyperreactivity, tremors and convulsions. By an inhalation exposure of dogs, poor coordination at 3,232 ppm (7 minutes), tonic convulsions at 2,186 ppm (30 minutes) and 3,232 ppm (15 minutes), and deaths at 3,232 ppm (1.5 hours) were reported. By an oral administration to rats, sluggishness, lacrimation, kyphosis, unsteady gait, diarrhea, piloerection and tremors were observed at or above 2.0 mL/kg. In addition, by the dermal route, persisting immediate vocalization for 5-15 minutes, emaciation, abdominal distension and diarrhea were reported during application to rabbits (SIDS (2005), HSDB (Access on June 2014)). Moreover, also in PATTY, there is a report that by inhalation exposure with rats, mice and rabbits, it causes tremors, ataxia and convulsions (PATTY (6th, 2012)). These effects in experimental animals were observed within the guidance value range corresponding to Category 2. From the above, in experimental animals, although the effects on the central nervous system were observed within the guidance value range corresponding to Category 2, the effects were also observed in human cases, therefore, it was classified in Category 1 (central nervous system), in addition, Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	In tests in which rats and dogs were exposed by inhalation to the vapour of this substance for 88 days and 89 days respectively, enlarged liver and degeneration of the central cord cells of the liver in rats, and bile duct proliferation, fibrosis in the portal region, and increased serum AST and ALT activities in dogs were observed as effects on the liver at 90 ppm (converted guidance value: 0.44 mg/L) in rats and at 61 ppm (converted guidance value: 0.29 mg/L) in dogs (ACGIH (7th, 2001), SIDS (2005), PATTY (6th, 2012)), which were concentrations equivalent to Category 2. On the other hand, in a test in which rats were dosed by gavage for 28 days, although histopathological changes in the thyroid and the kidneys (hypertrophy of follicular cells, decreased colloid, and irregular follicular shape in the thyroid: hyaline droplets in the renal tubule epithelium) were observed in males from the lowest dose of 4 mg/kg/day (converted guidance value: 1.24 mg/kg/day) (JECDB (Access on June 2014), PATTY (6th, 2012)), it was concluded in SIDS (2005) that the changes in the kidneys were ones related to alpha 2u-globulin nephropathy, and that the changes in the thyroid were also a species-specific change, neither of which occurred in humans. Therefore, also in this classification, this opinion was supported, and the thyroid and kidneys were not adopted as target organs. Besides, similar effects on the thyroid and kidneys were observed in a 14-week inhalation exposure test with rats (SIDS (2005), PATTY (6th, 2012)). From the above, it was classified in Category 2 (liver).
10	Aspiration hazard	Category 1	Danger	H304	P301+P310 P331 P405 P501	On the basis that it is a hydrocarbon and that there is a description that it caused severe pneumonia by inhalation in humans (PATTY (6th, 2012), HSDB (Access on June 2014)), it was classified in Category 1.

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)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
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.

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