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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	123-35-3
Chemical Name	7-Methyl-3-methylene-1,6-octadiene
Substance ID	R02-B-032-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	FY2010
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 39 deg C (closed cup) (GESTIS (Access on April 2020)).
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	Classification not possible	- -	-	-	No data available.
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), (2). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (JECFA FAS54 (2006)) (2) LD50 for rats: > 5,000 mg/kg (It is described that there were no deaths up to the highest dose of 11,390 mg/kg) (REACH registration dossier (Access on June 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: > 5,000 mg/kg (REACH registration dossier (Access on June 2020))
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)	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) - (3). [Evidence Data] (1) This substance is an irritant in humans, and exposure to this substance induces dermatitis and conjunctivitis (NTP TR557 (2010)). (2) This substance is a moderate skin and eye irritant (HSDB (Access on May 2020)). (3) In an in-vitro skin irritation test using the human epidermis model (EPISKIN) according to ECVAM protocol version 1.8 (2009), it was judged as an irritant (REACH registration dossier (Access on June 2020)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] It was classified in Category 2A from (1) - (3). The classification result was changed due to new data (1) obtained. [Evidence Data] (1) In an eye irritation test with rabbits (3 animals) according to OECD TG 405, the mean score at 24/48/72 hours after application was 2 or more in 1 animal for conjunctival redness and 2 animals for chemosis, and all the reactions disappeared after 8 days (REACH registration dossier (Access on June 2020)). (2) This substance is an irritant in humans, and exposure to this substance induces dermatitis and conjunctivitis (NTP TR557 (2010)). (3) This substance is a moderate skin and eye irritant (HSDB (Access on May 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] There is a description of (1), but it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) It is reported that a man employed as a brewery inspector developed a respiratory hypersensitivity reaction to this substance, a component of hops (HSDB (Access on May 2020)).
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). The classification result was changed due to new data obtained. [Evidence Data] (1) In a mouse local lymph node assay (LLNA) according to TG429, the SI value did not exceed 3, and it was judged as negative (REACH registration dossier (Access on June 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 is reported that it was negative in a chromosomal aberration test with bone marrow cells after single oral administration to rats (IARC 119 (2019), JECFA FAS54 (2006)) and negative in a micronucleus test with peripheral blood erythrocytes after 13-week oral administration to mice (IARC 119 (2019), NTP TR557 (2010), JECFA FAS54 (2006), HSDB (Access on May 2020), CEBS (Access on May 2020)). (2) As for in vitro, it is reported that it was negative in a bacterial reverse mutation test (IARC 119 (2019), NTP TR557 (2010), JECFA FAS54 (2006), HSDB (Access on May 2020), CEBS (Access on May 2020)) and all negative in a chromosomal aberration test and a sister chromatid exchange test with human lymphocytes, a gene mutation test and a sister chromatid exchange test with Chinese hamster V79 cells, and a sister chromatid exchange test with rat liver tumor cells (IARC 119 (2019), JECFA FAS54 (2006)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1), (2). [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 2B by IARC (IARC 119 (2019)) and Group 2B by the Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), proposed in 2018)). (2) In carcinogenicity tests by 2-year gavage administration of this substance to male and female rats and mice, a significant increase in the incidence of renal tubule neoplasms (adenoma or carcinoma) in male rats and significant increases in the incidences of hepatocellular adenoma, hepatocellular carcinoma, and hepatoblastoma in male mice were observed. A slight increase in the incidence of renal tubule neoplasms in female rats and a slight increase in the incidence of hepatocellular neoplasms in female mice were found. From the above, it was concluded that there was clear evidence of carcinogenicity of this substance in male rats and mice, and there was equivocal evidence in female rats and mice (NTP TR557 (2010)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 1B. After reviewing the data, since the appearance of the skeletal malformations was emphasized, and in the test in (3), reproductive and developmental effects were observed at doses at which no maternal toxicity was observed unlike the previous classification, the classification results were changed from the previous classification. [Evidence Data] (1) In a one-generation reproduction toxicity study with rats dosed by gavage, at a dose of toxicity in parent animals (increases in liver and kidney weight, etc.), an increase in the number of resorptions and a parallel decrease in the number of live fetuses, and an increase in the number of fetuses with skeletal malformations were observed (JECFA FAS54 (2006)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6-15 of gestation, at a dose at which maternal toxicity (reduced body weight gain, death (one animal)) was observed, reduced numbers of visible implantation sites and live fetuses, and increased incidences of fetuses with delayed ossification and skeletal malformations were observed (JECFA FAS54 (2006)). (3) In an oral toxicity test with female rats dosed by gavage from day 15 of gestation to postnatal day 21 during the perinatal and lactation period, at a lower dose than the one at which general toxicity (a decrease in body weight, keratosis of the forestomach) was observed in dams, increases in the duration of labor and the number of stillbirths, a decrease in birth weight of offspring, an increase in the postnatal mortality (especially in week 1 of lactation), and delayed developmental indexes were observed (JECFA FAS54 (2006)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in the oral route and dermal route. However, classification was not possible since there was no information available for classification in the inhalation route. [Evidence Data] (1) In an acute oral toxicity test with rats dosed by gavage (dose: 670-11,390 mg/kg), no death was observed, and in general, only piloerection was observed at 1,000-11,390 mg/kg, and no abnormalities were observed in necropsy (REACH registration dossier (Access on June 2020)). (2) In an acute dermal toxicity test with rabbits (dose: 5,000 mg/kg), no deaths or systemic effects were observed, slight to moderate transient erythema and edema were observed, and no abnormalities were observed in necropsy (REACH registration dossier (Access on June 2020)). [Reference Data, etc.] (3) It was reported that ED50 for the analgesic effect in mice dosed in the oral route was 16 mg/kg, and the mice treated with this substance exhibited an increase in antinociceptive activity (analgesic effect) in a hot plate test (NTP TR557 (2010)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data. There were data of (1) to (4), and all tests were carried out at doses exceeding Category 2, and in (1) and (2), effects were observed up to the minimum dose level exceeding Category 2, but since effects in the upper limit of the guidance value range were unknown, it was considered that classification was not possible. [Reference Data, etc.] (1) In a 14-week oral toxicity test with rats dosed by gavage (dose range: 250-4,000 mg/kg/day), at or above 250 mg/kg/day (converted guidance value: 194 mg/kg/day, exceeding Category 2), which was the minimum dose level, necrosis of the renal tubules in males and females, and hyaline droplet accumulation of the renal tubules in males were observed; at or above 500 mg/kg/day (converted guidance value: 389 mg/kg/day, exceeding Category 2), death, a decrease in body weight, and increased porphyrin pigmentation in the Harderian gland in males were observed; at or above 1,000 mg/kg/day (converted guidance value: 778 mg/kg/day, exceeding Category 2), increased chronic inflammation of the nose, and nephrosis in males and females, and atrophy of the mesenteric lymph node in females were observed; at 2,000 mg/kg/day (converted guidance value: 1,556 mg/kg/day, exceeding Category 2), degeneration of the olfactory epithelium, and atrophy of the spleen in males and females, atrophy of the mesenteric lymph node in males, death, and acute inflammation of the forestomach in females were observed; and at 4,000 mg/kg/day (converted guidance value: 3,111 mg/kg/day, exceeding Category 2), deaths were observed in all males and females (NTP TR557 (2010)). (2) In a 105-week oral toxicity test with rats dosed by gavage (dose range: 250-1,000 mg/kg/day), at or above 250 mg/kg/day (exceeding Category 2), which was the minimum dose level, hyperplasia of the transitional epithelium of the renal pelvis, and focal suppurative inflammation of the kidney in males and females, renal tubule nephrosis, and mineralization the renal papilla in males, and increased nephropathy in females were observed; at or above 500 mg/kg/day (exceeding Category 2), increased severity of nephropathy in males and females, chronic active inflammation of the nose, and chronic active inflammation of the forestomach in males, and renal tubule nephrosis in females were observed; and at 1,000 mg/kg/day (exceeding Category 2), deaths were observed in all males (NTP TR557 (2010)). (3) In a 14-week oral toxicity test with mice dosed by gavage (dose range: 250-4,000 mg/kg/day), at or above 500 mg/kg/day (converted guidance value: 389 mg/kg/day, exceeding Category 2), an increase in liver weight was observed in females; at 1,000 mg/kg/day (converted guidance value: 778 mg/kg/day, exceeding Category 2), a decrease in body weight in males and an increase in kidney weight in females were observed; at 2,000 mg/kg/day (converted guidance value: 1,556 mg/kg/day, exceeding Category 2), deaths (9/10 males, 8/10 females) were observed; and at 4,000 mg/kg/day (converted guidance value: 3,111 mg/kg/day, exceeding Category 2), deaths were observed in all males and females (NTP TR557 (2010)). (4) In a 105-week oral toxicity test with mice dosed by gavage (dose range: 250-1,000 mg/kg/day), at 500 mg/kg/day (exceeding Category 2), hepatocyte hypertrophy in males and females, and a decrease in body weight, bone marrow atrophy, lymphoid follicle atrophy in the spleen, and inflammation and epithelial hyperplasia in the forestomach in females were observed; and at 1,000 mg/kg/day (exceeding Category 2), a decrease in survival rate in males and females, and a decrease in body weight in males were observed (NTP TR557 (2010)).
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)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour EC50 = 0.45 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 3 because it was rapidly degradable (a 2-week degradation rate by BOD: 86% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1987)) and due to 21-day NOEC = 0.12 mg/L for crustacea (Daphnia magna) (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 1 due to a high bioaccumulation estimate (log Kow = 4.17 (PHYSPROP, 2020)) and 96-hour LC50 = 0.92 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998)), although it was rapidly degradable (a 2-week degradation rate by BOD: 86% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1987)). By drawing a comparison between the above results, it was classified in Category 1.
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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