NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	93-15-2
Chemical Name	4-Allyl-1,2-dimethoxybenzene
Substance ID	m-nite-93-15-2_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	Due to a flash point of 99 deg C (closed-cup, HSDB (Access on October 2016)), it corresponds to "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is an unsaturated bond (olefins) present in the molecule, but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	Due to the information that it is stable to air, heat, and light (HSDB (Access on October 2016)), it is estimated that it does not ignite in contact with air at normal temperature.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the LD50 value of 1,179 mg/kg (PATTY (6th, 2012)) for rats, this substance was classified in Category 4.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the LD50 value of > 2,025 mg/kg (PATTY (6th, 2012)) for rabbits, this substance was classified as "Not classified." The category was changed based on the new information.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	It is described that in a skin irritation test using rabbits, this substance is slightly irritating (PATTY (6th, 2012)). In addition, it is reported that this substance was not a skin irritant to rats and mice (NTP TR491 (2000)). From the above, this substance was classified as "Not classified" (Category 3 in UN GHS classification).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It is described that in an eye irritation test using rabbits, this substance is slightly irritating (PATTY (6th, 2012)). In addition, it is reported that this substance was not an eye irritant to rats and mice (NTP TR491 (2000)). From the above, this substance was classified in Category 2B.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, it is reported that when this substance at 8% was applied to 25 volunteers in a maximization test, no sensitization was seen (HSDB (Access on October 2016)), but this was judged as inadequate data for use in classification.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 data, a micronucleus test using peripheral blood of mice is negative and a DNA adduct test in the liver of mice is positive (NTP DB (Access on October 2016), IARC 101 (2013)). As for in vitro data, bacterial reverse mutation tests are negative, mammalian cell chromosomal aberration tests are negative and positive, and sister chromatid exchange tests in cultured mammalian cells are positive (NTP DB (Access on October 2016), NTP TR491 (2000), IARC 101 (2013)). However, there is a discrepancy between the descriptions of the results of the chromosomal aberration tests and sister chromatid exchange tests, so there is no validity to make a positive judgement. Positive results have been observed in the in vivo somatic cell genotoxicity tests, but there are no positive findings in the in vitro mutagenicity tests. Therefore, it was determined that the substance did not correspond to Category 2 in the GHS classification guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	In 2-year carcinogenicity studies using rats and mice administered by gavage, in rats, increases in the incidences of liver tumors (hepatocellular adenoma, hepatocellular carcinoma and hepatocholangiocarcinoma) and of neuroendocrine tumors of the glandular stomach were observed in both sexes. In addition, in males, significant increases in malignant mesothelioma, adenoma of the kidney, mammary gland fibroadenoma and subcutaneous fibroma were observed. In mice, an increase in the incidence of liver tumors (hepatocellular adenoma, hepatocellular carcinoma, hepatoblastoma and hepatocholangiocarcinoma) was observed in both sexes. The neuroendocrine tumors of the glandular stomach in males were also considered to be the effects of administration (NTP TR491 (2000)). NTP classified the carcinogenicity of this substance as R since there is clear evidence of carcinogenicity in both rats and mice (NTP RoC (13th, 2014)). Likewise, IARC, with no carcinogenicity information on humans but adequate evidence in experimental animals, classified this substance in Group 2B (IARC 101 (2013)). 　From the above, this substance corresponds to Category 2 based on the classification result by IARC. However, as a result of considering the NTP data in detail, as expert judgment, it was judged that it is appropriate to classify this substance in Category 1B for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	There is no single exposure information on humans for this substance. 　As for experimental animals, it is reported that in single dose studies using rats, mice and rabbits dosed intraperitoneally or intravenously, this substance causes temporary sleep induction and loss of righting reflexes (PATTY (6th, 2012)). These are routes other than oral, percutaneous or inhalation, but it clearly shows narcotic effects. Therefore, this substance was classified in Category 3 (narcotic effects).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (stomach, liver)	Warning	H373	P260 P314 P501	There is no information on humans. 　As for experimental animals, in a 14-week repeated dose toxicity study using rats administered by gavage, an increase in platelet count, an increase in ALT and SDH (sorbitol dehydrogenase) which indicate liver damage, an increase in liver weights, adrenal gland cortical hypertrophy and cytoplasmic alteration in the submandibular glands were observed at 100 mg/kg/day (converted guidance value: 78 mg/kg/day) or more, which is equivalent to Category 2. In a 14-week repeated dose toxicity study using mice by gavage administration, decreases in cauda epididymis and testis weights were observed at 10 mg/kg/day (converted guidance value: 7.8 mg/kg/day) equivalent to Category 1, or above; an increase in liver weights and lesions of the glandular stomach (atrophy, degeneration, necrosis, edema, mitotic alteration, and cystic glands of the fundic region of the glandular stomach) were observed at 30 mg/kg/day (converted guidance value: 23 mg/kg/day) equivalent to Category 2, or above; and lower spermatozoal concentrations were observed at 100 mg/kg/day (converted guidance value: 78 mg/kg/day) (NTP TR491 (2000)). 　In a 105-week repeated dose toxicity study using rats by gavage administration, lesions of the liver (eosinophilic focus, mixed cell focus, hepatocyte hypertrophy and oval cell hyperplasia), lesions of the glandular stomach (neuroendocrine cell hyperplasia, atrophy) and cytoplasmic alteration of the submandibular salivary gland were observed at 37 mg/kg/day, equivalent to Category 2, or more, and lesions of the liver (hepatocyte necrosis and bile duct hyperplasia) were observed at 75 mg/kg/day or above. In a 105-week repeated dose toxicity study using mice by gavage administration, lesions of the liver (eosinophilic focus, oval cell hyperplasia, hepatocyte hypertrophy, etc.) and lesions of the glandular stomach (atrophy, hyperplasia, ectasia) were observed at 37 mg/kg/day, equivalent to Category 2, or more, and lesions of the liver (hepatocyte necrosis and bile duct hyperplasia) were observed at 75 mg/kg/day or more (NTP TR491 (2000)). 　Of the above, the testis was not considered to be a target organ because it was scant in histopathological changes and they were not seen in other studies. In addition, the adrenal gland cortex hypertrophy observed in rats was not observed in long-term studies and was considered to be an adaptability finding, so it was not considered to be an effect. The cytoplasmic alteration of the submandibular salivary gland was regarded as a secondary effect because it was thought that it is an effect caused by damage to the glandular stomach. Therefore, this substance was classified in Category 2 (stomach, liver).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 3	- -	H402	P273 P501	From 96-hour LC50 = 14 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)), it was classified in Category 3.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" because it is rapidly degradable (a degradation rate by BOD: 89 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1984)), and its 21-day NOEC = 1.1 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003)). 　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 its 96-hour LC50 = 14 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2003), but it is rapidly degradable (a degradation rate by BOD: 89 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1984)), and estimated to be a low bioaccumulation (log Kow = 3.03 (PHYSPROP Database,2009)). 　It was classified as "Not classified" from the above results.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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