NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	97-88-1
Chemical Name	n-Butyl methacrylate
Substance ID	m-nite-97-88-1_v2
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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Based on a flash point of 50 deg C (closed cup) (ICSC (2009)), it was classified in Category 3.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (olefins) present in the molecule, but the classification is not possible due to no data. Besides, stabilized one is classified in class 3 (UN 2227) in UNRTDG, and does not correspond to hazard class with the highest precedence, self-reactive substances and mixtures, and is classified in Class G.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 290 deg C (ICSC (2009)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	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.	FY2015	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).	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2015	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	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2015	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)	Not classified	- -	-	-	Based on reports of LD50 values for rats of > 2,000 mg/kg (OECD TG 401) (SIDS (2009), ECETOC JACC (1997)), > 3,200 mg/kg (ECETOC JACC (1997)), 16,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012), ECETOC JACC (1997)), 17,900 mg/kg (SIDS (2009), ECETOC JACC (1997)), 18,020 mg/kg, 18,561 mg/kg (ECETOC JACC (1997)), 22,600 mg/kg (PATTY (6th, 2012)), 16,000-22,600 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), this substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the reports of LD50 values for rabbits of > 2,000 mg/kg (OECD TG 402) (SIDS (2009), ECETOC JACC (1997)), 10,181 mg/kg (ECETOC JACC (1997)), 11.3 mL/kg (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)), 11,300 mg/kg (PATTY (6th, 2012)), 10,181-11,300 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), this substance was classified as "Not classified."	FY2015	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)	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	There is a report that a result of a 4-hour inhalation test (OECD TG 403) with rats was 29 mg/L as approximate lethal concentration (ALC value) (SIDS (2009)). In addition, it was reported that the LC50 values for rats were 19.7 mg/L (ECETOC JACC (1997)), 28.6 mg/L (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012), SIDS (2009)). Therefore, this substance was classified as "Not classified." Besides, since the LC50 values were higher than 90% of the saturated vapor pressure concentration (17.2 mg/L), a reference value in the unit of mg/L was applied as vapour mixed with mist.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a report that in a skin irritation test (OECD TG404) with rabbits, as a result of a semi-occlusive application with 0.5 mL of this substance for 4 hours, no irritation was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) or the irritation was mild (SIDS (2009)). There are other multiple reports that in skin irritation tests with rabbits, as a result of a semi-occlusive application with this substance for 4 hours, the irritation observed was mild (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2009), ECETOC JACC (1997)). From the above, this substance was classified as "Not Classified" (Category 3 in UN GHS classification). Based on the report of the guideline-compliant test, the category was changed. Besides, this substance was classified as "Skin. Irrit. 2 H315" in the EU CLP classification (ECHA CL Inventory (Access on December 2015)). Since it was not possible to confirm the data based on the guidelines from 1981 onward described in the previous classification, it was not used for classification.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	There are two reports that in eye irritation tests (OECD TG405) with rabbits, no irritation of the eyes by applying this substance was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2009)). There are other reports that slightly irritating and highly irritating were observed in eye irritation tests with rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2009), ECETOC JACC (1997)), however, the details of the test methods, etc. are unknown. From the above, this substance was classified as "Not classified" based on the guideline-compliant test. Besides, this substance was classified as "Eye. Irrit. 2 H319" in the EU CLP classification (ECHA CL Inventory (Access on December 2015)).	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1B. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in a Local Lymph Node Assay (LLNA) (OECD TG 429, GLP) with mice (n=5/group), the Stimulation Index (SI values) were 2.19 (25%), 3.28 (50%), and 5.14 (100%), and the EC3 value was calculated to be 43.6% (REACH registration dossier (Accessed Jan. 2022)). [Reference Data, etc.] (2) It was reported that 243 contact dermatitis patients who had been exposed to acrylate or methacrylate ester were given patch tests with this substance at a concentration of 2% and positive reactions were observed in 6 patients (2.5%) (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), REACH registration dossier (Accessed Jan. 2022)). (3) 542 dermatitis patients were given patch tests with this substance at a concentration of 1% and one individual showed positive reactions. But this patient had used acrylic paint in the past and the reaction was considered to be associated with it (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2013), REACH registration dossier (Accessed Jan. 2022)). (4) Humans exposed to acrylates were given patch tests with this substance and a very few cases showed positive reactions and confirmed the weak skin sensitization potential of this substance (AICIS IMAP (2014), SIAP (2004), Canada CMP Screening Assessment (2018)). (5) 347 patients suspected to have contact dermatitis were given patch tests and one patient (0.3%) showed positive reactions to this substance at a concentration of 2% (REACH registration dossier (Accessed Jan. 2022)). (6) It was reported that 331 people who had been exposed to (meth)acrylates were given patch tests at a concentration of 2% and 2 people (0.6%) showed positive reactions (REACH registration dossier (Accessed Jan. 2022)). (7) It was reported that, in a Maximization test (OECD TG 406, GLP, intradermal induction: 5% solution) with guinea pigs (n=5), the positive rates in 24 and 48 hours after challenge were 80% (4/5 animals) and 40% (2/50 animals), respectively (REACH registration dossier (Accessed Jan. 2022)). (8) In the DFG, it was classified in Sh (List of MAK and BAT values (2020)). (9) In the ECHA, it was classified in Skin Sens. 1 (EU-CLP Classification Results (Accessed Jan. 2022)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	This substance was classified as "Classification not possible" since it is not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, a micronucleus test with mouse bone marrow cells was negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), JECDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), SIDS (2009)). As for in vitro, bacterial reverse mutation tests and mammalian cell chromosome aberration tests were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), JECDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), SIDS (2009)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats by the oral route, at 1,000 mg/kg/day where general toxicity (a decrease in weight gain, a decrease in food consumption, atrophy of the red pulp of the spleen, etc.) in parental animals was manifested, decreases in the numbers of corpora lutea and implantations (Implantation rate was unchanged) were observed in maternal animals, but no effects on the paternal fertility and offspring were observed (SIDS (2009), JECDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). In addition, it is reported that in a developmental toxicity test with pregnant female rats exposed to this substance by inhalation on Gestational Days 6-20, decreased weight gain at or above 300 ppm and decreased food consumption at 1,200 ppm were observed in maternal animals, and in fetuses, low values of body weight were observed in females of 600 ppm or above and males of 1,200 ppm, respectively, but no teratogenicity was observed (SIDS (2009), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). As above, in the preexisting findings of experimental animals, there is no evidence of clear developmental toxicity that should be adopted as evidence for the classification, and in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by the oral route, decreases in the number of corpus luteum and implantations were observed in females when the limit dose was administered. It was described that there was no abnormality in ovarian follicle formation from the results of histopathological examination and these findings were speculated to be some effect related to ovulation, but no effects on the delivery index, pregnancy period, or nursing condition were observed in maternal animals (JECDB (Access on November 2015)). Based on the description, it was judged that these findings were not at least those which should be adopted as evidence for the classification for reproductive effects. Because there is no available data for the classification other than this, it was classified as "classification not possible" for this hazard class due to lack of data. In the reclassification, the category was changed by revision of the GHS classification guidance for the Japanese Government or re-examination of the information sources.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	This substance is irritating to the respiratory tract (ECETOC JACC (1997), HSDB (Access on November 2015), Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), PATTY (6th, 2012)). In humans, cough, shortness of breath, sore throat from inhalation exposure, and abdominal pain by oral ingestion were seen (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013)). As for experimental animals, there was no finding that can be used for classification. From the above, this substance was classified in Category 3 (respiratory tract irritation).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (spleen)	Warning	H373	P260 P314 P501	There is no data on humans. As for experimental animals, in a 14-day repeated oral dose test with rats, a decrease in the hematocrit value was observed in males at 500 mg/kg/day (converted guidance value: 77.8 mg/kg/day) within the range of Category 2, and in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats by gavage, a decrease in the absolute and relative spleen weight and atrophy of the red pulp due to decreased extramedullary hematopoiesis were observed in males at 100 mg/kg/day (converted guidance value: 48.9 mg/kg/day) within the range of Category 2 (Environmental Risk Assessment for Chemical Substances Vol.11 (Ministry of the Environment, 2013), JECDB (Access on November 2015)). In a 4-week inhalation toxicity test with rats, no effect was observed at doses within the range of Category 2 (Environmental Risk Assessment for Chemical Vol.11 (Ministry of the Environment, 2013)). As in the above, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, effects on the spleen were observed within the range of Category 2. Besides, since the findings observed in the 14-day test were not toxic enough to meet the classification criteria, they were not adopted as evidence for the classification. Therefore, this substance was classified in Category 2 (spleen).	FY2015	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. Besides, the kinematic viscosity is calculated to be 3.486 mm2/sec (21/20 deg C) from the numerical data (Viscosity: 3.116 mPa*s (21 deg C), density: 0.8936 g/cm3 (20 deg C)) listed on HSDB (Access on November 2015).	FY2015	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 2	- -	H401	P273 P501	From 96-hour LC50 = 5.57 mg/L for fish (Oryzias latipes) (Initial Risk Assessment (NITE, CERI, NEDO, 2008), SIDS, 2009, Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013)), it was classified in Category 2.	FY2015	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" due to being rapidly degradable (a degradation rate by 28-day BOD = 88%, a degradation rate by GC = 100% (Official Bulletin of Ministry of International Trade and Industry, 1997)), and 21-day NOEC (reproduction) = 1.1 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008), SIDS, 2009). 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" due to rapid degradability and a low bioaccumulation estimate (log Kow = 2.88 (PHYSPROP Database, 2009)) although 96-hour LC50 = 5.57 mg/L for fish (Oryzias latipes) (Initial Risk Assessment (NITE, CERI, NEDO, 2008), SIDS, 2009, Environmental Risk Assessment for Chemical Substances vol. 11 (Ministry of the Environment, 2013)). From the above, it was classified as "Not classified."	FY2015	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.	FY2015	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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