NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	102-81-8
Chemical Name	2-(Di-n-butylamino)ethanol
Substance ID	R01-B-013
Classification year (FY)	FY2019
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	FY2018 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 (Ver. 1.1))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	It was classified in Category 4 based on a flash point of 90 deg C (closed cup) (ICSC (2002)).
7	Flammable solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 165 deg C (ICSC (2002)).
10	Pyrophoric solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	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	*	- -	-	-	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 (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	No data available. Besides, there is information that it attacks many metals (ICSC (2002)).
17	Desensitized explosives	*	- -	-	-	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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 1,780 mg/kg (ACGIH (7th, 2001), PATTY (6th, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)) (2) LD50 for rats: 1,070 mg/kg (ACGIH (7th, 2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rabbits: 1,440 mg/kg, 1,445 mg/kg, 1,680 microL/kg (1,444.8 mg/kg) (ACGIH (7th, 2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In an inhalation exposure test (8 hours) with rats to saturated vapor (ca. 130 ppm) at room temperature (converted 4-hour equivalent value: 260 ppm): no death was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 1. [Evidence Data] (1) In an occlusive application test with rabbits for 1 minute, 5 minutes and 20 hours, necrosis was observed after 20 hours and it was judged to be corrosive (REACH registration dossier (Access on July 2019)). (2) It was reported to be corrosive in a test in which 0.01 mL was applied to rabbits for 24 hours (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). (3) This substance produced necrosis within 24 hours when applied to the skin of rabbits. In addition, when instilled in the eyes, it produced corneal necrosis (ACGIH (7th, 2001)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) In an eye irritation test in which 50 microL was administered to rabbits, the mean scores for the cornea, iris, conjunctival redness, and chemosis at 24/48/72 hours were 1.35, 0.3, 2.65, and 1.65, and it was judged to be irritating (REACH registration dossier (Access on July 2019)). (2) In an eye irritation test in which 50 microL was administered to rabbits, the mean scores for the cornea, iris, conjunctival redness, and chemosis at 24/48/72 hours were 1, 0.25, 1.25, and 0.25. It was judged to be irritating (REACH registration dossier (Access on July 2019)). [Reference Data, etc.] (3) In an eye irritation test in which 0.01 mL was administered to rabbits, it was reported to be corrosive to the cornea (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Smyth et al., (1954)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] From (1) and (2), though positive findings were observed in an in vitro chromosomal aberration test, it was negative in an in vivo micronucleus test. Therefore, based on expert judgement, it corresponds to "Classification not possible" and it was classified as "Not classified." The previous classification was changed according to the revision of the JIS. [Evidence Data] (1) As for in vivo, a negative result was reported in a mouse bone marrow micronucleus test (Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017), JECDB (Access on June 2019)). (2) As for in vitro, negative results were reported in a mammalian cell gene mutation test and bacterial reverse mutation tests (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017), JECDB (Access on June 2019), NTP DB (Access on June 2019)). There were negative and positive results reported in chromosomal aberration tests with cultured mammalian cells (Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), though no reproductive effects were observed, since no data on developmental toxicity test was obtained, it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) In a reproduction/developmental toxicity screening test with rats by the oral route, nervous system symptoms (transient salivation, restlessness, hypolocomotion, cage-licking, masticatory-like movement, tremors, clonic convulsions, tonic convulsions, vocalization) and deaths were observed in parental animals. However, no effects on fertility and the development of pups were observed (JECDB (Access on June 2019), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)). (2) In a reproductive toxicity test in which rats were exposed by inhalation for 28 days before mating in males and for 50 days from before mating to lactation Day 4 in females, though degeneration of the nasal epithelium was observed in parental animals, no reproductive effects were observed (Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system), Category 3 (respiratory tract irritation)	Warning	H371 H335	P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1) and (2), it is considered that this substance affects the nervous system by the oral route. Although there is no description of the minimum dose at which effects were observed, if the effects were observed near the LD50 value in (3), it corresponds to Category 2. Moreover, based on (4), it is considered to show respiratory tract irritation. Therefore, it was classified in Category 2 (nervous system), Category 3 (respiratory tract irritation). Besides, since the human information adopted as evidence in the previous classification is from ICSC based on the information source in List 3, and the details were unknown, it was not used. [Evidence Data] (1) There is a report that this substance produces convulsions and neuromuscular blockage resulting in respiratory arrest in rats (ACGIH (7th, 2001)). (2) There is a description that this substance is a moderate acetylcholinesterase inhibitor (ACGIH (7th, 2001)). (3) It is reported that the oral LD50 value for this substance in rats was 1,070 mg/kg or 1,780 mg/kg (ACGIH (7th, 2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). (4) There is a report that nasal irritation (rubbing the nose) was observed at or above 33 ppm in a test in which rats were exposed to the vapor of this substance by inhalation 6 hours/day for 5 days (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). Though this is a repeated exposure test, irritation to the nose may be observed from first exposure. ACGIH (7th, 2001) also cited this test result and it was considered to be the evidence for nasal irritation due to this substance.
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs), Category 2 (central nervous system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), findings indicating effects on the central nervous system such as behavioral anomalies, convulsions and tremors were observed within the range of Category 2 by oral administration to rats. Based on (3), effects on the respiratory organs were observed within the range of Category 1 in an inhalation exposure of rats. Therefore, it was classified in Category 1 (respiratory organs), Category 2 (central nervous system). As a result of adding new information and reviewing, the classification result was changed from the previous classification. [Evidence Data] (1) When rats were administered by gavage at 10-250 mg/kg/day to males for 29 days including from 14 days prior to mating up to the mating period, and females up to 3 days after delivery, restlessness, slight hypolocomotion, cage-licking, masticatory-like movement, clonic convulsion, etc. in males and females, and tremors, tonic convulsions, continuous vocalization, and death (1 animal) in females were observed at 250 mg/kg/day (converted guidance value: 81 mg/kg/day, within the range of Category 2) (JECDB (Access on June 2019), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)). (2) When rats were administered by gavage at 25-400 mg/kg/day for 28 days, an increase in the number of rearing issues was observed at or above 100 mg/kg/day (converted guidance value: 31 mg/kg/day, within the range of Category 2), and deaths (3 males, 5 females), convulsions, twitching, tremors, abnormal vocalization, pale color of the skin, gasping, hypopnea, adoption of a prone position, an increase in the number of transposition, etc. were observed at 400 mg/kg/day (converted guidance value: 122 mg/kg/day, over the range of Category 2) (JECDB (Access on June 2019), Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)). (3) When rats were administered 20.6-236.3 mg/m3 (converted guidance value: 0.006-0.02 mg/L, within the range of Category 1) by inhalation exposure for 28 days before mating in males, for 50 days up to day 4 of lactation in females, degeneration of the pharyngeal epithelium, transitional epithelium of the nasal cavity, respiratory epithelium, degeneration/regeneration of the olfactory epithelium, decreased weight of the testes and epididymis, degeneration of the laryngeal epithelium, degeneration/regeneration of the transitional epithelium, respiratory epithelium, and olfactory epithelium of the nasal cavity, decreased weight of the testes and epididymis, degeneration of the seminiferous tubules, etc. were observed. Of these, degeneration of the transitional epithelium and respiratory epithelium of the nasal cavity were considered to be toxic changes, and effects on the testes were judged to be due to stress (Environmental Risk Assessment for Chemical Substances Vol.15 (Ministry of the Environment, 2017)).
10	Aspiration hazard	*	- -	-	-	[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)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
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.
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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