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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	111-41-1
Chemical Name	N-(2-Aminoethyl)-2-aminoethanol
Substance ID	24A6089
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th 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.
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	Not classified	- -	-	-	A flash point is 132 deg C [closed-cup] (HSDB (2002)) above 93 deg C.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 368.3 deg C (Sax (11th, 2004)).
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	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
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	- -	-	-	All of five LD50 values for rats, targets for classification (2,150, 3,914, 2,000-4,000, 3,600, 5,315 mg/kg) (SIDS (2008)) correspond to "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification or "Not classified").
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It is reported that there were no deaths after administration of 2,000 mg/kg to rats, and an LD50 value was > 2,000 mg/kg. For rabbits, it is reported that there were no deaths after administration of 2,000 mg/kg, and an LD50 value was > 2,000 mg/kg, and an LD50 value of 3,246 mg/kg is reported in another test (SIDS (2008)). From the above, it was classified as "Not classified" (one report in rabbits corresponds to "Not classified" in the Classification JIS).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available. Besides, it is reported that there were no deaths in a test with rats by 6-hour exposure to the saturated vapour, the animals tried to escape upon the start of exposure, and no findings were noted apart from strong eye irritation (SIDS (2008)).
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Category 1B	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	In a test by a semi-occlusive application of 0.5 mL of undiluted this substance to the rabbit skin, necrosis occurred in 2/2 animals after a 4-hour application and 1/4 animals after a 1-hour application, and full-thickness skin necrosis was confirmed by pathological examination (SIDS (2008)). And full-thickness skin necrosis was also observed after a 4-hour or 1-hour application in another test by an occlusive application of 0.5 mL of undiluted this substance to the rabbit skin, and it was judged as corrosive (SIDS (2008)), but only minor irritation was noted after a 3-minute application. Therefore, it was classified in Category 1B. Besides, it was classified in C: R34 in EU classification (EC-JRC (ESIS) (Access on Aug. 2012)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It is reported that in a test in which 0.05 mL of the undiluted test substance was applied to the conjunctival sac of rabbits, moderate corneal opacity as well as moderate to severe erythema and edema of the conjunctiva occurred within 1 hour after the application and persisted until day 8 at the end of an observation period, and corneal opacity was regarded as irreversible and it was judged as corrosive (SIDS (2008)). And it is reported that in another test in which 0.1 mL of the undiluted test substance was applied to the conjunctival sac of rabbits, very severe redness and swelling at one and two days after the application and very severe necrosis of the cornea after 14 days were noted, and it was judged as corrosive (SIDS (2008)). Based on the above reports, it was classified in Category 1.
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	Two patients who had used flux containing this substance as aluminum cable joiners developed severe bronchoconstriction (by respiratory function tests) at 3 hours after inhalation of the fumes of flux or this substance and this persisted for several days, and it was concluded that this substance was the substance that caused asthma following inhalation of flux vapour (SIDS (2008)). And in another report, three patients who were aluminum cable joiners developed severe delayed allergic asthma following inhalation of the fumes of flux or this substance, and the asthma was characterized by respiratory function tests (SIDS (2008)). Based on the above two reports, it was classified in Category 1.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	It was classified in Category 1 because it is reported that it was positive with a positive rate was 40% (8/20) in a maximization test with guinea pigs (SIDS (2008)), a positive result was obtained from an SI value of 3 or more in a local lymph node proliferation test with mice (LLNA) (SIDS (2008)), and this substance was listed as an allergen in Contact Dermatitis (5th, 2011). Besides, there are many case reports in which positive reactions to this substance were observed in patch tests in patients with contact dermatitis from occupational exposure (SIDS (2008)).
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow cells after oral administration to mice (OECD TG474, GLP) (in vivo somatic cell mutagenicity test) (JECDB (Access on Aug. 2012)). Besides, as for in vitro tests, Ames tests mostly gave negative results (SIDS (2008)), although there was a weakly positive result (NTP DB (1982)), chromosomal aberration tests with cultured Chinese hamster cells had a negative result in V79 cells (SIDS (2008)) but a positive result in CHL cells (JECDB (Access on Aug. 2012)), and there is a report on a negative result in an HGPRT test with Chinese hamster ovary cells (SIDS (2008)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a reproduction/developmental toxicity screening test with rats (OECD TG421, GLP), at 1,000 mg/kg/day that caused salivation and reduced weight gain, fertility decreased, the post-implantation loss was 100%, gestation index was 0%, and there were no maternal animals which delivered live pups. And an increased number of stillborn and reduced viability index were observed at 250 mg/kg/day, and necropsy of pups revealed a higher incidence of anomalies, especially effects on the pericardial vessels such as aneurysm and dilatations of the blood vessels at 50 and 250 mg/kg/day (SIDS (2008)). The cardiovascular toxicity findings were investigated in a reproduction/developmental toxicity screening test with rats, which was conducted again with partly changed test methods (OECD TG421, GLP), and it is reported that these occurred at all doses (0.2-50 mg/kg/day) without being accompanied by maternal toxicity, and increased occurrence of lesions in the blood vessels was apparent especially at 50 mg/kg/day (SIDS (2008)). Therefore, it was classified in Category 1B. Besides, cardiovascular abnormalities in fetuses were not observed in a developmental toxicity test by oral administration to rats on gestational days 6-19 (SIDS (2008)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	It is reported that dermal administration of 2,000 mg/kg to rats or rabbits caused no mortality in either animal species, and no signs of systemic toxicity were observed (SIDS (2008)), therefore it corresponds to "Not classified" in dermal administration. On the other hand, after oral administration to rats, symptoms such as dyspnea, apathy, lethargy, staggering, and prone position were found at doses above the guidance value range (SIDS (2008)), but because the details are unknown around the upper limit of the guidance value range, the classification is not possible due to lack of data. And due to no suitable data on inhalation exposure for classification, it was classified as "Classification not possible" for specific target organ toxicity (single exposure).
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney)	Warning	H373	P260 P314 P501	In a 28-day repeated oral administration test with rats (Guidelines specified by the Chemical Substances Control Law, GLP), increases in urine protein and urine specific gravity were observed in the groups at or above 250 mg/kg (converted guidance value: 77 mg/kg/day), and urinary volume decreased and kidney weights increased in the 1,000 mg/kg group (converted guidance value: 308 mg/kg/day). Histopathological examination revealed swelling and deposition of amphophilic bodies in the proximal tubules in the cortico-medullary junction in the kidney in the groups at or above 250 mg/kg, and mucosal thickening at the limiting ridge in the stomach in the groups at or above 250 mg/kg (JECDB (Access on Aug. 2012)). From the above results, because kidney effects were shown at or above 250 mg/kg (converted guidance value: 77 mg/kg/day) corresponding to the guidance values for Category 2, it was classified in Category 2 (kidney). Besides, findings in the stomach were regarded as local effects due to oral administration of a corrosive/irritating substance and were not used for classification. On the other hand, it is reported that in a 4-week repeated dermal administration toxicity test with rats (EPA guideline), only local effects were found at the skin application sites, there was no systemic toxicity, and the NOEL was 1,000 mg/kg/day (converted guidance value: 308 mg/kg/day) (SIDS (2008)), therefore it corresponds to "Not classified" in dermal administration.
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 22 mg/L for crustacea (Daphnia magna) (IUCLID, 2000).
11	Hazardous to the aquatic environment (Long-term)	Category 3	- -	H412	P273 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 3 because it is not rapidly degradable (not readily degradable, BOD 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1982)), and it was classified in Category 3 in acute toxicity.
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.

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