NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	111-42-2
Chemical Name	2,2'-Iminodiethanol
Substance ID	m-nite-111-42-2_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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from autoignition temperatures of 280 deg C (Pocket Book of Solvent (1997)) and 662 deg C (ICSC (2002), NFPA (14th, 2010)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Not classified	- -	-	-	It was classified as "Not classified" from information that steel and aluminum are resistant as a container (Hommel (1996)). Besides, it is corrosive to copper and its compounds (Hommel (1996)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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	- -	-	-	Among 11 LD50 values for rats (2,830 mg/kg (PATTY (5th, 2001)), 3,460 mg/kg, 780 mg/kg, 1,600 mg/kg, 2,000 mg/kg, 2,370 mg/kg, 878 mg/kg, 12,760 mg/kg, 1,820 mg/kg, 2,300 mg/kg, 3,540 mg/kg (the above, SIDS (2008))), six correspond to "Not classified" in the Classification JIS, and five correspond to Category 4. It was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification or "Not classified"), to which most corresponded.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on LD50 values for rabbits of 13,000 mg/kg (SIDS (2008)) and 12.1-13.1 g/kg (ACGIH (2009)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	There is a report on an LC50 value for rats of 768 ppm/4 hours or higher (converted value: 3.30 mg/L) (ACGIH (2009)), but because it was impossible to specify the category, it was classified as "Classification not possible." Besides, because the test was conducted above the saturated vapour pressure concentration (0.37 ppm: 0.001585 mg/L), it was regarded as a test on dust.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In a test in which the test substance was applied to the rabbit skin without dilution, the skin irritation index (PII) was 2.6 (/8), corresponding to slight irritation. However, because it was assessed to be moderate irritation (SIDS (2008)), the pH of a 0.1 N aqueous solution of this substance was 11 (Merck 14th, 2006), and the EU classified it in Xi; R38, it was classified in Category 2.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In a test in which 0.1 g of the test substance was applied to the rabbit eye without dilution, strong irritation was observed at the cornea, iris, and conjunctiva, and the eye irritation index (maximum 110, equivalent to AOI) was 50-56 at 24-72 hours and 41-45 at 96-168 hours (SIDS (2008)). In addition to that, by considering that the pH of a 0.1 N aqueous solution of this substance was 11 (Merck 14th, 2006), it was classified in Category 1.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	It is reported that inhalation by male workers handling this substance caused asthmatic airway obstruction, and similar symptoms occurred after exposure to the aerosol of the cutting fluid containing 0.15% of this substance and 0.32% of triethanolamine (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)), but data are lacking for classification.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1) to (4), it was classified in Category 1A. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) The Japan Society For Occupational Health (JSOH) classified this substance in occupational skin sensitizers Group 2 (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2017)). (2) It was reported that, in a patch test on 251 workers in Germany who were suspected of dermatitis caused by cutting fluid during metal working, positive reactions were observed in 6 (3%) of the 200 workers who were tested with a 2% solution of this substance (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2021), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2017), ACGIH (8th, 2009)). (3) It was reported that, in a patch test on 144 workers in Germany who were engaged in metal working and suspected of occupational dermatitis, positive reactions were observed in 2 (2%) of the 100 workers who were tested with a 2% solution of this substance (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2021), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2017)). (4) It was reported that the patch test results collected by the Information Network of Departments of Dermatology (IVDK) showed that, in patch tests on 8,791 workers with a 2% solution of this substance conducted from 1992 to 2007, positive reactions were observed in 157 workers (1.8%) and 60 out of the 157 workers had work experience in metal working. It was also reported that, as for the positive rates in 7,112 male workers, 3,835 workers who had no work experience in the metal working industry had a positive rate of 1.0%, while 3,277 workers who had work experience in the metal working industry had a significantly high positive rate of 3.1%, and 669 workers among them, who had exposed to cutting fluids, had a significantly high positive rate of 7.5% (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2021), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2017)). [Reference Data, etc.] (5) In the DFG, it was classified in skin sensitization Sh. (6) It was reported that, in a maximization test (OECD TG 406, GLP, intradermal injection: 5% solution) using guinea pigs (n=20), the positive rate at 24 hours after challenge was 10% (2/20 animals) and the positive rate at 48 hours was 5% (1/20 animals), and this substance was negative (SIAR (2001), AICIS IMAP (2013), REACH registration dossier (Accessed Oct. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with erythrocytes after 13-week dermal administration to mice (in vivo somatic cell mutagenicity test) (SIDS (2008)). Besides, as for in vitro tests, it was reported to be negative in all of an Ames test, a chromosomal aberration test with CHO cells, and a gene mutation test with mouse lymphoma cells (NTP DB 375254 (Access on Sep. 2011)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 2 because IARC classified it in Group 2B (IARC (2011)). Besides, there was no evidence of carcinogenicity in a 103-week dermal administration test with rats, but in a 103-week dermal administration test with mice, increased incidences of liver neoplasms in males and females, and increased incidences of renal tubule neoplasms in males were observed, and it was concluded that there was clear evidence of carcinogenicity in mice (NTP TR 478 (1999)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a developmental toxicity test by oral administration to rats on gestational days 6-19, at 125 or 200 mg/kg or above where general toxicity such as reduced weight gain, decreased food consumption, and increased kidney weight was observed in maternal animals, increased postimplantation mortality and increased early postnatal mortality were reported as reproductive effects (NTP TER 96001 (1999)). Therefore, it was classified in Category 2.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (liver), Category 2 (kidney, respiratory system)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	After oral administration to rats, minimal parenchyma cell damage in the liver occurred at 200-1,600 mg/kg, large lipid droplets and focal cytoplasmic degeneration in hepatocytes at 1,600 mg/kg and renal tubule cell necrosis at or above 400 mg/kg were observed, and increases in serum concentrations of urea, SGOT, and LDH were found at 800 mg/kg (SIDS (2008)). From the above, it was classified in Category 1 (liver), Category 2 (kidney) because effects were reported within the guidance value range for Category 1 for the liver and within the guidance value range for Category 2 for the kidney. Furthermore, it is described that after 105-minute inhalation exposure of rats to 1,476 ppm (6.35 mg/L) (converted 4-hour equivalent value: 2.778 mg/L), dead animals showed lethargy, incoordination, and irregular slow respiration characterized by rales and gasping, and as characteristic findings, an initial depression of heart rate followed by a marked increase, marked respiratory distress, and increased systolic pressure were observed, and the predominant histopathological finding was pulmonary edema (SIDS (2008)). Therefore, it was classified in Category 2 (respiratory system) because the exposure concentration corresponds to the guidance values for Category 2. Besides, there is a description of central nervous system depression (ataxia, sedation) after oral administration of 200 mg/kg or higher to rats in ACGIH (2001), but it was not used for classification because it was not adopted in ACGIH (2009), and the details are unknown.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory tract), Category 2 (blood, kidney, liver)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In a 3-month inhalation exposure (mist) test with rats, squamous metaplasia in the larynx at or above 0.015 mg/L/6 hours and severe inflammation in the larynx and trachea at or above 0.15 mg/L/6 hours were seen (SIDS (2008)). It was classified in Category 1 (respiratory tract) because the doses were within the guidance value range for Category 1. Furthermore, it is reported that in a test by 49-day drinking water administration of 42-550 mg/kg/day to rats, normocytic anemia, destruction of tubular epithelial cells, distension of distal tubules with hyaline casts, and various early necrotic changes, and early degenerative changes characterized by cloudy swelling and loss of basophilia in hepatocytes were observed at or above 155 mg/kg/day (converted guidance value: 84.3 mg/kg/day) (SIDS (2008)), and in a test by 3-month drinking water administration of 25-436 mg/kg/day to rats, the occurrence of dose-dependent microcytic anemia and increases in the incidence or severity of nephropathy, renal tubular cell necrosis, or tubular mineralization were found (SIDS (2008)). Because the doses with effects correspond to the guidance values for Category 2, it was classified in Category 2 (blood, kidney, liver). Besides, in a 13-week repeated dose test by drinking water with rats, all the animals at or above 1,250 ppm (124 mg/kg/day) showed demyelination in the brain and spinal cord (NTP TOX 20 (1992)), and effects on the nervous system were suggested, but it was not used for classification due to the doses being above the guidance values for Category 2.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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	It was classified in Category 2 from 48-hour LC50 = 2.15 mg/L for crustacea (Daphnia pulex) (AQUIRE, 2012).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified in Category 3 due to being rapidly degradable (a 3-week degradation rate: by BOD: 51.4%, by TOC: 96.7%, by HPLC: 100% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), and 21-day NOEC = 0.78 mg/L for crustacea (Daphnia magna) (BUA 158, 1994). 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 being rapidly degradable (a 3-week degradation rate: by BOD: 51.4%, by TOC: 96.7%, by HPLC: 100% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1976)), and a low bioaccumulation estimate (log Kow = -1.43 (PHYSPROP Database, 2009)), despite 96-hour EC50 = 2.1-2.3 mg/L for algae (Pseudokirchneriella subcapitata) (BUA 158, 1994). By drawing a comparison between the above results, it was classified in Category 3.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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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