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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	111-42-2
Chemical Name	2,2'-Iminodiethanol
Substance ID	23B5514
Classification year (FY)	FY2011
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	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards & 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	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available.
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 applicable	- -	-	-	Solid (GHS definition)
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)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) 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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
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)).

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
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.
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)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
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.
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.
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.
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.
4	Skin sensitization	Not classified	- -	-	-	In a guinea pig maximization test (OECD TG 406, GLP), no skin sensitizing potential was noted with a positive rate of 10% (2/20), and it was concluded that this substance is not a skin sensitizer in animals (SIDS (2008)). Therefore, it was classified as "Not classified." Besides, as for humans, in patch tests on components of metalworking fluid in patients with dermatitis from occupational exposure, a slightly higher incidence of positive rates was seen (SIDS (2008)), but it is reported that no sensitization was observed in a repeated insult patch test in healthy subjects (SIDS (2008)). Also, this substance is listed as a contact allergen in Contact Dermatitis (Frosch) (4th, 2006), but data in the test with guinea pigs above were adopted as the rationale.
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)).
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)).
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.
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.
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.
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 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour LC50 = 2.15 mg/L for crustacea (Daphnia pulex) (AQUIRE, 2012).
11	Hazardous to the aquatic environment (Long-term)	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.
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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