NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	139-13-9
Chemical Name	Nitrilotriacetic acid
Substance ID	m-nite-139-13-9_v1
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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2012	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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	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 an autoignition temperature of 200 deg C (GESTIS (Access on Apr. 2012)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2012	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).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2012	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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	It was classified in Category 4 from an LD50 value of 1,100 mg/kg for rats (Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Because 4-hour exposure to concentrations of up to 5 mg/L (dust) caused no signs of clinical abnormalities or mortalities (BUA 5 (1993)), an LC50 value exceeds 5 mg/L (corresponding to "Not classified" ). However, due to no description of animal species and unknown details, it was classified as "Classification not possible."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	It is described that this substance is irritating to the eyes, skin, and respiratory tract, inhalation causes cough and sore throat, and contact with the eye or skin produces redness (Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)), and there is data that the pH of a saturated aqueous solution of this substance was 2.3, but there is no further information or data on skin irritation. Therefore, it was classified as "Classification not possible" due to lack of data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It was classified in Category 2B because it is reported in an animal test that contact of the eye with the concentrated product or a 10% aqueous solution of this substance caused slight and reversible inflammation of the conjunctivae (BUA 5 (1993)), although animal species are unknown, and it is described that contact with the eye or skin produces redness (Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)). Besides, the pH of a saturated aqueous solution of this substance was 2.3 (HSDB (2009)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	Negative results were obtained in both a dominant lethal test by intraperitoneal administration to mice (IARC 73 (1999)) and a chromosomal aberration test with bone marrow cells after intraperitoneal administration to mice (HSDB (2009)). On the other hand, aneuploidy was seen in an in-vivo chromosomal aberration test with mouse spermatogonial cells (in vivo germ cell mutagenicity test), and it was positive (IARC 73 (1999)), which could not be regarded as sufficient evidence. There was a positive result in a micronucleus test with rat kidneys (in vivo somatic cell mutagenicity test), but it is not a standard test. And a comet test with the kidney (in vivo somatic cell genotoxicity test) was positive, but the substance is unlikely to have systemic effects, including those on germ cells, although organ-specific effects should be considered, and induction of chromosomal aberrations was considered as secondary effects. Based on the expert judgment that there was no clear evidence of in vivo somatic cell mutagenicity from the above, it was classified as "Not classified." Besides, as for in vitro tests, it is reported that an Ames test and a chromosomal aberration test with CHO cells were negative (NTP DB (Access on Apr. 2012)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	As for carcinogenicity assessment, it was classified in Group 2B by IARC (IARC 73 (1999)), Group 2B by Japan Society for Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits Vol. 53 (Japan Society For Occupational Health (JSOH), 2011)), and R by NTP (NTP RoC 12th (2011)). Therefore, it was classified in Category 2. Besides, in tests with rats and mice given 18-month diet administration followed by observation for six months for rats and three months for mice, in the highest dose group (15000 ppm) in both animal species, incidences of urinary-tract neoplasms were significantly increased, the occurrence of which was not found in the control group or rarely develop spontaneously in animals of the strain, and this substance was shown to be carcinogenic to the urinary tract of rats and mice (NTP TR 6 (1977)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In a test with mice dosed by drinking water at a 2% concentration of this substance on gestational days 6-18, accumulation of the substance in the bone was observed, but there were no skeletal or visceral malformations (Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)), and no adverse effects in maternal animals, embryos, or fetuses were reported after oral administration to pregnant rabbits and rats (IARC 73 (1999)). And in a test in which the trisodium salt monohydrate of this substance was given to pregnant rats by drinking water during the organogenesis period, hydronephrosis and urinary-bladder defect were seen in fetuses, which were regarded as variations, and no other anomalies were observed in the number of embryos/fetuses or fetal skeletal system (IARC 48 (1990), the source: TOXICOLOGY AND APPLIED PHARMACOLOGY (1972)). However, because effects on sexual function and fertility are unknown due to no data, it was classified as "Classification not possible."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	It is described that following a single oral dose to rats, histologically detectable lesions of the kidney can occur, which are quickly reversible at low doses, and lasting damage is only to be expected after chronic exposure (BUA 5 (1993)). And it is reported that 4-hour exposure to concentrations of up to 5 mg/L (dust) caused no signs of clinical abnormalities or mortalities (BUA 5 (1993)), although animal species is unknown. In either of the above, there are no concrete supporting data, and the details are unknown. Therefore, it was classified as "Classification not possible."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney)	Warning	H373	P260 P314 P501	It is described that long-term or repeated exposure to this substance could produce effects on the kidney (Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)). It is described that the main toxicological effects of this substance are damage to the kidney and urinary tract, it disturbs the electrolytic metabolism of the cells and is directly excreted via the kidney, the highest concentrations are found in the kidney and urinary tract, and the surrounding cells (renal tubule cells, transitional epithelium cells of the urinary tract) constitute the target tissues most strongly affected (BUA 5 (1993)). Based on the description in the assessment document in List 2 (BUA), it was classified in Category 2 (kidney). Besides, as for animal tests, in 18-month diet administration tests with rats and mice, non-neoplastic lesions of the urinary tract characterized by nephritis and/or hydronephrosis were reported at high doses exceeding the guidance value range (NTP TR 6 (1977)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	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 3	- -	H402	P273 P501	72-hour ErC50 was > 30 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)). An expert judged that 72-hour ErC50 was apparently between 30-100 mg/L because of growth inhibition rate of 44.7% (growth rate method, pH within normal range) at 30 mg/L in the final report of the test. Therefore, it was classified in Category 3.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (not readily degradable (a 4-week degradation rate by BOD: 1%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2003)), and 72-hour NOEC = 0.3 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances Vol. 2 (Ministry of the Environment, 2003)). 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 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (Environmental Risk Assessment for Chemical Substances Vol. 2 (Ministry of the Environment, 2003)). By drawing a comparison between the above results, it was classified in Category 2.	FY2012	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.	FY2012	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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