GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 139-13-9
Chemical Name Nitrilotriacetic acid
Substance ID 24B6520
Classification year (FY) FY2012
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 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
-
-
- - 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 an autoignition temperature of 200 deg C (GESTIS (Access on Apr. 2012)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - No data 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.
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.

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
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)).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - No data available.
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
-
-
- - 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."
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.
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)).
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
4 Skin sensitization Classification not possible
-
-
- - No data available.
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)).
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)).
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."
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."
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)).
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
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.
11 Hazardous to the aquatic environment (Long-term) 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.
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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