GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 1071-83-6
Chemical Name N-(phosphonomethyl)glycine [glyphosate]
Substance ID H28-B-016, C-023B
Classification year (FY) FY2016
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 FY2008  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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
-
-
- -  There is the information of being combustible (GESTIS (Access on May 2016)), but the classification is not possible due to no data.
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 Classification not possible
-
-
- -  No data available.
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 classified
-
-
- -  It is estimated that it does not react vigorously with water due to water solubility measured (10.1 g/L (20 deg C)) (GESTIS (Access on May 2016)).
13 Oxidizing liquids Not applicable
-
-
- -  Solid (GHS definition).
14 Oxidizing solids Classification not possible
-
-
- -  The substance is an organic compound containing oxygen which is chemically bonded to the element other than carbon or hydrogen, but the classification is not possible due to no data.
15 Organic peroxides Not applicable
-
-
- -  Organic compounds containing no bivalent -O-O- structure in the molecule
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) Not classified
-
-
- -  Based on the LD50 values of 2,047 mg/kg (EHC 159 (1994)), > 4,320 mg/kg (EPA RED (1993)), > 5,000 mg/kg (EHC 159 (1994), JMPR (2004), Food Sanitation Research (2000)), 5,600 mg/kg, 10,537 mg/kg, 11,343 mg/kg (Japanese Journal of Pesticide Science (Pesticide Science Society of Japan, 2000)), and 4,900 - 6,300 mg/kg (JMPR (2004)) for rats, this substance was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified
-
-
- -  Based on the LD50 value of > 2,000 mg/kg (EHC 159 (1994), JMPR (2004), EPA RED (1993)) for rats and an LD50 value of > 5,000 mg/kg (EHC 159 (1994), JMPR (2004), Japanese Journal of Pesticide Science (Pesticide Science Society of Japan, 2000)) for rabbits, this substance was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- -  Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- -  Classification not possible due to lack of data.
 Besides, there are reports of LC50 values of > 4.43 mg/L (JMPR (2004)) and > 4.98 mg/L (JMPR (2004), HSDB (Access on May 2016)) for rats. However, these were not adopted as data because it cannot be determined whether they correspond to Category 4 or "Not classified."
2 Skin corrosion/irritation Not classified
-
-
- -  It is reported that in a test using rabbits (US EPA guidelines or OECD TG 404, GLP), slight irritation was observed and the score is 0.8. It is reported that in 4 other tests using rabbits (US EPA guidelines or OECD TG 404, GLP), no irritation was observed in any of these tests (EHC 159 (1994), JMPR (2004)).
 Therefore, this substance was classified as "Not classified."
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310 		 In three studies using rabbits (US EPA guidelines or OECD TG 405, GLP), symptoms not resolving during the observation period of 21 days were observed. In the first test, corneal opacity and conjunctival blistering (six out of six), pannus of the cornea (three out of six), vascularization of the conjunctiva (one out of six) and blood like discharge (one out of six) were observed, and these persisted during the 21 days in three out of five animals (JMPR (2004)). Also in the second test, conjunctival opacity, conjunctival redness and conjunctival edema were observed in all animals, and they persisted during the 21 days in two out of six animals (JMPR (2004)). Also in the third test, symptoms in the cornea, iris and conjunctiva were observed. Among these, slight cornea responses persisted through the 21 days (JMPR (2004)).
 From the above, this substance was classified in Category 1.
 Besides, this substance is classified as "Eye Dam. 1 H318" in the EU CLP classification (ECHA C&L Inventory (Access on May 2016)).
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- -  From reports that there was no sensitization in Buehler tests (GLP) using guinea pigs (JMPR (2004)) and many reports that there was no sensitization in a maximization test (US EPA and the OECD TG 406, GLP) (EHC 159 (1994), JMPR (2004)), this substance was classified as "Not classified."
5 Germ cell mutagenicity Classification not possible
-
-
- -  The substance was classified as "Classification not possible," because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. As for in vivo, it is reported that a micronucleus test using bone marrow cells of mice and a DNA damage test using the liver and kidney of mice are positive (IARC 112 (2015), JMPR (2004)). However, results are negative in many other tests (a chromosomal aberration test using bone marrow cells of rats, a micronucleus test using bone marrow cells and peripheral blood of mice, a mouse dominant lethal test) (IARC 112 (2015), EPA RED (1993), JMPR (2004), NTP DB (Access on June 2016), Japanese Journal of Pesticide Science (Pesticide Science Society of Japan, 2000)), and the positive results have not been reconfirmed.
 As for in vitro, in a chromosomal aberration test and a sister chromatid exchange test using human peripheral lymphocytes and a micronucleus test using Chinese hamster cultured cells positive results are reported. However, all results are negative in many other tests (a bacterial reverse mutation test, a gene mutation test, a chromosomal aberration test and a micronucleus test using mammalian cultured cells) (IARC 112 (2015), JMPR (2004), EPA RED (1993), IRIS Summary (1987), NTP DB (Access on June 2016), Japanese Journal of Pesticide Science (Pesticide Science Society of Japan, 2000).
 Therefore, it was judged that this substance could not be regarded as mutagenic considering the weight of evidence.
6 Carcinogenicity Classification not possible
-
-
- -  In 2015, IARC classified the carcinogenicity of glyphosate in Group 2A (equivalent to 1B in the GHS classification).
 The rationale was the following: there is limited evidence for non-Hodgkin's lymphoma in humans; there is sufficient evidence indicating carcinogenicity in experimental animals because increases were observed through trend tests in the incidences of renal tubular tumors, haemangiosarcoma, pancreatic islet cell tumors, hepatocellular adenoma, etc. in several studies using mice and rats administered by feeding; and this substance can be judged a genotoxic substance based on the mechanisms of its action (IARC 112 (2015)).
 On the other hand, JMPR concluded that as an evaluation of the residual pesticide, it is considered that there is no genotoxicity and carcinogenicity in the glyphosate (JMPR (2004)). With regard to IARC's evaluation as Group 2A in 2015, EFSA (European Food Safety Authority) and BfR (German Federal Institute for risk assessment) considered that since the possibility that the data on glyphosate used for evaluation by IARC contains not only the data of active ingredient but also the multiple data of formulation, it is not possible to deny the influence of other components and co-formulants other than glyphosate that could give a bias to the evaluation by IARC. Therefore, based on the evaluation results of JMPR, they rebutted by saying that the active ingredient of the glyphosate substance is a non-carcinogen (EFSA explains risk assessment (Access on May 2016)).
 To clarify the reason why the evaluation results of IARC (2015) and JMPR (2004) differed, WHO instructed JMPR to re-evaluate the carcinogenicity of the glyphosate by establishing working groups with experts.
 As a result of the re-evaluation, JMPR concluded that in regard to the results for carcinogenicity studies using experimental animals, glyphosate is not carcinogenic in rats but they could not exclude the possibility that it is carcinogenic in mice at very high doses (JMPR (2016)). As described above, the latest evaluation results by IARC were not supported by other organizations, and it was judged that it was reasonable to consider that this substance cannot be classified at the present time because international discussions are ongoing.
 
7 Reproductive toxicity Not classified
-
-
- -  In seven reproductive toxicity studies including a 2-generation study using rats, even when administered up to 10,000 - 30,000 ppm (668 - 2,150 mg/kg/day), where general toxicities (tissue change on salivary glands in one study, soft stools and dilatation of the cecum in another study) were observed in parental animals, no effects on fertility and sex function were observed. Also there was only a slight suppression of weight gain and a delay in the sexual maturity (males only) in the offspring (JMPR (2016)).
 In developmental toxicity studies, of the four studies involving administration by gavage during the organogenesis period of pregnant rats, even in the most affected tests, only minor effects on the fetuses (delayed ossification and skeletal variations) were observed at 1,000 mg/kg/day where weight gain suppression and loose stools were observed in maternal animals (JMPR (2016)). In seven developmental toxicity studies using pregnant rabbits administered by gavage during the organogenesis period, as the effects at the lowest dose, diarrhea and loose stools were observed in dams at 175 mg/kg/day or higher, and low incidence of malformations (cardiac malformation, absent kidney, etc.) were observed at the dose of maternal toxicity expression. However, JMPR concluded that the effects on the fetus are secondary effects due to maternal toxicity and that this substance does not indicate teratogenicity along with the study results on rats (JMPR (2016)). As described above, there is no effect on fertility in reproductive toxicity tests using rats, and developmental effects in rats and rabbits are minor or secondary effects due to maternal toxicity. It is concluded that there is no teratogenicity.
 Therefore, this substance was classified as "Not classified."
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects)


Warning
H336 P304+P340
P403+P233
P261
P271
P312
P405
P501 		 As for single dose studies using experimental animals, by oral administration (rats, mice), ataxia, lethargy, and piloerection were observed (JMPR (2004)); and by inhalation exposure (rats), salivation, irregular breathing, auditory hypoaesthesia, reduced righting reflex and shaking were observed (JMPR (2004)). Therefore, this substance was classified in Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- -  There is no information on humans.
 As for experimental animals, in six studies (three 90-day repeated dose toxicity studies administered by feeding (two studies using rats, one study using mice), one 1-year repeated dose toxicity study using rats administered by feeding, one 2-year repeated dose toxicity study using rats administered by feeding, and one 2-generation reproductive and developmental toxicity study using rats administered by feeding), hyperplasia or cellular degeneration of salivary gland (parotid and/or submaxillary gland) was observed. However, these were observed at dose levels exceeding the range of Category 2 in all of the tests (JMPR (2004)).
 In JMPR (2004), the effects on the salivary glands is regarded as the target organ; in addition, ADI (0-1.0 mg/kg/day) is established based on a NOAEL of 100 mg/kg/day based on cellular degeneration of the salivary glands in a 2-year repeated dose toxicity study using rats.
 In the previous classification, this substance was classified in Category 2 (salivary gland). However, with regard to the findings, which were the evidence, on the salivary glands at 30 mg/kg/day and 300 mg/kg/day in 13-week study using rats, JMPR (2004) considered them doubtful as toxicological effects because the frequency and degree are only slight. Therefore, the effects at these doses were not adopted as the rationale for classification. From the above, effects on the salivary glands are observed, but it is above Category 2. Therefore, this substance was classified as "Classification not possible."
10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data.

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 1


Warning
H400 P273
P391
P501 		 From 96-hour EC50 = 0.85 mg/L for algae (Skeletonema costatum) (U.S. EPA: RED, 1993), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 1


Warning
H410 P273
P391
P501 		 If chronic toxicity data are used, then it is classified as "Not classified" due to 21-day NOEC = 100 mg/L for crustacea (Daphnia magna), and 21-day NOEC (survival, behavior and so on) = 52 mg/L for fish (Oncorhynchus mykiss) (both EHC 159, 1994), though appropriate data are not obtained on rapid degradability.
 If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to no appropriate data obtained on rapid degradability, and 96-hour EC50 = 0.85 mg/L for algae (Skeletonema costatum) (U.S. EPA: RED, 1993).
 It was classified in Category 1 by drawing a comparison between the above results.
12 Hazardous to the ozone layer Classification not possible
-
-
- -  No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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