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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	51276-47-2
Chemical Name	2-Amino-4-[hydroxy(methyl)phosphinoyl]butyric acid; Glufosinate
Substance ID	R02-B-105-MHLW, MOE
Classification year (FY)	FY2020
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)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available.
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. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
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 contains a metalloid (P), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 1,370 g/L (20 deg C) (Food sanitation research Vol. 52 No. 11 (Japan Crop Protection Association, 2002)).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to the element other than carbon or hydrogen (P). However, the classification is not possible due to no data.
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Because Agricultural Chemical Registration Data (1984) used in the previous classification could not be obtained and confirmed, the classification result was changed from the previous classification. [Reference Data, etc.] (the ammonium salt of this substance (CAS RN 77182-82-2)) (1) LD50 for rats: females: 1,510 mg/kg, males: 1,660 mg/kg (JMPR (2012), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)) (2) LD50 for rats: females: 1,620 mg/kg, males: 2,000 mg/kg (JMPR (2012), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011), HSDB (Access on June 2020)) (3) LD50 for rats: 1,620 mg/kg (GESTIS (Access on June 2020))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Because Agricultural Chemical Registration Data (1984) used in the previous classification could not be obtained and confirmed, the classification result was changed from the previous classification. [Reference Data, etc.] (the ammonium salt of this substance (CAS RN 77182-82-2)) (1) LD50 for rabbits: females: 1,500-2,000 mg/kg, males: > 2,000 mg/kg (JMPR (2012)) (2) LD50 for rats: 1,380 mg/kg (GESTIS (Access on June 2020)) (3) LD50 for rats: > 2,000 mg/kg (JMPR Report (2012)) (4) LD50 for rats: females: 4,000 mg/kg, males: > 4,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), HSDB (Access on June 2020)) (5) LD50 for rats: > 4,000 mg/kg (JMPR (2012))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Because Agricultural Chemical Registration Data (1984) used in the previous classification could not be obtained and confirmed, the classification result was changed from the previous classification. [Reference Data, etc.] (the ammonium salt of this substance (CAS RN 77182-82-2)) (1) LC50 for rats (nose exposure, 4 hours): males: 1.26 mg/L, females: 2.60 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011), HSDB (Access on June 2020)) (2) LC50 for rats (4 hours): 1.26 mg/L (GESTIS (Access on June 2020)) (3) LC50 for rats (4 hours): >= 1.26 mg/L (JMPR Report (2012)) (4) Vapor pressure of the ammonium salt of this substance: 9.1E-012 mmHg (25 deg C) (HSDB (Access on June 2020)) (converted value for the saturated vapor pressure concentration: 9.7E-011 mg/L)
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Because Agricultural Chemical Registration Data (1984) used in the previous classification could not be obtained and confirmed, the classification result was changed from the previous classification. [Reference Data, etc.] (1) In a skin irritation test with rabbits on the ammonium salt of this substance (CAS RN 77182-82-2), no irritation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In a skin irritation test with rabbits on the ammonium salt of this substance (Draize test), it was judged as not an irritant (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Because Agricultural Chemical Registration Data (1984) used in the previous classification could not be obtained and confirmed, the classification result was changed from the previous classification. [Reference Data, etc.] (1) In an eye irritation test with rabbits on the ammonium salt of this substance, no irritation was seen (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In an eye irritation test with rabbits on the ammonium salt of this substance (Draize test), it was judged as not an irritant (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] From (1) - (3), it was classified as "Not classified" based on data on the ammonium salt of this substance (CAS RN 77182-82-2). [Evidence Data] (1) In a mouse local lymph node assay (LLNA) according to OECD TG 429 on the ammonium salt of this substance (CAS RN 77182-82-2), the SI value did not exceed 3, and it was judged as negative (JMPR (2012)). (2) In a skin sensitization test with guinea pigs according to EPA OPP 81-6 on the ammonium salt of this substance (Buehler test, application concentration 50%), it was reported to be negative (JMPR (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). (3) In a skin sensitization test with guinea pigs according to OECD TG 406 on the ammonium salt of this substance (maximization test, intradermal administration 1%), it was reported to be negative (JMPR (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] From (1), (2), it was classified as "Not classified" by using data on the ammonium salt of this substance (CAS RN 778182-82-2). [Evidence Data] (1) As for in vivo, the ammonium salt of this substance was negative in a micronucleus test by single oral administration to mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011), JMPR (2012)). (2) As for in vitro, the ammonium salt of this substance was negative in a bacterial reverse mutation test, negative in a gene mutation test with cultured mammalian cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011), JMPR (2012)), and negative in a chromosomal aberration test with cultured mammalian cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] No classification results by domestic and international organizations or carcinogenicity reports were obtained for this substance, but it was classified as "Not classified" from classification results by other organizations in (1) and animal test results in (2) and (3) for the ammonium salt of this substance. Besides, Agricultural Chemical Registration Data (1986) used in the previous classification could not be obtained and confirmed. [Evidence Data] (1) As for classification results by domestic and international organizations, the ammonium salt of this substance (CAS RN 77182-82-2) was classified in NL (Not Likely To Be Carcinogenic To Humans) by EPA (EPA Annual Cancer Report 2019 (Access on October 2020): classified in 1999). (2) In a combined chronic toxicity/carcinogenicity test by diet administration of the ammonium salt of this substance (CAS RN 77182-82-2) to male and female rats for 2 years and 6 months, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (3) In carcinogenicity tests by 2-year diet administration of the ammonium salt of this substance (CAS RN 77182-82-2) to male and female rats and mice, no carcinogenicity was found (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). [Reference Data, etc.] (4) In the 2-year carcinogenicity test in rats in (3), an increase in the incidence of skin tumors (folliculoma), which were rare tumors, was observed in males in the group dosed at 10,000 ppm, but there was no statistical difference in the combined incidence of tumors that were considered to be derived from hair follicles (pilomatricoma, trichoepithelioma, folliculoma, and keratoacanthoma), and it was considered that the formation of these hair-follicle-derived tumors was not a treatment-related effect (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] There was no data available on this substance, and the data on the ammonium salt of this substance (CAS RN 77182-82-2) was used for the classification. Based on (1) to (3), it was classified in Category 1B. In addition, new information sources was used for evaluation and the classification was changed from the previous classification. [Evidence Data] (1) In a two-generation reproduction study using the ammonium salt of this substance with rats dosed by feeding, at 360 ppm (P generation: 24 mg/kg/day in males, 36 mg/kg/day in females, F1 generation: 24 mg/kg/day in males, 33 mg/kg/day in females), reduced food consumption during the lactation period was observed in dams (P and F1), and a decrease in the number of liveborn pups was observed in P and F1 generations (F1a: 8.8 pups, 11.2 pups in the control group, F1b: 7.4 pups, 11.7 pups in the control group, F2a: 9.6 pups, 10.8 pups in the control group, F2b: 8.2 pups, 11.2 pups in the control group) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011), JMPR (2012)). The pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011) indicated that the decreased number of liveborn pups was considered to be an effect in the early post-implantation stage because no effects on the mating rate, conception rate, fertility rate, birth rate, and gestation period were observed. The Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013) indicated that no effects on fertility were observed. (2) In a developmental toxicity study using the ammonium salt of this substance with female rabbits dosed by gavage on days 7 to 19 of gestation, at a dose (20 mg/kg/day) at which maternal toxicity effects (sacrifice in emergency due to convulsion (1 case), reduced body weight gain (94% relative to the control group), a decrease in food consumption) were observed, premature birth (1 case), deaths of all fetuses (1 case), and only trace of implantation (1 case) were observed, and an increase in the number of deaths of fetuses (control group: 0/litter, 20 mg/kg/day: 0.55/litter) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). (3) In a developmental toxicity study using the ammonium salt of this substance with female rats dosed by gavage on days 6 to 15 of gestation, at a dose (250 mg/kg/day) at which maternal toxicity effects (death (1/20 case), sacrifice due to vaginal bleeding (which was considered to be due to intrauterine death of fetuses and miscarriage: 8/20 cases), vaginal bleeding, hyperactivity, restless movement, unkempt fur, atonicity, etc.) were observed, an increase in the number of fetal deaths and an increase in the incidence of enlargement of the renal pelvis and the ureter (control group: 0.9%, 250 mg/kg/day: 15.7%) were observed, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). [Reference Data, etc.] (4) The ammonium salt of this substance is classified as Repr.1B in the EU CLP classification (Classification in EU CLP (Access on June 2020)).
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] There was no information available on this substance, but it was classified in Category 1 (central nervous system) based on the information on the ammonium salt of this substance (CAS RN 77182-82-2) in (1) to (5). New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) It was reported that, in a case in which this substance or the ammonium salt of this substance was accidentally ingested, disturbed consciousness, respitory distress, convulsions, diabetes insipidus, and circulatory collapse were observed (HSDB (Access on June 2020)). (2) In an acute oral toxicity test using the ammonium salt of this substance with rats, at or above 1,000 mg/kg (converted value to this substance: 914 mg/kg, within the range for Category 2), sedation, nervosity, salivation, lacrimation, prone position, and piloerection were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). (3) In an acute oral toxicity test using the ammonium salt of this substance with rats, hypoactivity, imbalance, crouching, prone position, recumbency, tremors, convulsions, clonic convulsions, convulsive rolling, hyperreflexia, piloerection, Dalrymple's sign, proptosis, formation of red scabs around the eyes and snout, and irregular breathing were observed in males at or above 1,000 mg/kg (converted value to this substance: 914 mg/kg, within the range for Category 2) and in females at or above 1,600 mg/kg (converted value to this substance: 1,462 mg/kg, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). (4) In an acute dermal application test using the ammonium salt of this substance with rats, at or above 4,000 mg/kg (converted value to this substance: 3,656 mg/kg, exceeding Category 2) in males and 2,000 mg/kg (converted value to this substance: 1,828 mg/kg, within the range for Category 2) in females, sensitivity reaction, sedation, convulsion, stupor, imbalance, crouching, toe walking, prone position, tremor, twitching, involution of the abdomen, involution of the ventralis, saltatory spasm, Straub tail, piloerection, palpebral enlargement, salivation, bloody urine, aggressive behavior, chewing behavior, and emaciation were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). (5) In a 4-hour inhalation exposure test using the ammonium salt of this substance with rats (dust, exposure of the nose), at or above 0.19 mg/L (converted value to this substance: 0.17 mg/L, within the range for Category 1) in males and 0.12 mg/L (converted value to this substance: 0.11 mg/L, within the range for Category 1) in females, ptosis, intermittent tremors, clonic convulsion, hyperfunction, piloerection, salivation, and sedation were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)). [Reference Data, etc.] (6) In a 65-year-old male who ingested about 300 mL of the formulation (BASTA) containing 20% of the ammonium salt of this substance, speech ataxia and systemic tremor were observed four and a half hours after the ingestion (HSDB (Access on June 2020)). (7) In a 69-year-old female who took 500 mL of the above-described BASTA (containing 20% of the ammonium salt of this substance) and an 87-year-old male who took 200 mL of the same, convulsions were observed (HSDB (Access on June 2020)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] There was no information on this substance itself, but it was classified in Category 1 (central nervous system) based on the information (1) to (3) on the ammonium salt of this substance (CAS RN 77182-82-2). As a result of examination based on the new information, the classification results were changed from the previous classification. [Evidence Data] (1) It was reported that, in a 28-day inhalation exposure test with rats using the ammonium salt of this substance (6 hours/day, presumably, aerosol exposure), at or above 25 mg/m3 (converted guidance value: 0.008 mg/L (a converted value equivalent to this substance: 0.007 mg/L), within the range for Category 1) in males and at 50 mg/m3 (converted guidance value: 0.016 mg/L (a converted value equivalent to this substance: 0.015 mg/L), within the range for Category 1) in females, sedation, tonic/clonic convulsion, tremor, staggering gait, excitation, aggressive behavior, and bloody urine were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) It was reported that, in a 28-day inhalation exposure test with rats using the ammonium salt of this substance (6 hours/day, 5 days/week, aerosol exposure), at 100 mg/m3 (converted guidance value: 0.031 mg/L (a converted value equivalent to this substance: 0.028 mg/L), within the range for Category 2) in males and females, irritability, restlessness and hypoactivity, and repetitive head movements were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (3) It was reported that, in a one-year oral toxicity study by administration of the ammonium salt of this substance to dogs dosed by feeding, at 8.5 mg/kg/day (converted value equivalent to this substance: 7.8 mg/L, within the range for Category 1), one case of death each in males and females (weakened heart and circulatory organ system due to necrosis of the cardiac muscle), salivation, hyperkinesia, lethargy, a decrease in locomotor activity, tremor, ataxic gait, frequent urination, tonic/clonic convulsion, etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). [Reference Data, etc.] (4) In 90-day oral toxicity studies by administration of the ammonium salt of this substance to rats and mice dosed by feeding, at doses exceeding Category 2, effects on the central nervous system were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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.
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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