GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 77182-82-2
Chemical Name 2-Amino-4-[hydroxy(methyl)phosphoryl]butanoic acid,ammonium salt; Glufosinate-ammonium
Substance ID R02-A-007-MHLW
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised New
Classification result in other fiscal year  
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 data obtained: water solubility of 1,370 g/L (20 deg C) (Fed. Chem. Toxic. vol.28 no.5 Japan Crop Protection Association (1990)).
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) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
[Rationale for the Classification]
It was classified in Category 4 from (1) - (3).

[Evidence Data]
(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) Category 4


Warning
H312 P302+P352
P362+P364
P280
P312
P321
P501
[Rationale for the Classification]
It was classified in Category 4 from (1) - (5).

[Evidence Data]
(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) Category 4


Warning
H332 P304+P340
P261
P271
P312
[Rationale for the Classification]
It was classified in Category 4 from (1) - (3).
Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (9.7E-011 mg/L), the reference value in the unit of mg/L was applied as dust.

[Evidence Data]
(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 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 Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) In skin irritation tests with rabbits on this substance by 24-hour semi-occlusive application or by methods according to OECD TG 404, only erythema was observed in part of the animals, and it was judged as not irritating (JMPR (2012), Japan Crop Protection Association Fed. Chem. Toxic. vol.28 no.5 (1990)).
(2) No irritation was observed in an eye irritation test and a skin irritation test with rabbits on this substance (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (3).

[Evidence Data]
(1) In an eye irritation test on this substance according to OECD TG 405, iridial and conjunctival irritation was observed and disappeared by 10 days after application, and it was judged as not irritating (JMPR (2012), Japan Crop Protection Association Fed. Chem. Toxic. vol.28 no.5 (1990)).
(2) In an eye irritation test with rabbits on this substance, slight iridial irritation, conjunctival redness, swelling of the lids and nictitating membranes, and discharge were observed but disappeared by 3 days after application, and it was judged as not irritating (JMPR (2012)).
(3) No irritation was observed in an eye irritation test and a skin irritation test with rabbits on this substance (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), 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]
It was classified as "Not classified" from (1) - (3).

[Evidence Data]
(1) In a local lymph node assay (LLNA) in mice on this substance according to OECD TG 429, the SI value did not exceed 3, and it was judged as negative (JMPR (2012)).
(2) This substance was reported to be negative in a skin sensitization test with guinea pigs (Buehler test, application concentration 50%) according to EPA OPP 81-6 (JMPR (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2011)).
(3) This substance was reported to be negative in a skin sensitization test with guinea pigs (maximization test, intradermal administration 1%) according to OECD TG 406 (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]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, in a micronucleus test with mice dosed by single oral dose, negative results were reported (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, in a bacterial reverse mutation test, and a mammalian cell gene mutation test, negative results were reported (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 in a chromosomal aberration test, negative results were reported (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]
Based on (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) As for the classification results by domestic and international organizations, the EPA classified this substance in NL (Not Likely To Be Carcinogenic To Humans) (EPA Annual Cancer Report 2019 (Access on October 2020): Classification in 1999).
(2) In a combined chronic toxicity/carcinogenicity study by diet administration of this substance to male and female rats for two years and six months, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).
(3) In two-year carcinogenicity studies by administration of this substance to male and female rats and mice dosed by feeding, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)).

[Reference Data, etc.]
(4) In the two-year carcinogenicity study with rats in (3), in males of the group treated at 10,000 ppm, an increase in the incidence of ecphyma (folliculoma), which was a rare tumor, was observed, but there was no statistically significant difference in the total incidences of tumors (hair-matrix tumor, trichoepithelioma, folliculoma and keratoacanthoma) that were considered to be derived from hair follicles. Therefore, these follicular tumors found were considered not treatment-related (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]
Based on (1) to (3), it was classified in Category 1B.

[Evidence Data]
(1) In a two-generation reproduction study 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), a decrease in 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: 11.2 pups in the control group, 8.8 pups in the treatment group, F1b: 11.7 pups in the control group, 7.4 pups in the treatment group, F2a: 10.8 pups in the control group, 9.6 pups in the treatment group, F2b: 11.2 pups in the control group, 8.2 pups in the treatment 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 effect on the copulation index, female fertility index, male fertility index, delivery index, 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 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), death of all fetuses (1 case), and only a trace of implantation (1 case) were observed and an increase in the number of fetal deaths (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 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 caused by 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) In the EU CLP classification, it was classified as Repr.1B (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]
Based on (1) to (4), it was classified in Category 1 (central nervous system).

[Evidence Data]
(1) In an acute oral toxicity test with rats, at or above 1,000 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)).
(2) In an acute oral toxicity test with rats, at or above 1,000 mg/kg in males and 1,600 mg/kg in females (both within the range for Category 2), hypoactivity, imbalance, crouching, prone position, recumbency, tremor, convulsion, clonic convulsion, spastic rolling, hyperreflexia, piloerection, Dalrymple's sign, proptosis, formation of red scabs around the eyes and snout areas, and irregular breathing 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 dermal application test with rats, at or above 4,000 mg/kg (exceeding Category 2) in males and 2,000 mg/kg (the upper limit of Category 2) in females, sensitivity reaction, sedation, convulsion, stupor, imbalance, crouching, toe walking, prone position, tremor, twitching, involution of the abdomen, involution of the ventral abdomen, spastic jumping, 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)).
(4) In a 4-hour inhalation exposure test with rats (dust, exposure of the nose), at or above 0.19 mg/L in males and 0.12 mg/L in females (both within the range for Category 1), 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.]
(5) In a 65-year-old male who ingested about 300 mL of the formulation (BASTA) containing 20% of this substance, speech disorder and systemic tremor were observed after four and a half hours from the ingestion (HSDB (Access on June 2020)).
(6) In a 69-year-old female who took 500 mL of the above-described BASTA (containing 20% 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]
Based on (1) to (3), it was classified in Category 1 (central nervous system).

[Evidence Data]
(1) It was reported that in a 28-day inhalation exposure test with rats using this substance (6 hours/day, presumably, aerosol exposure), at or above 25 mg/m3 (converted guidance value: 0.008 mg/L, within the range for Category 1) in males and at 50 mg/m3 (converted guidance value: 0.016 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 this substance (6 hours/day, 5 days/week, aerosol exposure), at 100 mg/m3 (converted guidance value: 0.031 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 one-year oral toxicity studies by administration of this substance to dogs dosed by feeding, at 8.5 mg/kg/day (within the range for Category 1), deaths of one male and one female (weakened heart and circulatory organ system due to necrosis of the cardiac muscle in dead animals), salivation, hyperkinesia, lethargy, reduced 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 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) -
-
-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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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