Food Safety
Online ISSN : 2187-8404
Risk Assessment Report: Pesticides
Glyphosate
Summary
Food Safety Commission of Japan
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JOURNALS FREE ACCESS FULL-TEXT HTML

2016 Volume 4 Issue 3 Pages 93-102

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Abstract

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of glyphosate (CAS No. 1071-83-6), an amino acid herbicide, based on results from various studies. Major adverse effects of glyphosate were observed on reduced gain of body weight, GI tract (diarrhea, increased cecum weight, bowel dilatation, thickening of intestinal mucosa), and liver (increased alkaline phosphatase (ALP), hepatocellular hypertrophy). Glyphosate had no neurotoxicity, carcinogenicity, reproductive toxicity, teratogenicity, and genotoxicity. As the whole, the lowest value among no-observed-adverse-effect levels (NOAELs) was 100 mg/kg bw/day obtained in the 90-days and one-year toxicity studies in dogs, and in the developmental toxicity studies of rabbits. FSCJ thus established an acceptable daily intake (ADI) for glyphosate at 1 mg/kg bw/day, applying a safety factor of 100 to the NOAEL. The lowest NOAEL for adverse effects elicited by a single oral administration of glyphosate was 1,000 mg/kg bw observed in an acute toxicity studies in rats and mice. It is thus unnecessary to specify an acute reference dose (ARfD), due to the exceeding of the cut off level (500 mg/kg bw).

Conclusion in Brief

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of glyphosate (CAS No. 1071-83-6), an amino acid herbicide, based on results from various studies.

Several technical grades of glyphosate are currently available in Japan. Five-distinct assessment data sets were submitted from each manufacturer. Toxicological profiles were found to be largely consistent among them after the verification individually. The summary of the risk assessment of each technical grade of glyphosate (Glyphosate I to V) is shown in Appendix.

The active ingredient of glyphosate is distributed various salt form such as glyphosate ammonium salt (CAS No. 40465-66-5), glyphosate isopropylamine salt (CAS No. 38641-94-0) and glyphosate potassium salt (CAS No. 70901-12-1). Those salts are soluble in water. Whatever salt are applied to crops, the residue on the crops exists in the form of free acid. FSCJ established the unified acceptable daily intake (ADI) and acute reference dose (ARfD) of glyphosate through compiling these assessment results.

In general, 14C-glyphosate orally administrated rapidly reached to the Cmax value in plasma and then was eliminated in rats. At least 20% of the radioactivity was absorbed and excreted efficiently in feces. Unchanged glyphosate and aminomethyl phosphonic acid (AMPA) were found in urine and feces.

The fates of 14C-glyphosate in livestock (goats and chicken) were also examined. Unchanged glyphosate was found as the major radioactive substance in urine, feces, organs and tissues, and AMPA was also found as the minor component.

On the fate of 14C-glyphosate, and isopropylamine, potassium, trimesium or sodium salt of 14C-glyphosate in plants, AMPA was found more than 10% of the total radioactive residue (TRR). N-Acetylglyphosate and N-acetyl-AMPA were detected in the glyphosate tolerant soybean and corn as more than 10% of TRR.

Major adverse effects of glyphosate were observed on reduced gain of body weight, GI tract (diarrhea, increased cecum weight, bowel dilatation, thickening of intestinal mucosa), and liver (increased alkaline phosphatase (ALP), hepatocellular hypertrophy). Glyphosate had no neurotoxicity, carcinogenicity, reproductive toxicity, teratogenicity, and genotoxicity.

Among no-observed-adverse-effect levels (NOAELs) of each technical grade of glyphosate, the lowest value was 75 mg/kg bw/day on Glyphosate I derived from the maternal effects in the developmental toxicity study of rabbits. FSCJ, however, recognized it appropriate to set 100 mg/kg bw/day as the overall NOAEL in the developmental toxicity studies of rabbits, considering the dose settings and the toxicological effects observed in the four other corresponding studies.

As the whole, the lowest value among NOAELs was 100 mg/kg bw/day obtained in the 90-days and one-year toxicity studies in dogs, and in the developmental toxicity studies of rabbits. FSCJ thus established an ADI for glyphosate at 1 mg/kg bw/day, applying a safety factor of 100 to the NOAEL.

The lowest NOAEL for adverse effects elicited by a single oral administration of glyphosate was 1,000 mg/kg bw observed in an acute toxicity studies in rats and mice. It is thus unnecessary to specify an ARfD, due to the exceeding of the cut off level (500 mg/kg bw).

In plants, AMPA, N-acetyl-AMPA, and N-Acetylglyphosate were observed as exceeded 10% of TRR. N-acetyl-AMPA and N-Acetylglyphosate were not detected in rats. N-acetyl-AMPA had a very low acute toxicity (LD50 was beyond 5,000 mg/kg bw), and no genotoxicity. Thus the residue definition for the dietary risk assessment was identified to be glyphosate and N-Acetylglyphosate in agricultural products, and glyphosate (parent compound only) in livestock products.

Appendix

Glyphosate I

FSCJ conducted a risk assessment of glyphosate (CAS No. 1071-83-6) [glyphosate ammonium salt (CAS No. 40465-66-5), glyphosate isopropylamine salt (CAS No. 38641-94-0) and glyphosate potassium salt (CAS No. 70901-12-1)], an amino acid herbicide, based on results from various studies.

The data used in the assessment include fate in animals (rats and rabbits), fate in plants (soybeans, grapes and others), residues in crops, subacute toxicity (rats, mice and dogs), chronic toxicity (dogs), combined chronic toxicity/carcinogenicity (rats), carcinogenicity (mice), two-generation reproductive toxicity (rats), developmental toxicity (rats and rabbits), and genotoxicity.

Major adverse effects of glyphosate were observed on GI tract (diarrhea, loose feces) and reduced gain of body weight. None of carcinogenicity, reproductive toxicity, teratogenicity and genotoxicity was observed.

Based on the results from various studies, glyphosate (parent compound only) was identified as the relevant substance for the residue definition for dietary risk assessment in agricultural products.

The lowest NOAEL obtained in all the studies was 75 mg/kg bw/day in a developmental toxicity study in rabbits. FSCJ established ADI of 0.75 mg/kg bw/day by applying a safety factor of 100 to the NOAEL.

The lowest NOAEL for adverse effects elicited by a single oral administration of glyphosate was 1,000 mg/kg bw obtained in an acute toxicity study in mice. It is thus unnecessary to specify an ARfD, due to the exceeding of the cut off level (500 mg/kg bw).

Glyphosate II

FSCJ conducted a risk assessment of glyphosate (CAS No. 1071-83-6) [glyphosate potassium salt (CAS No. 70901-12-1)], an amino acid herbicide, based on results from various studies.

The data used in the assessment include fate in animals (rats), fate in plants (paddy rice, lemon and others), residues in crops, subacute toxicity (rats and dogs), subacute neurotoxicity (rats), chronic toxicity (rats and dogs), combined chronic toxicity/carcinogenicity (rats and mice), two-generation reproductive toxicity (rats), developmental toxicity (rats and rabbits), and genotoxicity.

Major adverse effects of glyphosate were observed on reduced gain of body weight and liver (increased alanine aminotransferase (ALT) and ALP). None of neurotoxicity, carcinogenicity, reproductive toxicity, teratogenicity and genotoxicity of glyphosate was observed.

Based on the results from various studies, glyphosate and N-acetylglyphosate were identified as the relevant substance for the residue definition for dietary risk assessment in agricultural products.

The lowest NOAEL obtained in all the studies was 100 mg/kg bw/day in a developmental toxicity study in rabbits. FSCJ established an ADI of 1 mg/kg bw/day by applying a safety factor of 100 to the NOAEL.

The lowest NOAEL for adverse effects elicited by a single oral administration of glyphosate was 1,000 mg/kg bw obtained in an acute neurotoxicity study in rats. It is thus unnecessary to specify an ARfD, due to the exceeding of the cut off level (500 mg/kg bw).

Glyphosate III

FSCJ conducted a risk assessment of glyphosate (CAS No. 1071-83-6) [glyphosate isopropylamine salt (CAS No. 38641-94-0)], an amino acid herbicide, based on results from various studies.

The data used in the assessment include fate in animals (rats), fate in plants (paddy rice, apple and others), residues in crops, subacute toxicity (rats, mice and dogs), subacute neurotoxicity (rats), chronic toxicity (dogs), combined chronic toxicity/carcinogenicity (rats), carcinogenicity (mice), two-generation reproductive toxicity (rats), developmental toxicity (rats and rabbits), and genotoxicity.

Major adverse effects of glyphosate were observed on GI tract (diarrhea, bowel dilatation, thickening of intestinal mucosa), kidney (nephrosis), liver (increased ALP, hepatocellular hypertrophy), and blood (decreased red blood cell (RBC)). None of neurotoxicity, carcinogenicity, reproductive toxicity, teratogenicity, and genotoxicity relevant to human health was observed.

Based on the results from various studies, glyphosate (parent compound only) was identified as the relevant substance for the residue definition for dietary risk assessment in agricultural products.

The lowest NOAEL obtained in all the studies was 100 mg/kg bw/day in a 90-day subacute toxicity study in rats and in dogs, and in a one-year chronic toxicity study in dogs. FSCJ established an ADI of 1 mg/kg bw/day by applying a safety factor of 100 to the NOAEL.

The lowest NOAEL for adverse effects elicited by a single oral administration of glyphosate was 5,000 mg/kg bw obtained in an acute toxicity study in rats and mice. It is thus unnecessary to specify an ARfD, due to the exceeding of the cut off level (500 mg/kg bw).

Glyphosate IV

FSCJ conducted a risk assessment of glyphosate (CAS No. 1071-83-6) [glyphosate isopropylamine salt (CAS No. 38641-94-0)], an amino acid herbicide, based on results from various studies.

The data used in the assessment include fate in animals (rats), fate in plants (paddy rice, apple and others), residues in crops, subacute toxicity (rats, mice and dogs), chronic toxicity (dogs), combined chronic toxicity/carcinogenicity (rats), carcinogenicity (mice), two-generation reproductive toxicity (rats), developmental toxicity (rats and rabbits), and genotoxicity.

Major adverse effects of glyphosate were observed on reduced gain of body weight, GI tract (loose feces, increased cecum weight), and blood (anemia). None of carcinogenicity, reproductive toxicity, teratogenicity and genotoxicity was observed.

Based on the results from various studies, glyphosate (parent compound only) was identified as the relevant substance for the residue definition for dietary risk assessment in agricultural products.

The lowest NOAEL obtained in all the studies was 100 mg/kg bw/day in a developmental toxicity study in rabbits. FSCJ established an ADI of 1 mg/kg bw/day by applying a safety factor of 100 to the NOAEL.

The lowest NOAEL for adverse effects elicited by a single oral administration of glyphosate was 5,000 mg/kg bw obtained in an acute toxicity study in rats and mice. It is thus unnecessary to specify an ARfD, due to the exceeding of the cut off level (500 mg/kg bw).

Glyphosate V

FSCJ conducted a risk assessment of glyphosate (CAS No. 1071-83-6) [glyphosate isopropylamine salt (CAS No. 38641-94-0)], an amino acid herbicide, based on results from various studies.

The data used in the assessment include fate in animals (rats), fate in plants (paddy rice, apple and others), residues in crops, subacute toxicity (rats and dogs), subacute neurotoxicity (rats), chronic toxicity (dogs), combined chronic toxicity/carcinogenicity (rats), carcinogenicity (mice), two-generation reproductive toxicity (rats), developmental toxicity (rats and rabbits), and genotoxicity.

Major adverse effects of glyphosate were observed on GI tract (loose feces and diarrhea). None of neurotoxicity, carcinogenicity, reproductive toxicity, teratogenicity and genotoxicity was observed.

Based on the results from various studies, glyphosate (parent compound only) was identified as the relevant substance for the residue definition for dietary risk assessment in agricultural products.

The lowest NOAEL obtained in all the studies was 200 mg/kg bw/day in a developmental toxicity study in rabbits. FSCJ established an ADI of 2 mg/kg bw/day by applying a safety factor of 100 to the NOAEL.

No adverse effects elicited by a single oral administration of glyphosate was observed. It is thus unnecessary to specify an ARfD.

Levels relevant to toxicological evaluation of glyphosate
Species Study Technical Grade No. Dose
(ppm)
NOAEL
(mg/kg bw/day)
LOAEL
(mg/kg bw/day)
Critical endpoints
(Notes)
Rat 90-day toxicity study I 0, 1,000, 5,000, 20,000a M: 1,270b
F: 1,620b
- No toxicity
0, 200, 2,000, 5,000, 12,500a M: 339
F: 339
M: 839
F: 802
M/F: Reduced gain of body weight, etc
II 0, 1,000, 5,000, 20,000a M: 81.3
F: 90.4
M: 414
F: 447
M/F: Increased ALT, etc
III 0, 100, 300, 1,000, 3,000c
(mg/kg bw/day)
M: 100
F: 300
M: 300
F: 1,000
M/F: loose feces, diarrhea, etc
0, 2,000, 10,000, 50,000a M: 672
F: 736
M: 3,690
F: 3,790
M/F: Hepatocellular hypertrophy, etc
IV 0, 3,000, 10,000, 30,000a M: 168
F: 195
M: 569
F: 637
M/F: Increased cecum weight, etc
V 0, 1,000, 10,000, 50,000a M: 79
F: 90
M: 730
F: 844
M/F: Increased ALP, etc
90-day
neurotoxicity study
II 0, 2,000, 8,000, 20,000a M: 617
F: 1,630b
M: 1,550
F: -
M: Reduced gain of body weight, etc
F: No toxicity
(No subacute neurotoxicity)
III 0, 2,000, 10,000, 50,000a M: 734
F: 858
M: 4,090
F: 5,010
M/F: Diarrhea, etc
(No subacute neurotoxicity)
V 0, 1,000, 5,000, 20,000a M: 1,500b
F: 1,560b
- M/F: No toxicity
(No subacute neurotoxicity)
One-year toxicity study II 0, 2,000, 8,000, 20,000a M: 141
F: 167
M: 560
F: 671
M/F: Increased ALT/ALP, etc
Two-year
combined chronic toxicity/
carcinogenicity study
I 0, 2,000, 8,000, 20,000a M: 362
F: 457
M: 940
F: 1,180
M: Cataract like change
F: Reduced gain of body weight
(Not carcinogenic)
II 0, 2,000, 6,000, 20,000a M: 121
F: 145
M: 361
F: 437
M/F: Increased ALP/ALT, etc
(Not carcinogenic)
III 0, 500, 4,000, 32,000a M: 201
F: 239
M: 1,750
F: 2,000
M/F: Decreased RBC
(Not carcinogenic)
IV 0, 3,000, 10,000, 30,000a M: 104
F: 115
M: 354
F: 393
M/F: Increased absolute cecum weight, etc
(Not carcinogenic)
V 0, 1,500, 5,000, 15,000a M: 1,080b
F: 349
M: -
F: 1,380
M: No toxicity
F: Mineralization of medullary-cortical zone in the kidney
(Not carcinogenic)
(continued.)
Species Study Technical Grade No. Dose
(ppm)
NOAEL
(mg/kg bw/day)
LOAEL
(mg/kg bw/day)
Critical endpoints
(Notes)
Rat
(cont’d)
Two-generation
of reproductive toxicity study
I 0, 2,000, 10,000,
30,000a
PM: 666
PF: 777
F1M: 711
F1F: 804
PM: 1,980
PF: 2,320
F1M: 2,230
F1F: 2,540
P/F1: Reduced gain of body weight, etc
(No effect on reproduction)
II 0, 1,000, 3,000,
10,000a
Parent
PM: 293
PF: 1,050b
F1M: 352
F1F: 1,220b
Offspring
PM: 293
PF: 323
F1M: 352
F1F: 371
Parent
PM: 985
PF: -
F1M: 1,160
F1F: -
Offspring
PM: 293
PF: 1,050
F1M: 352
F1F: 1,220
Parent
M: Reduced gain of body weight, etc
F: No toxicity
Offspring
M/F: Reduced gain of body weight
(No effect on reproduction)
III 0, 400, 4,000,
40,000a
PM: 360
PF: 374
F1M: 480
F1F: 465
PM: 3,810
PF: 3,730
F1M: 5,040
F1F: 4,860
P/F1: Reduced gain of body weight, etc
(No effect on reproduction)
IV 0, 1,200, 6,000,
30,000a
PM: 417
PF: 485
F1M: 458
F1F: 530
PM: 2,150
PF: 2,530
F1M: 2,410
F1F: 2,760
P: Loose feces, dilated caecum, etc
F1: Dilated caecum, etc
(No effect on reproduction)
V 0, 1,500, 5,000,
15,000a
PM: 959b
PF: 1,170b
F1M: 1,170b
F1F: 1,380b
PM: -
PF: -
F1M: -
F1F: -
P/F1: No toxicity
(No effect on reproduction)
Developmental toxicity study I 0, 300,1,000, 3,500c
(mg/kg bw/day)
Maternal/Fetus:
1,000
Maternal/Fetus:
3,500
Maternal: Increased mortality rate, etc
Fetus: Low body weight, etc
(Not teratogenic)
II 0, 250, 500, 1,000c
(mg/kg bw/day)
Maternal/Fetus:
1,000b
Maternal/Fetus:
-
No toxicity
(Not teratogenic)
III 0, 250, 500, 1,000c
(mg/kg bw/day)
Maternal/Fetus:
1,000b
Maternal/Fetus:
-
No toxicity
(Not teratogenic)
IV 0, 30, 300, 1,000c
(mg/kg bw/day)
Maternal: 300
Fetus: 1,000b
Maternal: 1,000
Fetus: -
Maternal: Loose feces, etc
Fetus: No toxicity
(Not teratogenic)
V 0, 100, 500, 1,000c
(mg/kg bw/day)
Maternal/Fetus:
1,000
Maternal/Fetus:
-
No toxicity
(Not teratogenic)
(continued.)
Species Study Technical Grade No. Dose
(ppm)
NOAEL
(mg/kg bw/day)
LOAEL
(mg/kg bw/day)
Critical endpoints
(Notes)
Mouse 90-day toxicity study I 0, 5,000, 10,000, 50,000a M: 1,870
F: 2,740
M: 9,700
F: 14,800
M/F: Reduced gain of body weight
III 0, 2,000, 10,000, 50,000a M: 1,630
F: 423
M: 7,990
F: 1,960
M: Loose feces, bloody feces, etc
F: Decreased absolute/relative kidney weight
IV 0, 5,000, 10,000, 50,000a M: 600
F: 765
M: 1,220
F: 1,490
M/F: Increase trend in cecum weight
Two-year
combined chronic toxicity/
carcinogenicity study
II 0, 100, 1,000, 8,000a M: 118
F: 159
M: 991
F: 1,340
M/F: Reduced gain of body weight
(Not carcinogenic)
18-month carcinogenicity study I [2 year]
0, 1,000, 5,000, 30,000a
M: 830
F: 979
M: 4,930
F: 6,130
M/F: Reduced gain of body weight
(Not carcinogenic)
III 0, 500, 5,000,
50,000a
M: 685
F: 909
M: 7,470
F: 8,690
M/F: Loose feces, etc
(Not carcinogenic)
IV 0, 1,600, 8,000, 40,000a M: 838
F: 153
M: 4,350
F: 787
M: Increased absolute/relative cecum weight, etc
F: Reduced gain of body weight, etc
(Not carcinogenic)
V 0, 500, 1,500, 5,000a M: 810b
F: 1,080b
M: -
F: -
No toxicity
(Not carcinogenic)
Rabbit Developmental toxicity study I 0, 75, 175, 350c
(mg/kg bw/day)
Maternal: 75
Fetus: 350b
Maternal: 175
Fetus: -
Maternal: Diarrhea, loose feces
Fetus: No toxicity
(Not teratogenic)
II 0, 100, 175, 300c
(mg/kg bw/day)
Maternal: 100
Fetus: 175
Maternal: 175
Fetus: 300
Maternal: Reduced gain of body weight, etc
Fetus: Low body weight, etc
III 0, 87.5, 175, 350c
(mg/kg bw/day)
Maternal/Fetus:
350
Maternal/Fetus:
-
No toxicity
(Not teratogenic)
IV 0, 10, 100, 300c
(mg/kg bw/day)
Maternal: 100
Fetus: 300b
Maternal: 300
Fetus: -
Maternal: Loose feces, abortion/premature birth (2 cases), reduce trend in body weight gain
Fetus: No toxicity
(Not teratogenic)
V 0, 50, 200, 400c
(mg/kg bw/day)
Maternal: 200
Fetus: 400b
Maternal: 400
Fetus: -
Maternal: Death, diarrhea, reduced gain of body weight, etc
Fetus: No toxicity
(Not teratogenic)
(continued.)
Species Study Technical Grade No. Dose
(ppm)
NOAEL
(mg/kg bw/day)
LOAEL
(mg/kg bw/day)
Critical endpoints
(Notes)
Dog 90-day toxicity study I [6-month]
0, 10, 60, 300c
(mg/kg bw/day)
M: 300b
F: 300b
M: -
F: -
No toxicity
II 0, 2,000, 10,000, 50,000a M: 323
F: 334
M: 1,680
F: 1,750
M: Decreased Alb, TP, etc
F: Increased ALP
III 0, 30, 100, 300c
(mg/kg bw/day)
M: 100
F: 100
M: 300
F: 300
M/F: Reduce gain of body weight, etc
IV 0, 1,600, 8,000, 40,000a M: 1,020b
F:1,010b
M: -
F: -
No toxicity
V 0, 30, 300, 1,000c
(mg/kg bw/day)
M: 300
F: 300
M: 1,000
F: 1,000
M/F: Loose watery feces, etc
One-year toxicity study I 0, 20, 100, 500c
(mg/kg bw/day)
M: 500b
F: 500b
M: -
F: -
No toxicity
II 0, 3,000, 15,000, 30,000a M: 907b
F: 448
M: -
F: 926
M: No toxicity
F: Reduced gain of body weight
III 0, 30, 100, 300c
(mg/kg bw/day)
M: 100
F: 100
M: 300
F: 300
M/F: Diarrhea, bloody feces, etc
IV 0, 1,600, 8,000, 50,000a M: 182
F: 184
M: 1,200
F: 1,260
M/F: Loose feces, reduce trend in body weight gain, etc
V 0, 30, 125, 500c
(mg/kg bw/day)
M: 500b
F: 500b
M: -
F: -
No toxicity
Genotoxicity I No evidence of genotoxicity
II No evidence of genotoxicity
III No genotoxicity relevant for human health
[Pseudo positive in in vitro chromosomal aberration test (+S9), but negative in in vivo micronucleus test up to the highest dose in accordance with OECD TG.]
IV No evidence of genotoxicity
V No evidence of genotoxicity

M, Male; F, Female; M/F, both sexes; PM, Male in P (Parent) generation; PF, Female in P generation; F1M, Male in F1 generation; F1F, Female in F1 generation; -, No effect observed at the highest dose tested; a, Dietary administration; b, Highest dose tested; c, Gavage administration; Alb, Albumin; TP, Total protein.

Absorption, distribution, excretion and metabolism of glyphosate in animalsKinetics
Dose
(mg/kg bw)
1 10 25 100
Sex Male Female Male Female Male Female Male Female Male Female
Tmax (hr) 3.9 8 4 1.7 6 3 4 4 2 2
Cmax (μg/g) 0.016 0.037 0.168 0.413 0.125 0.162 0.29 0.74 5.61 5.94
T1/2 (hr) 10.9 8.07 18 12 - -
 α (hr) - - - - 2.3 2
 β (day) - - - - - 2.6
AUC 0.257a
(hr μg/
mL)
0.338a
(hr μg/
mL)
245
(min μg/mL)
226
(min μg/mL)
4.6a
(hr μg/g)
9.5a
(hr μg/g)
46.9b
(hr μg/
mL)
64.1b
(hr μg/
mL)
Rate of
absorption (%)
28.1–32.5 30.2–36.2 19–30 39.9 22.9–36.2

/: Not measured; -: Not indicated; a: AUC0-24 hr

Distribution in tissues
Dose
(mg/kg bw)
Hours after administration
(hrsa)
Sex Organ (μg/g)
1 72 Male Bone (0.123), Gastro-intestinal tract (0.031), Kidney (0.020), Carcassb (0.016), Liver (0.012), Others (0.010>)
Female Bone (0.112), Gastro-intestinal tract (0.075), Carcass (0.024), Skin (0.014), Liver (0.012), Kidney (0.012), Others (0.010>)
10 72 Male Bone (0.511), Gastro-intestinal tract (0.152), Kidney (0.068), Carcass (0.062), Liver (0.059), Others (0.05>)
Female Bone (0.395), Gastro-intestinal tract (0.152), Carcass (0.056), Kidney (0.049) Liver (0.044), Others (0.03>)
168 Male Bone (0.552), Carcass (0.106), Others (0.05>)
Female Bone (0.313), Carcass (0.087), Others (0.05>)
Male Bone(0.47), Bone marrow(0.044), Kidney(0.035), Carcass (0.034),
Gastro-intestinal tract (0.030), Others (0.03>)
Female Bone (0.58), Bone marrow (0.093), Gastro-intestinal tract (0.032), Carcass (0.028), Lymph node (0.028), Others (0.025>)
25 120 Male Bone (1.29), Large intestine (0.555), Carcass (0.294), Liver (0.216), Small intestine (0.206), Kidney (0.202), Others (0.2>)
Female Bone (2.31), Stomach (0.796), Liver (0.333), Kidney (0.320),
Urinary bladder (0.282), Lung (0.234), Small intestine (0.221),
Carcass (0.201), Others (0.2>)
100 168 Male Liver (0.518), Kidney (0.483), Stomach (0.424), Others (0.4>)
Female Stomach (0.600), Kidney (0.440), Liver (0.416), Others (0.4>)

a, After single oral administration; b, Remaining without organs/tissues.

Metabolism

In both urine and feces samples, the major radioactive component was unchanged glyphosate (urine: 15.2–31.0% of administrated dose, feces: 67.6–83.0% of administrated dose). Small amounts of aminomethyl phosphonic acid (AMPA), 0.06–0.66% of administrated dose in urine, trace-1.4% of administrated dose in feces) and methyl aminomethyl phosphonic acid (MAMPA) were detected.

Excretion
Dose
(mg/kg bw)
1a 10b 10a 25c 100a
Sex Male Female Male Female Male Female Male Female Male Female Male Female
Urine (%) 18.4 27.2 13.3 11.0 28.6 22.5 22.5 19.4 42.9 61.4 55.5 36.2
Feces (%) 72.6 62.4 88.5 88.7 62.4 69.4 74.6 84.3 47.3 32.0 43.5 62.9
Dose
(mg/kg bw)
100a 250c 600a 1,000b 1,000a
Sex Male Female Male Female Male Female Male Female Male Female Male Female
Urine (%) 39.4 43.1 42.0 39.9 30.3 29.5 16.8 17.7 17.8 14.3 23.0 22.9
Feces (%) 41.2 42.4 49.2 55.6 74.7 74.2 89.6 84.5 68.9 69.4 75.6 76.6

a, During 168 hrs after single oral administration; b, During 72 hrs after single oral administration; c, During 48 hrs after single oral administration.

 
© 2016 Food Safety Commission, Cabinet Office, Government of Japan
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