GHS Classification Result

Chemical Name：glyphosate (ISO); N-(phosphonomethyl)glycine
CAS：1071-83-6

Result：
ID: 20A2213
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Solid (room temperature)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (room temperature)
5 Gases under pressure Not applicable - - - - Solid (room temperature)
6 Flammable liquids Not applicable - - - - Solid (room temperature)
7 Flammable solid Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Classification not possible - - - - The substance contains chemical groups (P-O) associated with self-reactive properties. Classification is not possible due to lack of data.
9 Pyrophoric liquids Not applicable - - - - Solid (room temperature)
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 - - - - Its water solubility is mentioned in the literature (Merck 14th, 2006; HSDB, 2006; Ullmanns (E) 6th, 2003); it is stable in the water.
13 Oxidizing liquids Not applicable - - - - Solid (room temperature)
14 Oxidizing solids Classification not possible - - - - No data available.
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 Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Not classified - - - - Reviewing List 1 datasets, there are five datasets in which its rat LD50 values are > 5000 mg/kg bw (EHC, 1994; JMPR, 2004), and one dataset in which LD50 is 5600 mg/kg bw (JMPR, 2004). Based on these values, the substance was classified into "Not classified".
1 Acute toxicity （Dermal） Not classified - - - - Its rat LD50 value is > 2000 mg/kg bw (EHC, 1994) and its rabbit LD50 value is > 5000 mg/kg bw, which was consistent among three datasets (EHC, 1994; JMPR, 2004). Based on these values the substance was classified into "Not classified".
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 - - - - Its rat LC50 values (4h) are > 4.98 mg/L (no mortality) and > 4.43 mg/L (two out of five rats of both sexes combined died or were dying) (JMPR, 2004). Based on its saturated vapour pressure of 2.6*10^-9 mg/L (vapour pressure: 2.89*10^-10 mmHg, Howard, 1997), it is estimated that the substance tested was in a dust state. Since it is difficult to determine if these LC50 values fall under Category 4 or "Not classified," the substance was classified into "Classification not possible".
2 Skin corrosion/irritation Not classified - - - - In rabbit tests (complied with the US EPA guidelines or OECD TG 404, GLP), the substance was found to be slightly irritating (EHC, 1994). However, its Draize score of 0.8 is equivalent to "Not classified". In other studies, four rabbit tests (complied with the US EPA guidelines or OECD TG 404, GLP) all concluded that the substance was not irritating (EHC, 1994; JMPR, 2004). Thus, the substance was classified into "Not classified".
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician. 		Among three rabbit tests conducted (complied with the US EPA guidelines or OECD TG 405, GLP), there were cases in which some symptoms did not recover during the 21-day observation period. In the first test, corneal opacity and conjunctival irritation with blistering (all of 6 animals treated), pannus of the cornea (3 of 6 animals treated), vascularization of the conjunctiva (1 of 6 animals treated), and blood like discharge (1 of 6 animals treated) were observed; and 3 of 5 animals developed these symptoms did not recover in 21 days (EHC, 1994). In the second test, all animals showed corneal opacity, conjunctival redness, and chemosis, and these symptoms persisted for 21 days (JMPR, 2004). Similarly, in the third test, symptoms related to the cornea, iris and conjunctiva were observed, and mild reaction to the treatment by the cornea persisted for 21 days (EHC, 1994). Based on these results, the substance was classified into Category 1. The substance has been rated R41 in the EU classification, which is equivalent to Category 1.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Not classified - - - - Buehler tests using guinea pigs (GLP tests) concluded that the substance was not sensitizing (JMPR, 2004); and likewise, two maximization tests (complied with the US EPA guidelines or OECD TG 406, GLP) did not show a sign of sensitization (JMPR, 2004; EHC, 1994). Thus, the substance was classified into "Not classified".
5 Germ cell mutagenicity Not classified - - - - Negative results were obtained from several micronucleus tests using mice (three oral route, and one intraperitoneal tests) (in vivo mutagenicity tests using somatic cells), and dominant lethal tests using mice (in vivo heritable mutagenicity tests using germ cells) (JMPR (2004)). Based on these results, the substance was classified into "Not classified". Also, weakly positive results were obtained from a micronucleus test using mice that underwent intraperitoneal administration, and positive results were also shown in DNA damage tests (JMPR (2004)). On the other hand, in in vitro tests, many negative results have been recorded in Ames tests (JMPR (2004)), mouse lymphoma assays (JMPR (2004)), HGPRT tests using CHO cells (HSDB (2006)), and cytogenetical tests using human lymphocytes (JMPR, 2004).
6 Carcinogenicity Not classified - - - - In two-year mixed diet tests using rats (SD) (complied with the US EPA guidelines or OECD TG 453, GLP), a significant increase in rates of developing pancreatic islet cell adenomas was observed in male animals treated with low doses. However, there is a description that "the incidence in the control group was below the historical control range; the trend test for the observed increase was negative. No pancreatic carcinomas were found" (EHC, 1994), referring to the same test, the JMPR concluded that "administration of glyphosate to Sprague-Dawley rats for 24 months produced no signs of carcinogenic potential." (JMPR, 2004). Similarly, in two-year mixed diet tests using rats (Alpk: APfSD) (Wistar-derived) (complied with the US EPA guidelines or OECD TG 453, GLP), no statistically significant, dose-dependent increase in rates of developing tumors was observed (JMPR, 2004). Likewise, in 104-week mixed diet tests using mice (complied with the US EPA guidelines or OECD TG 451, GLP), a statistically significant increase in rates of developing tumors was not detected in either sex (JMPR, 2004). In addition, the substance is rated as D in the EPA's carcinogenicity classification, which is equivalent to "Not classified". Based on these results, the substance was classified into "Not classified".
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Of two teratogenicity tests using rabbits conducted (OECD TG 414, GLP), one test resulted in increased embryotic deaths, an increase in rates of postimplantation loss, and a few cases of interventricular septal defect and other abnormalities affecting the heart in fetuses at the doses (150 and 450 mg/kg bw /day) that induce general toxicity in parental animals (reduction in food intake, soft/liquid feaces, or body weight loss) (JMPR, 2004). In the other test, a partial ossification (vertebrae and sternebra) and reduction in ossification (manus) were observed in fetuses at the dose (300 mg/kg bw /day) that induces general toxicity in parental animals (reduced food consumption, diarrhea, or suppressed body weight gain). However, these toxic effects were detected only at low and high doses and not at intermediate doses (JMPR, 2004). In two-generation reproductive toxicity tests (complied with the US EPA guidelines or OECD TG 416, GLP), no effect on sexuality and fertility were observed at the doses that induce general toxicity in parental animals (decreased food and water consumptions, lower body weight, or cellular alterations of the salivary gland) (JMPR, 2004). In teratogenicity tests using rats (complied with the US EPA guidelines or OECD TG 414, GLP), a slight increase in reduced ossification and skeletal variation (wavy ribs) was observed in fetuses at the dose (1000 mg/kg bw /day) that induces general toxicity in parental animals (suppressed body weight gain and respiratory changes) (JMPR, 2004). However, in a different teratogenicity test using rats (OECD TG 414, GLP), no effects were observed in either parental animals or fetuses at the same dose (1000 mg/kg bw / day). There is a comment by the JMPR that "the existing database on glyphosate was adequate to characterize the potential hazards to fetuses, infants, and children." Based on these results, the substance was classified into Category 2.
8 Specific target organ toxicity - Single exposure Category 3 （Narcotic effects） Warning H336: May cause drowsiness or dizziness (narcotic effects) P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Through oral route exposure, signs of inactivity were observed in two rat tests while signs of lethargy and sedation were observed in two mouse tests (JMPR, 2004). Through dermal route exposure, these signs (reduced activity and sedation) were not detected in either rats or rabbits (JMPR, 2004). Through inhalation exposure in two rat tests, animals were slightly subdued in one test; however, auditory hypoaesthesia and a reduced righting reflex, as well as irregular breathing were observed in the other test (JMPR, 2004). Furthermore, at the administration dose of 4.43 mg/L (4h), dark lungs were detected in cases of death (two of five dead males) (JMPR, 2004). Based on these results, the substance was classified into Category 3 (narcotic effects) in terms of oral and inhalation route exposure.
9 Specific target organ toxicity - Repeated exposure Category 2 (salivary gland) Warning H373: May cause damage to organs through prolonged or repeated exposure (salivary gland) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		In 13-week repeated oral administration tests using rats (complied with the US EPA guidelines or OECD TG 408, GLP), cellular alterations in the parotid salivary gland was observed at the administration dose of 30 mg/kg bw /day or higher, and its rate of occurrence and the degree of severity increased in a dose-dependent fashion (JMPR, 2004). Similarly, in a different 104-week repeated oral administration test using rats (the US EPA guidelines, GLP), cytoplasmic alteration in the parotid and submandibular salivary glands was observed at the administration dose of 100 mg/kg bw /day or higher in a dose-dependent fashion (JMPR, 2004). Thus, the substance was classified into Category 2 (salivary gland) in terms of oral route exposure. In addition, in three-week repeated dermal administration tests using rabbits (GLP), no effects were observed at 100 mg/kg bw /day or higher in terms of hematology, blood biochemistry, organ weight, and pathological test.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Since its 96-hour EC50 = 1.2 mg/L for diatoms (Skeletonema) (EHC 159, 1994), the substance was classified into Category 2.
11 Hazardous to the aquatic environment （Long-term） Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Since reliable rapid degradability data are not available for this substance, and its preexisting rating for acute toxicity is Category 2, it was classified into Category 2.


NOTE:
* 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.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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