GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 23422-53-9 |
| Chemical name | Formetanate hydrochloride |
| Substance ID | 23A5097 |
| Fiscal year of classification conducted | FY2011 |
| Classifier(s) (Ministries) | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| New/Revised | New |
| Download in Excel format | Excel file |
| Item | Information |
|---|---|
| Guidance used for classification (External link) |
Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government （July, 2010）
Environmental Hazards: UN GHS Document （4th revised edition） |
| 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 |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
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 | - | - | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable | - | - | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Not classified | - | - | - | It was classified as "Not classified" from the information that it is "not flammable" (PM (14th, 2006)). |
| 8 | Self-reactive substances and mixtures | Not applicable | - | - | - | There are no chemical groups associated with explosive or self-reactive properties present in the molecule. |
| 9 | Pyrophoric liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Not classified | - | - | - | It was classified as "Not classified" because it does not ignite spontaneously on coming into contact with air at normal temperatures from the information that it is "not flammable" (PM (14th, 2006)). |
| 11 | Self-heating substances and mixtures | Not classified | - | - | - | It was classified as "Not classified" from the information that it is "not flammable" (PM (14th, 2006)). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - | Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Not applicable | - | - | - |
An organic compound that contains oxygen and chlorine. It is conceivable that the oxygen which is not chemically bonded to elements other than carbon and the chlorine which is chlorine ion ionically bonded to amine don't contribute to the oxidation of other substances. |
| 15 | Organic peroxides | Not applicable | - | - | - | An organic compound that does not contain -O-O- structure. |
| 16 | Corrosive to metals | Classification not possible | - | - | - | No established test method suitable for solid substances. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 2 |  |
H300 |
P301+P310 P264 P270 P321 P330 P405 P501 |
From an LD50 value of 14.8 mg/kg bw for rats (EPA RED (2007)), it was classified in Category 2. |
| 1 | Acute toxicity （Dermal） | Not classified | - | - | - | Both of an LD50 value of > 5600 mg/kg for rats and an LD50 value of > 10200 mg/kg for rabbits (Evaluation of effect for the food safety (Access on July. 2011)) correspond to "Not classified." |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - |
The classification is not possible because the category cannot be determined from a reported LC50 value of > 0.15 mg/L/4h for rats (Evaluation of effect for the food safety (Access on July. 2011)). Besides, a reference value of dust was applied because the toxicity value (0.15 mg/L) is higher than the saturated vapour pressure concentration. |
| 2 | Skin corrosion/irritation | Not classified | - | - | - |
It was classified as "Not classified" from the information that it is not a skin irritant in a summary of risk assessment (EPA RED (2007)) and the information that it did not irritate the skin of rabbits (HSDB (2010)). Besides, there is the information that irritation was observed in a skin irritation test (unknown animal species) (Evaluation of effect for the food safety (Access on July. 2011)). |
| 3 | Serious eye damage/eye irritation | Not classified | - | - | - |
It was classified as "Not classified" from the information that it is not an eye irritant in a summary of risk assessment (EPA RED (2007)). Besides, there is the information that it caused moderate reversible irritation to rabbit eyes (HSDB (2010)) while there is the information that irritation was not observed in an eye irritation test (unknown animal species) (Evaluation of effect for the food safety (Access on July. 2011)). |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | No data. |
| 4 | Skin sensitization | Category 1 |  |
H317 |
P302+P352 P333+P313 P261 P272 P280 P321 P363 P501 |
It was classified in Category 1 because it was reported that sensitization was observed in a skin sensitization test using guinea pigs (Buehler test) (Evaluation of effect for the food safety (Access on July. 2011)) and there is the information that it is a dermal sensitizer in a summary of risk assessment (EPA RED (2007)). Besides, it is classified in R43 in EU classification (EC-JRC (ESIS) (Access on August. 2011)). |
| 5 | Germ cell mutagenicity | Not classified | - | - | - |
From negative results in a chromosomal aberration test using mammalian spermatogonial cells (in vivo germ cell mutagenicity test) and a micronucleus test using mice (in vivo mutagenicity test) (Evaluation of effect for the food safety (Access on July. 2011)), it was classified as "Not classified." Besides, as in vitro tests, a negative in an Ames test and positives in a chromosome aberration test using human lymphocytes and a mouse lymphoma test were reported. (above Evaluation of effect for the food safety (Access on July. 2011)) |
| 6 | Carcinogenicity | Not classified | - | - | - |
It was classified as "Not classified" from Group E classification by EPA (EPA RED (2007)). Besides, it is reported that carcinogenicity was not observed in a 2-year combined chronic toxicity test with carcinogenicity test using rats (Evaluation of effect for the food safety (Access on July. 2011)) and in a 22-month carcinogenicity test using mice (Evaluation of effect for the food safety (Access on July. 2011)). |
| 7 | Reproductive toxicity | Category 2 |  |
H361 |
P308+P313 P201 P202 P281 P405 P501 |
From whole blood cholinesterase (ChE) activity inhibition and so on as general toxicity observed in a high dose group at 250 ppm in parent animals and a decreased fetal survival rate at the same dose (Evaluation of effect for the food safety (Access on July. 2011)) in a two-generation diet administration reproductive test in rats, it was classified in Category 2. Other effects on fertility were not observed. Furthermore, in an oral administration test during an organogenetic period in rats and rabbits, no dose-related toxic symptoms including teratogenicity in fetuses at doses where general toxicity such as decreased weight gain was observed in maternal animals were observed. (Evaluation of effect for the food safety (Access on July. 2011)) |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (nervous system) | |
H371 |
P309+P311 P260 P264 P270 P405 P501 |
In an oral dose acute neurotoxicity test in rats, tremor, ataxic gait, abnormal gait, decreased locomotor activity, decreased arousal, mydriasis, salivation, decreased rearing, decreased toe and tail pinch responses, decreased and increased auditory startle reaction were observed in a 10 mg/kg dose group. And ChE activity inhibition (not less than 20%) was observed in dose groups of 1 mg/kg or higher. (Evaluation of effect for the food safety (Access on July. 2011)) Judging from guidance values, it corresponds to Category 1, but it was classified in Category 2 (nervous system) in conformity to Guidance because data are from List 2 and it does not meet Decision Criteria 1b3) (OECD TG test and GLP). Besides, there is the information that the primary mode of toxic action of this substance which is a carbamate pesticide is through cholinesterase inhibition after single or repeated exposure. (EPA RED (2007)) |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (nervous system) | |
H373 |
P260 P314 P501 |
The primary mode of toxic action of this substance which is a carbamate pesticide is through cholinesterase inhibition after single or repeated exposure. (EPA RED (2007)) In a 2-year diet administration test in rats, ChE activity inhibition in whole blood and brain (not less than 20%) at doses of 50 ppm (2.3 to 2.9 mg/kg bw/day) or higher was reported. And in a 1-year diet administration test in dogs, excessive salivation, dyspnea, tremor, cough, and sedation in addition to whole blood ChE activity inhibition (not less than 20%) at doses of 50 ppm (1.74 to 1.78 mg/kg bw/day) or higher were reported. (Evaluation of effect for the food safety (Access on July. 2011)) From the above results, it was classified in Category 2 (nervous system) in conformity to Guidance because the ChE activity inhibition observed at a dose corresponding to Category 1 in Guidance values is from List 2 data and it does not meet Decision Criteria 1b3) (OECD TG test and GLP). |
| 10 | Aspiration hazard | Classification not possible | - | - | - | No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Category 1 |  |
H400 |
P273 P391 P501 |
It was classified in Category 1 from 48-hour EC50 = 0.0868 mg/L for crustacea (Daphnia magna) (AQUIRE, 2012). |
| 11 | Hazardous to the aquatic environment （Long-term） | Category 1 | |
H410 |
P273 P391 P501 |
Reliable chronic toxicity data were not obtained. Due to lack of rapid degradability (BIOWIN), and acute toxicity Category 1, it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - | This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* Hazard statement or Precautionary statement will show when hovering the mouse over a code of Hazard statement or Precautionary statement. Hazard statement and 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. |
Updated date:
|
2017/1/30 Addition of Rationale for the classification |