NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	23422-53-9
Chemical Name	Formetanate hydrochloride
Substance ID	m-nite-23422-53-9_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gas	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solid	Not classified	- -	-	-	It was classified as "Not classified" from the information that it is "not flammable" (PM (14th, 2006)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 2	Danger	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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 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)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
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)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 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))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+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))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (nervous system)	Warning	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).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour EC50 = 0.0868 mg/L for crustacea (Daphnia magna) (AQUIRE, 2012).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	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.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

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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