NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	57520-17-9
Chemical Name	1,1'-(Ammoniumdiyldioctane-8,1-diyl)diguanidinium triacetate; Iminoctadine triacetate
Substance ID	R02-A-041-METI
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
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)
Model SDS by MHLW (External link)
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.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
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.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
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 (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is ionically bonded to an element (N) other than carbon or hydrogen and does not contribute to oxidization.
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
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.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Because LD50 values near the upper limit for Category 3 - Category 4 were obtained in (1) - (4), it was classified in Category 3 by adopting the category with higher hazard. [Evidence Data] (1) LD50 for rats (males): 220 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)) (2) LD50 for rats (females): 187 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)) (3) LD50 for rats (males): 326 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)) (4) LD50 for rats (females): 300 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
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) - (4). [Evidence Data] (1) LD50 for rats (males): > 1,500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)) (2) LD50 for rats (females): 1,400 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)) (3) LD50 for rats: > 826 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)) (4) LD50 for rats: > 826 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
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 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] It was classified in Category 1 from (1). [Evidence Data] (1) LC50 for rats (4 hours): 0.028 mg/L (mist) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, the knowledge in (1) was not used for classification because the constituents of a formulation were unknown. [Reference Data, etc.] (1) It is reported that in a skin irritation test with rabbits, when a 25% formulation of this substance was applied, moderate irritation was seen (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, the knowledge in (1) was not used for classification because the constituents of a formulation were unknown. [Reference Data, etc.] (1) It is reported that in an eye irritation test with rabbits, when a 25% formulation of this substance was applied, corneal opacity, iridial hyperemia, conjunctival redness, etc. were observed from 1 day after administration, and severe reversible irritation to the eye mucosa was seen (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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) in accordance with the GHS classification guidance for the Japanese government. [Evidence Data] (1) A maximization test with guinea pigs gave a negative result (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) It was negative in multiple dominant lethal tests with rats (oral administration) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), Japan Crop Protection Association (1998)). (2) It was negative in a micronucleus test with mouse bone marrow cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), Japan Crop Protection Association (1998)). (3) It was negative in a bacterial DNA repair test and a bacterial reverse mutation test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), Japan Crop Protection Association (1998)). (4) In a mammalian cell chromosomal aberration test, it was weakly positive (S9+) and negative (S9-) in the CHO cells, but it was negative in the CHL cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), Japan Crop Protection Association (1998)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was reported that the incidence of tumors increased in the tests with rats and mice, and based on the results of the risk assessment by the Food Safety Commission of Japan in (3), it was classified in Category 2. [Evidence Data] (1) In a 2-year combined chronic toxicity/carcinogenicity study with rats, a significant increase in the incidence of mononuclear cell leukemia (male) and adrenal pheochromocytoma was observed in the group administered at the maximum dose of 300 ppm (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (2) In a 2-year carcinogenicity study with mice, at the maximum dose of 300 ppm, an increase in the incidence of renal epithelial tumors was observed only in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (3) In a carcinogenicity study, an increase in the incidence frequency of adrenal pheochromocytoma in male and female rats and mononuclear cell leukemia in males, and the incidence of renal epithelial tumors in male and female mice were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (4), it was classified in Category 1B. [Evidence Data] (1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding, at 100 ppm, general toxic effects (degeneration/regeneration of epithelial cells of the vas deferens (male), cell hypertrophy of the distal tubules (female), etc.), and a decrease in fertility index (P and F1 female) were observed in parent animals. The decrease in fertility index was considered to be caused by a decrease in semen attributable to sperm granuloma that was observed in male rats (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (2) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding, at 200 ppm, semen stasis of the vas deferens, lumen dilation, yellow nodule of the epididymis and vas deferens, increases in absolute and relative weight of the spleen, etc. (P and F1 male), weight gain inhibition, a decrease in food consumption, etc. (P and F1 female), a decrease in fertility index, and a decrease in the number of births (P and F1 female) were observed in parent animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), Japan Crop Protection Association (1998)). (3) It was reported that in a developmental toxicity study with rats dosed by gavage, no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), Japan Crop Protection Association (1998)). (4) It was reported that in a developmental toxicity study with rabbits dosed by gavage, no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), Japan Crop Protection Association (1998)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 3 (narcotic effects), and based on (3), it was classified in Category 1 (respiratory organs). [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats, at 181 to 244 mg/kg group (within the range for Category 1), sedation, a decrease in locomotor activity, piloerection, and salivation were observed in males or females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (2) It was reported that in an acute oral toxicity test with mice, a decrease in locomotor activity, ataxic gait, piloerection, a decrease in respiratory rate, gait disturbance, and intermittent convulsion were observed at 200 mg/kg in males and at 288 mg/kg in females (within the range for Category 1), which did not die (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (3) It was reported that in an acute inhalation (mist) exposure test with rats (4 hours), at 0.028 mg/L (within the range for Category 1), abnormalities (bruit, rale, tachypnea) of respiratory patterns, abnormal posture (hunched posture), and lethargy were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (kidney, reproductive organs (male), liver)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) to (5), effects on the liver, kidney, and reproductive organs (male) were observed within the range for Category 1, and it was classified in Category 1 (kidney, reproductive organs (male), liver). [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding, at 25 ppm (1.01 mg/kg/day (male), 0.9 mg/kg/day (female), within the range for Category 1), effects on the kidney (an increase in relative weight, and degeneration/regeneration of tubular epithelium) were observed; at 100 ppm (3.14 mg/kg/day (male), 2.89 mg/kg/day (female), within the range for Category 1), effects on the testis (decreases in absolute and relative weight, atrophy of the testis) were observed; and at 250 ppm (8.34 mg/kg/day (male), 6.9 mg/kg/day (female), within the range for Category 1), effects on the liver (vacuolization of the hepatocytes, an increase in ALT (female)), and an increase in BUN (female) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (2) It was also reported that in two 90-day oral toxicity tests with dogs dosed by feeding, which were carried out as additional tests to confirm (1) above, at 5 to 10 ppm, which was lower than that in (1) (0.19 to 0.38 mg/kg/day, within the range for Category 1), effects on the testis (atrophy of seminiferous tubules, sperm hypoplasia or aspermatogenesis), or effects on the kidney (tubular degeneration/regeneration) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (3) It was reported that in a 1-year chronic toxicity study with dogs dosed by feeding, at 10 ppm (0.41 mg/kg/day (male), 0.4 mg/kg/day (female), within the range for Category 1), atrophy of seminiferous tubules was observed in males; and at 25 ppm (1.01 mg/kg/day (male), 1.03 mg/kg/day (female), within the range for Category 1), degeneration/regeneration of proximal tubular epithelium was observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (4) It was reported that in a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, at or above 100 ppm (3.56 mg/kg/day (male), 4.41 mg/kg/day (female), within the range for Category 1), non-neoplastic lesions were observed in the testis (sperm granuloma of the vas deferens); and at or above 300 ppm (11.3 mg/kg/day (male), 14.2 mg/kg/day (female), within the range for Category 2), interstitial cell hyperplasia of the testis, and effects on the hematology (decreases in RBC/Hb/Ht, an increase in WBC (female only)), the liver (massive hyperplasia of the hepatocytes (male only)), and the kidney (diffuse proximal tubular epithelium degeneration, diffuse distal tubular epithelium swelling, single cell necrosis of the tubular epithelium, cystic renal tubules, interstitial fibrosis, etc.) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (5) It was reported that in a 2-year carcinogenicity study with mice dosed by feeding, at or above 100 ppm (8.55 mg/kg/day (male), 7.94 mg/kg/day (female), within the range for Category 1), swelling of the proximal tubular epithelium of the kidney was observed as a non-neoplastic lesion; and at or above 300 ppm (26 mg/kg/day (male), 29.5 mg/kg/day (female), within the range for Category 2), effects on the hematology (decreases in Hb/Ht), the liver (perilobular and diffuse hypertrophy, an increase in ALP), and the kidney (dilated renal tubules, cyst formation, urinary cast, calcification, interstitial fibrosis, an increase in BUN (female)), etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). [Reference Data, etc.] (6) It was reported that in a 90-day oral toxicity test with rats dosed by feeding, at or above 240 ppm (17.5 mg/kg/day (male), 19 mg/kg/day (female), within the range for Category 2), effects on the liver (hepatocellular degeneration/necrosis), and the kidney (an increase in relative weight, glomerular fibrosis and basement membrane thickening, interstitial connective tissue proliferation, tubular protein cast, and epithelial degeneration), and a decrease in WBC in males were observed; and at 320 ppm (25.4 mg/kg/day (male), 26.7 mg/kg/day (female), within the range for Category 2), a decrease in Hb, and decreases in plasma ChE and TP were observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)). (7) It was reported that in a 90-day oral toxicity test with mice dosed by feeding, at or above 240 ppm (29.6 mg/kg/day (male), 32.5 mg/kg/day (female), within the range for Category 2), effects on the liver (hepatocellular degeneration/necrosis), and the kidney (increases in absolute and relative weight, chronic glomerulonephritis), and a decrease in Hb in females were observed; and at 320 ppm (41.4 mg/kg/day (male), 42.6 mg/kg/day (female), within the range for Category 2), a decrease in Ht was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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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