GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 39148-24-8
Chemical Name Aluminium triethyl triphosphonate; Fosetyl-aluminum
Substance ID R02-A-079-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
-
-
- - It contains a metal (Al) and metalloids (P), but it is estimated that it does not react vigorously with water from measured data: water solubility of 111 g/L (20 deg C) (Ministry of the Environment (2017)).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
14 Oxidizing solids Classification not possible
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to elements other than carbon or hydrogen (Al, P). However, the classification is not possible due to no data.
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
-
-
- - 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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (9).

[Evidence Data]
(1) LD50 for rats (males): 11,300 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(2) LD50 for rats (females): 10,600 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(3) LD50 for rats (males): about 6,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(4) LD50 for rats (females): about 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(5) LD50 for rats (males): about 9,500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(6) LD50 for rats (females): about 8,200 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(7) LD50 for rats: > 7,080 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(8) LD50 for rats: > 2,000 mg/kg (JMPR (2017))
(9) LD50 for rats: 5,400 mg/kg (EPA Pesticides RED (1990))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (4).

[Evidence Data]
(1) LD50 for rats: > 3,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(2) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(3) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), JMPR (2017))
(4) LD50 for rabbits: > 2,000 mg/kg (EPA Pesticides RED (1990))
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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1). Besides, the exposure time was judged as 4 hours in (1) because it is toxicity information described in the Risk Assessment Report (Pesticides) (Food Safety Commission of Japan).

[Evidence Data]
(1) LC50 for rats (dust): > 5.11 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), JMPR (2017))

[Reference Data, etc.]
(2) LC50 for rats (dust): > 1.67 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016))
(3) LC50 for rats: > 1.73 mg/L (EPA Pesticides RED (1990))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 6) (7-day observation), no irritation changes were observed after applying to the intact skin and abraded skin (EPA Pesticides RED (1990), Agchem Age No. 159 (Japan Crop Protection Association, 1989)).
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
[Rationale for the Classification]
It was classified in Category 1 from (1), (2).

[Evidence Data]
(1) It is reported that in an eye irritation test with rabbits, moderate to severe irritation was observed (JMPR Report (2017)).
(2) It is reported that in an eye irritation test with rabbits (OECD TG 405, GLP), severe irritation was seen (JMPS (2013)).
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) - (3).

[Evidence Data]
(1) It was negative for sensitization in a maximization test with guinea pigs (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
(2) It was negative in a maximization test with guinea pigs (JMPR (2017)).
(3) This substance is not a skin sensitizer (EFSA (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) In a micronucleus test using mice (single oral dose), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), EFSA (2019)).
(2) In a bacterial reverse mutation test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), EFSA (2019)).
(3) In a gene mutation test using the mouse lymphoma cells, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), EFSA (2019)).
(4) It was reported that in a chromosomal aberration test using the Chinese hamster ovary cells (CHO), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), EFSA (2019)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified." According to the GHS Classification Guidance for the Japanese Government, it was considered that the mechanism of formation of tumors due to physical irritation to the bladder mucosa by uroliths in (3) could deny that this substance was carcinogenic in humans.

[Evidence Data]
(1) As for the classification results by domestic and international organizations, EPA classified this substance in NL (Not Likely to be Carcinogenic to Humans) (EPA Annual Cancer Report (2019)).
(2) In two-year carcinogenicity studies with rats and mice dosed by feeding, increased tumorigenesis in the urinary bladder transitional epithelium was observed in male rats at the highest dose of 30,000 ppm (1,370/1,790 mg/kg/day), while no evidence of carcinogenicity was observed in mice dosed at up to 30,000 ppm (3,960/4,550 mg/kg/day) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), JMPR (2017), EFSA (2019)).
(3) In a study of the mechanism of tumorigenesis in the urinary bladder in rats, it was considered that at massive doses of this substance (> 1,000 mg/kg/day), uroliths were formed due to precipitation of calcium phosphate in the urine, and these uroliths caused sustained irritation, inflammation, and cytotoxicity to the urothelium due to a long-term repeated exposure, resulting in hyperplasia of the bladder and kidney inducing tumorigenesis in the transitional epithelium. It was concluded that humans could not be exposed to such high doses approaching the solubility limit that would cause precipitation of calcium phosphate (JMPR (2017), EFSA (2019)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified."

[Evidence Data]
(1) It was reported that in a three-generation reproduction toxicity study with rats dosed by feeding, at 12,000 ppm, lower body weight in parental animals and reduced body weight gain of live pups, and histopathological changes in the urinary bladder in F3 pups were observed, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), JMPR (2017), EFSA (2019)).
(2) It was reported that in a developmental toxicity study with rats dosed by gavage (days 6-15 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), JMPR (2017)).
(3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (days 4-28 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), JMPR (2017)).
(4) It was reported that in a developmental toxicity study with rabbits dosed by gavage (days 6-16 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
8 Specific target organ toxicity - Single exposure Category 3 (respiratory tract irritation, narcotic effects)


Warning
H335
H336
P304+P340
P403+P233
P261
P271
P312
P405
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 3 (respiratory tract irritation, narcotic effects).

[Evidence Data]
(1) It was reported that in an acute inhalation (dust) toxicity test with rats, licking the inside of the mouth, nictitation, dyspnea, gasping and shortness of breath were observed at 1.67 mg/L (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, (2016)).
(2) It was reported that in an acute inhalation (dust) toxicity test with rats, moist fur, labored breathing and reduced respiratory rate, stooping posture, piloerection, wheezing, ptosis, tiptoeing, and lethargy were observed at 5.11 mg/L (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs)


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1), the target organs were considered to be the respiratory organs, and effects were observed within the dosage range for Category 1, therefore, it was classified in Category 1 (respiratory organs). The effects in the urinary organ observed in (2) and (3) were excluded because based on (4), they were attributed to the production of calculii due to precipitation of calcium phosphate in the urine and would not be caused in humans.

[Evidence Data]
(1) It was reported that in a 21-day repeated inhalation (dust) toxicity test with rats (6 hours/day, 4 or 5 days/week), histopathological changes in the respiratory organs such as hyperplasia of the larynx, thickening of the alveolus, and changes in the bronchiolar epithelium/interstitium were observed at or above 10 mg/m3 (converted guidance value: 0.0013 mg/L or 0.0017 mg/L, within the range for Category 1); and effects on the bone marrow (megakaryocyte pyknosis) and effects on the urinary bladder (hyperplasia of the transitional epithelium) were observed at 1,000 mg/m3 (converted guidance value: 0.13 mg/L or 0.17 mg/L, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
(2) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by feeding, at 30,000 ppm (2,340 mg/kg/day (males), 2,630 mg/kg/day (females), in the range corresponding to "Not classified"), aciduria was observed; and occult blood, renal and vesical calculi, lymphocytic infiltration in the renal interstitium, cystiform dilatation of the renal pelvis, hyperplasia of transitional epithelium of the renal calyx, hyaline droplets in the proximal tubular epithelium, and hyperplasia of the urinary bladder transitional epithelium were observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, (2016)).
(3) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, renal cyst and bladder inflammation (males) were observed at 8,000 ppm (348 mg/kg/day (males), 450 mg/kg/day (females), in the range corresponding to "Not classified"); and vesical calculi, calcinosis, hydronephrosis, spongiform degeneration of the brain, inflammation of the testes, inflammation of the seminal vesicles, and hyperplasia of the urinary bladder transitional epithelium were observed in males at 30,000 ppm (1,370 mg/kg/day (males), 1,790 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), JMPR (2017)).
(4) In a study of the mechanism of tumorigenesis in the urinary bladder in rats, it was considered that at massive doses of this substance (> 1,000 mg/kg/day), uroliths were formed due to precipitation of calcium phosphate in the urine, and these uroliths caused sustained irritation, inflammation and cytotoxicity to the urothelium due to a long-term repeated exposure, resulting in hyperplasia of the bladder and kidney inducing tumorigenesis in the transitional epithelium. It was concluded that humans could not be exposed to such high doses approaching the solubility limit that would cause precipitation of calcium phosphate (JMPR (2017), EFSA (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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