GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 3383-96-8
Chemical Name Temephos
Substance ID R01-B-054
Classification year (FY) FY2019
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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) MHLW Website (in Japanese Only)
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 *
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2 Flammable gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3 Aerosols *
-
-
- - Not aerosol products. It was classified as "Not classified (Not applicable)."
4 Oxidizing gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5 Gases under pressure *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6 Flammable liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7 Flammable solids *
-
-
- - There is information that it is combustible (ICSC (2007)), but the classification is not possible due to no data.
8 Self-reactive substances and mixtures *
-
-
- - There is a P-O bond, a chemical group associated with self-reactive properties, present in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10 Pyrophoric solids *
-
-
- - It was classified as "Not classified" because it is classified in Division 6.1 in UNRTDG (UN2783), and it was considered to be not applicable to pyrophoric solids, hazards of the highest precedence.
11 Self-heating substances and mixtures *
-
-
- - Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases *
-
-
- - It contains a metalloid (P), but It was classified as "Not classified" because it is estimated that it does not react vigorously with from data: it is insoluble in water (ICSC (2007)).
13 Oxidizing liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14 Oxidizing solids *
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to an element (P) other than carbon or hydrogen. However, the classification is not possible due to no data.
15 Organic peroxides *
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16 Corrosive to metals *
-
-
- - It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
17 Desensitized explosives *
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) *
-
-
- - [Rationale for the Classification]
Based on (1)-(3), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats: 4,000-13,000 mg/kg (JMPR (2006))
(2) LD50 for rats: male: 8,000 mg/kg, female: 13,000 mg/kg (ACGIH (7th, 2019))
(3) LD50 for rats: male: 8,600 mg/kg, female: 13,000 mg/kg (HSDB (Access on July 2019))

[Reference Data, etc.]
(4) LD50 for rats: 1,226-13,000 mg/kg (PATTY (6th, 2012))
(5) LD50 for rats: 444-2,000 mg/kg (ACGIH (7th, 2019))
(6) LD50 for rats: 444 mg/kg (EPA Pesticide (2000), HSDB (Access on July 2019))
(7) LD50 for rats: 1,000 mg/kg (HSDB (Access on July 2019))
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
[Rationale for the Classification]
From (1)-(7), based on findings of rabbits, it was classified in Category 3.
The category was changed from the previous classification by the use of new information sources.

[Evidence Data]
(1) LD50 for rabbits: 970-1,850 mg/kg (PATTY (6th, 2012))
(2) LD50 for rabbits: male: 1,850 mg/kg, female: 970 mg/kg (ACGIH (7th, 2019), EPA Pesticide (2000))
(3) LD50 for rabbits: male: 1,930 mg/kg, female: 970 mg/kg (HSDB (Access on July 2019))
(4) LD50 for rabbits: 970 mg/kg (HSDB (Access on July 2019))
(5) LD50 for rats: >4,000 mg/kg (PATTY (6th, 2012), ACGIH (7th, 2019), HSDB (Access on July 2019))
(6) LD50 for rats: 2,000 to > 4,000 mg/kg (JMPR (2006))
(7) LD50 for rats: 1,370 mg/kg (HSDB (Access on July 2019))
1 Acute toxicity (Inhalation: Gases) *
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1 Acute toxicity (Inhalation: Vapours) *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) *
-
-
- - [Rationale for the Classification]
Based on (1), because it was impossible to identify the category, it was classified as "Classification not possible."
Besides, since the LC50 values were higher than the saturated vapor concentration (0.000002 mg/L), the reference value in units of mg/L was applied as the dust.

[Evidence Data]
(1) LC50 for rats (4 hours): >1,300 mg/m3 (1.3 mg/L) (PATTY (6th, 2012), ACGIH (7th, 2019), HSDB (Access on July 2019)).

[Reference Data, etc.]
(2) LC50 for rats (exposure time unknown): >4.79 mg/L (JMPR (2006)).
2 Skin corrosion/irritation *
-
-
- - [Rationale for the Classification]
Based on (1)-(3), it was classified as "Not classified."

[Evidence Data]
(1) In a skin irritation test with rabbits according to EPA OPPTS 870.2500, no irritating effects were observed (primary irritation score 1.4) (EPA Pesticide (2000), HSDB (Access on July 2019)).
(2) This substance was not an irritant to the eyes and skin of rabbits (JMPR (2006)).
(3) This substance was slightly irritating to the skin and eyes. However, it was not a skin sensitizer (PATTY (6th, 2012)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 2B.

[Evidence Data]
(1) In an eye irritation test with rabbits according to EPA OPPTS 870.2400, slight irritation was observed (EPA Pesticide (2000), HSDB (Access on July 2019)).
(2) This substance was slightly irritating to the skin and eyes. However, it was not a skin sensitizer (PATTY (6th, 2012)).

[Reference Data, etc.]
(3) This substance was not irritating to the eyes and the skin of rabbits (JMPR (2006)).
4 Respiratory sensitization *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization *
-
-
- - [Rationale for the Classification]
Based on (1)-(3), it was classified as "Not classified."

[Evidence Data]
(1) This substance was slightly irritating to the eyes but not irritating and sensitizing to the skin (EPA Pesticide (2000), HSDB (Access on July 2019)).
(2) In a skin sensitization test (Buehler method) with guinea pigs, this substance was not sensitizing to the skin (JMPR (2006)).
(3) This substance was slightly irritating to the skin and eyes, however, it was not a skin sensitizer (PATTY (6th, 2012)).
5 Germ cell mutagenicity *
-
-
- - [Rationale for the Classification]
There was no in vivo data, therefore, classification was not possible due to lack of data.

[Evidence Data]
(1) As for in vitro, negative results were reported in a bacterial reverse mutation test, and a chromosome aberration test and an unscheduled DNA synthesis test with cultured mammalian cells (PATTY (6th, 2012)).
6 Carcinogenicity *
-
-
- - [Rationale for the Classification]
Based on the classification results by other organizations in (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) As the classification results by domestic and international organizations, it was classified as A4 by ACGIH (ACGIH (7th, 2019)).
7 Reproductive toxicity *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) In a three-generation reproductive toxicity test with rats by feeding, no reproductive and developmental effects were observed (ACGIH (7th, 2019), PATTY (6th, 2012)).
(2) In a developmental toxicity test with rabbits by oral or dermal administration, reduced body weight gain was seen in maternal animals by dermal application. No developmental toxicity was observed, however, in either administration route (ACGIH (7th, 2019), PATTY (6th, 2012)).

[Reference Data, etc.]
(3) In an oral administration test at one dose throughout mating, gestation, parturition and lactation, no effects on the number of litters, litter size, viability of young, or incidence of malformations were observed. However, inhibition of RBC cholinesterase activity in dams and 21-day-old pups (90% decrease in dams and 30% decrease in pups) was observed (ACGIH (7th, 2019), PATTY (6th, 2012))
8 Specific target organ toxicity - Single exposure Category 2 (nervous system)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
[Rationale for the Classification]
There was no information on single exposure in humans. Based on (1)-(3), it was classified in Category 2 (nervous system).

[Evidence Data]
(1) This substance is an organophosphorus pesticide and affects the nervous system due to inhibition of cholinesterase (ACGIH (7th, 2019), IPCS, PIM G001 (1986)).
(2) In oral exposure tests with rats and mice, this substance caused typical signs of organophosphate poisoning with single doses as low as 500 mg/kg (corresponding to Category 2) (ACGIH (7th, 2019), PATTY (6th, 2012)).
(3) Signs of toxicity observed in animals treated with high doses of this substance are typical of acute toxicity signs induced by cholinesterase inhibition such as hypoactivity, labored breathing, rough coat, chromodacryorrhea, salivation, muscle spasms and tremors (EPA Pesticide (2000)).

[Reference Data, etc.]
(4) This substance might cause cholinesterase inhibition in humans, affecting the nervous system to result in nausea, dizziness and confusion. A large amount of exposure (accidents or leakages) may cause respiratory distress and result in death (HSDB (Access on July 2019)).
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system)


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1)-(3), in oral dose tests with experimental animals, cholinesterase activity inhibition was observed in erythrocytes at doses within the range for Category 1 and in the brain at doses within the range for Category 2. Therefore, it was classified in Category 1 (nervous system).

[Evidence Data]
(1) In a 90-day feeding test with rats at 2-350 ppm, inhibition of erythrocyte cholinesterase activity was observed at or above 18 ppm (0.9 mg/kg/day, within the range for Category 1) (ACGIH (7th, 2019)).
(2) In a 129-day feeding test with dogs at 10, 50 ppm, inhibition of erythrocyte cholinesterase activity was observed at 50 ppm (3-4 mg/kg/day, within the range for Category 1) (ACGIH (7th, 2019), JMPR (2006)).
(3) In a 2-year feeding test with dogs, cholinergic symptoms, inhibition of erythrocyte cholinesterase activity and inhibition of brain cholinesterase activity were observed at 12.5 mg/kg/day (within the range for Category 2) (JMPR (2006)).

[Reference Data, etc.]
(4) In humans, repeated oral doses of up to 3.7 mg/kg were without cholinergic effects (ACGIH (7th, 2019)).
(5) In humans exposed to this substance at 1.1 mg/kg/day for 4 weeks, or at 4.27 mg/kg/day for 5 days, there was no inhibition of cholinesterase activity in erythrocytes or plasma (JMPR (2006)).
10 Aspiration hazard *
-
-
- - [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) Category 1


Warning
H400 P273
P391
P501
it was classified in Category 1 from 48-hour EC50 = 0.00054 mg/L for crustacea (Daphnia magna) (U.S.EPA: OPP Pesticide Ecotoxicity Database, 2019).
11 Hazardous to the aquatic environment Long term (Chronic) Category 1


Warning
H410 P273
P391
P501
Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (BIOWIN), and it was classified in Category 1 in acute toxicity.
12 Hazardous to the ozone layer Classification not possible
-
-
- - Classification not possible due to lack of data.


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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