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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	333-41-5
Chemical Name	Diazinon
Substance ID	H28-B-023, C-034B
Classification year (FY)	FY2016
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)	MHLW Website (in Japanese Only)
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	Not applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	Based on a flash point of > 100 deg C (GESTIS (Access on May 2016)), it was classified as "Not classified."
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 400 deg C (HSFS (Access on May 2016)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It is estimated that it does not react vigorously with water due to the water solubility data measured (0.06 g/L (ICSC (2004))).
13	Oxidizing liquids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen which is chemically bonded to the element other than carbon or hydrogen, but the classification is not possible due to no data.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	As for LD50 values for rats, there were one report (300 mg/kg) corresponding to Category 3, 9 reports (422 mg/kg - 1,350 mg/kg) corresponding to Category 4, and one report (> 2,150 mg/kg) corresponding to "Not classified" (JMPR (2006), Risk Assessment Report (Pesticides and Veterinary Medical Products) (Food Safety Commission of Japan, 2014)). From the above, this substance was classified in Category 4 to which more reports correspond.
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	LD50 values for rats were reported as 876 mg/kg, 1440 mg/kg and 1670 mg/kg (Risk Assessment Report (Pesticides and Veterinary Medical Products) (Food Safety Commission of Japan, 2014)). From the above, since there were one and two reports corresponding to Category 3 and Category 4, respectively, this substance was classified in Category 4 to which the larger number of reports correspond.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	As for LC50 values for rats, there was one report of 3.10 mg/L (4 hours) (OEL Documentations (Japan Society For Occupational Health (JSOH), 1989)), three reports of 3,500 mg/m3 (3.50 mg/L) (4 hours) (ACGIH (7th, 2003), Environmental Risk Assessment for Chemical Substances Volume 4 (Ministry of the Environment, 2005), PATTY (6th, 2012)), and two reports of > 5.44 mg/L (4 hours) (HSDB (Access on May 2016)). Since there are four reports corresponding to Category 4 and two reports corresponding to ''Not classified,'' this substance was classified as Category 4 to which the larger number of relevant reports correspond. Besides, since this value is higher than the saturated vapor pressure concentration (0.001mg/L), the reference value of mist was applied.
2	Skin corrosion/irritation	Not classified	- -	-	-	This substance was classified as ''Not classified'' (Category 3 in UN GHS classification) based on a report that in a skin irritation test using rabbits, it showed slight irritation (EHC 198 (1998)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	This substance was classified as ''Not classified'' based on a report that slight irritation was observed in an eye irritation test using rabbits (EHC 198 (1998)). The information source used for classification was changed along with the revision of information sources.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	It is reported that a Buehler test using guinea pigs was negative (EPA pesticide (2006), ACGIH (7th, 2003)) and it is described that this substance was not a sensitizer (PATTY (6th, 2012), while it is reported that in a skin sensitization test (maximization test) using guinea pigs, skin sensitization was positive (Risk Assessment Report (Pesticides and Veterinary Medical Products) (Food Safety Commission of Japan, 2014)). Also in individual literature (Contact Derm. 54 (2006)), there was a case of allergic contact dermatitis in humans, and the substance was reported as positive (grade III) in a skin sensitization test (maximization method) using guinea pigs. Therefore, this substance was classified in Category 1.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, there were positive results in micronucleus tests using rat peripheral blood and mouse bone marrow cells and in DNA damage tests using rabbit liver or kidney, and negative results in a mouse dominant lethal test and chromosome aberration tests using mouse spermatogonia and spermatocyte, in a micronucleus test and a sister chromatid exchange test using mouse bone marrow cells (EHC 198 (1998), IARC 112 (2015)). As the recent information, it is evaluated in JMPR (2016) that the substance is unlikely to be genotoxic. In vivo findings at EHC 198 (1998) are all negative results. However, the positive results of the in vivo micronucleus tests and DNA damage tests reported in IARC 112 (2015) also contain findings of low purity (formulation). As for in vitro, there were positive and negative results in bacterial reverse mutation tests, mouse lymphoma tests, sister chromatid exchange tests, micronucleus tests, and chromosome aberration tests using cultured mammalian cells (EHC 198 (1998), ACGIH (7th, 2003), ATSDR (2008), PATTY (6th, 2012), JMPR (1993), IARC 112 (2015), NTP DB (Access on June 2106)). From the above, although the in vivo findings conflicted with each other, the latest information from JMPR (2016) was adopted and this substance was classified as "Classification not possible."
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	IARC concluded that there is limited evidence in humans for carcinogenicity since in humans a positive association has been observed between exposure to the substance and non-Hodgkin's lymphoma, leukemia, and cancer of the lungs (IARC 112 (2015)). On the other hand, in experimental animals, there was an increase in the incidence of leukemia and lymphoma (combined) only in males (no dose relationship) in one of two studies in rats administered by feeding, and there was an increase in the incidence of hepatocellular carcinoma in males in the low dose group in a feeding study using mice (IARC 112 (2015)). IARC's working group concluded that because both findings are in males only and there is a lack of dose relationship, they are not clearly related to the test compound administered, and evidence of carcinogenicity in laboratory animals is limited. However, there is strong evidence that this substance can operate as a human carcinogen in terms of its mechanisms of action. Based on limited evidence of carcinogenicity in humans and experimental animals and strong mechanistic evidence, IARC has classified this substance in Group 2A for carcinogenicity classification (IARC 112 (2015)). Based on the latest evaluation from IARC, this substance was classified in Category 1B for this hazard class. Though previous classifications by other organizations include NL by the EPA (EPA Chemicals Evaluated for Carcinogenic Potential (2006)) and A4 by ACGIH (ACGIH (7th, 2003)), the classification of IARC and new classifications were prioritized according to the GHS Classification Guidance for the Japanese Government. Additionally, with regard to carcinogenicity in experimental animals, JMPR concluded that no carcinogenicity is observed in rats and mice (JMPR (2016)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a two-generation reproduction toxicity study in rats administered by feeding, the parent animals showed decreased weight gain at 100 ppm or above and decreases in the copulation index and fertility index, tremors and prolonged gestation periods at 500 ppm; pups suffered death and decreased weight gain at 100 ppm or above and decreases in the number of litters and live pups at 500 ppm (Risk Assessment Report (Pesticides and Veterinary Medical Products) (Food Safety Commission of Japan, 2014)). In addition, oral administration to male rats for 65 days resulted in decreased reproductive tissue weights, increased percentage of morphologically abnormal spermatozoa, decreased plasma testosterone levels, and decreased fertility index in mating of dosed males with untreated females (ATSDR (2008). It is described that oral administration to male dogs for 8 months resulted in testicular atrophy and completely arrested spermatogenesis (ATSDR (2008), ACGIH (7th, 2003)). On the other hand, in teratogenicity studies where pregnant rats (2 studies) or pregnant rabbits (2 studies) dosed orally during the organogenesis period, in rats, only delayed ossification or skeletal variation was observed in the fetuses with or without maternal toxicity. In rabbits, one study showed lower body weight below the level of maternal toxicity, but in the other study there was no toxic effect on the fetuses even at the dose with significant maternal toxicity, and teratogenicity was not observed. The effects of developmental toxicity were so marginal that they did not serve as grounds for classification (Risk Assessment Report (Pesticides and Veterinary Medical Products) (Food Safety Commission of Japan, 2014)). From the above, in addition to the effects on fertility (decrease in copulation index and fertility index) in the level of general toxicity in parental animals, effects on the testicular function of male animals were reported. Therefore, this substance was classified in Category 2 for this hazard class.
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance is a cholinesterase inhibitor. It is reported that humans who ingested this substance orally by accident or by intention revealed nausea, vomiting, abdominal pain, headache, miosis, tachycardia, profuse diaphoresis, sialorrhea, ataxia, and twitching. In addition, symptoms of headache, blurred vision, dizziness, fatigue, nausea, and vomiting due to inhalation exposure after spraying of an insecticide containing the substance have been reported (ACGIH (7th, 2003)). Furthermore, it was reported that, in a single oral exposure study using rats, decreased activity, ataxia, and tremors were observed, and in a single inhalation exposure test, decreased activity and increased salivation were noted at doses within the range of guidance values for Category 1(ACGIH (7th, 2003)). From the above, this substance was classified in Category 1 (nervous system).
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system), Category 2 (liver, kidney, haemal system, genetic organs (men))	Danger Warning	H372 H373	P260 P264 P270 P314 P501	There was no information for humans. As for experimental animals, in a 90-day repeated dose toxicity study using dogs administered by gavage, inhibition of erythrocyte and brain acetylcholinesterase activity were shown at not less than 3 mg/kg/day, which is within the range of Category 1, effects on blood (decrease in erythrocyte count, hemoglobin concentration hematocrit), on the liver (periportal inflammatory cell infiltration, increases in AST, ALT, alkaline phosphatase and GGT activity in males, and hyperplasia of the bile duct in females), and on the kidneys (fatty degeneration of the proximal tubules in males, regeneration of tubular epithelium in females) were seen at 10 mg/kg/day, which is within the range of Category 2. In an 8-month chronic study using dogs administered by gavage, cholinergic findings such as death, vomiting, diarrhea and twitching and increased myelocytes, cirrhosis, focal necrosis of the liver, atrophy of the testes, inhibition of spermatogenesis, atrophy of the kidneys, nephritis with tubular and glomerular degeneration were observed in the 10 or 20mg/kg/day dose groups, which are within the range of Category 2. In studies using rats administered by feeding, effects on the nervous system (inhibition of erythrocytes or brain acetylcholinesterase activity by 20% or more) were noted at the dose in the range of Category 1 (Risk Assessment Report (Pesticides and Veterinary Medical Products) (Food Safety Commission of Japan, 2014)). In the dermal route, a 21-day dermal toxicity study using rabbits dosed at 100 or 50 mg/kg/day (dosed at 100 mg kg/day initially, and at 50 mg/kg/day for the last 7 days due to death; converted guidance value: 22.3 or 11.7 mg/kg /day), which is largely within the range of Category 1, showed inhibition of erythrocytes and brain acetylcholinesterase activity by 20% or more (Risk Assessment Report (Pesticides and Veterinary Medical Products) (Food Safety Commission of Japan, 2014)). Therefore, this substance was classified in Category 1 (nervous system) and Category 2 (liver, kidneys, haemal system, genetic organs (men)). In addition, since the inhibition of the activity of the erythrocytes and brain acetylcholinesterase (not less than 20%) was taken as an influence on the nervous system, the classification was changed.
10	Aspiration hazard	Classification not possible	- -	-	-	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 (Acute)	Category 1	Warning	H400	P273 P391 P501	From EC50 (unknown time) = 0.20 ppb for crustacea (Gammarus) (U.S. EPA: RED, 2006), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	Due to not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1979), and 21-day NOEC = 0.17 ppb for crustacea (Daphnia magna) (U.S.EPA: RED, 2006), it was classified in Category 1.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

NOTE:

* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_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.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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