GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 121-75-5
Chemical Name O,O-Dimethyl-S-1,2-bis(ethoxycarbonyl)ethyl dithiophosphate [Malathion]
Substance ID H28-B-026, C-037B
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
-
-
- -  A flash point is 163 deg C (closed cup) (HSDB (Access on June 2016)).
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 Classification not possible
-
-
- -  No data available.
10 Pyrophoric solids Not applicable
-
-
- -  Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- -  Test methods applicable to liquid substances are not available.
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 result measured (145 mg/L (20 deg C) (HSDB (Access on June 2016)).
13 Oxidizing liquids Classification not possible
-
-
- -  The substance is an organic compound containing oxygen, 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
-
-
- -  There is the information that it attacks metals including iron (HSDB (Access on June 2016)), but the classification is not possible due to no data.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- -  There were the following 10 reports as LD50 values for rats: 1,390 mg/kg (males), 1,450 mg/kg (female) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)), 1,580 mg/kg (male and female) (JMPR (1997)), 4,061 mg/kg (female) (JMPR (1997)), 5,400 mg/kg (male), 5,700 mg/kg (female) (EPA RED (2009), JMPR (1997)), 6,156 mg/kg (males), 8,000 mg/kg (male and female), 8,210 mg/kg (males), and 8,239 mg/kg (female) (JMPR (1997)). Since 3 cases correspond to Category 4 and 7 cases correspond to "Not classified," this substance was classified as "Not classified," under which the greatest number of cases fall. Following the revision of the GHS Classification Guidance for the Japanese Government, the category was revised.
 For this substance, based on expert judgment, the LD50 values of the JMPR, the Food Safety Commission of Japan, and the EPA were preferentially adopted as information sources.
1 Acute toxicity (Dermal) Not classified
-
-
- -  Based on the four reported LD50 values for rats of > 2,000 mg/kg (gender unknown) (JMPR (1997)), > 2,000 mg/kg (males and females) (EPA RED (2009)), > 5,000 mg/kg (males and females) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)), and > 44,444 mg/kg (males and females) (JMPR (1997)), this substance was classified as "Not classified."
 For this substance, based on expert judgment, the LD50 values of the JMPR, the Food Safety Commission of Japan, and the EPA were preferentially adopted as information sources.
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) Not classified
-
-
- -  Based on the report of > 5.2 mg/L (males and females) (JMPR (1997)) as an LC50 value (4 hours) for rats, this substance was classified as "Not classified." Note that since this value is higher than the saturated vapor pressure concentration (0.0045 ppm (0.0603 microg/L)), the reference value of mist was applied. The category was revised along with the revision of the GHS Classification Guidance for the Japanese Government.
 Additionally, for this substance, based on expert judgment, the LD50 value of JMPR was preferentially adopted as the information source.
2 Skin corrosion/irritation Not classified
-
-
- -  Based on the report that as a result of a skin irritation test on rabbits, very slight erythema and edema were observed and the skins were all normal after 2 days (JMPR (1997), EPA RED (2006, 2009), ACGIH (7th, 2003), PATTY (6th, 2012)), this substance was classified as "Not classified" (Category 3 of the UN GHS classification standard).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
 In an eye irritation test in rabbits, very slight to slight irritation was observed in the conjunctiva, but resolved after 2 days, and there are no changes in the cornea and iris (JMPR (1997), EPA RED (2006, 2009), ACGIH (7th, 2003), PATTY (6th, 2012)). Based on this report, this substance was classified in Category 2B. The category was changed in accordance with the GHS Classification Guidance for the Japanese Government.
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
 In skin sensitization tests using guinea pigs, there are reports that skin sensitization was not observed (JMPR (1997), EPA RED (2006, 2009), ACGIH (7th, 2003), PATTY (6th, 2012)) and reports that it was recognized (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). However, from the description that allergic contact sensitivity has been reported in humans exposed to this substance (IPCS, PIM 001 (1989)), it was classified in Category 1.
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
 As for in vivo, findings have been negative in mouse dominant lethal tests; positive and negative in chromosomal aberration tests using mouse spermatogonia or spermatocytes; positive or negative in micronucleus tests using mouse bone marrow cells; positive or negative in chromosomal aberration tests using bone marrow or spleen cells of mice, bone marrow cells of rats, and bone marrow cells of Syrian hamsters; positive in sister chromatid exchanges tests using mouse bone marrow cells or spleen cells; positive in comet assays using rat liver, kidney etc.; and negative in an unscheduled DNA synthesis test using rat liver (JMPR (1997), IARC 112 (2015), ATSDR (2003)). However, the positive findings in the chromosomal aberration tests using mouse spermatogonia and spermatocytes are not clear findings from the weight of evidence with negative findings in the dominant lethal test and chromosomal aberration test using spermatogenic cells. As for in vitro, results were negative in many bacterial reverse mutation tests, positive in a genetic mutation test using cultured mammalian cells or mouse lymphoma test, and many results were positive in a micronucleus test, in chromosomal aberration tests, and in sister chromatid exchange tests (JMPR (1997), ATSDR (2003), IARC 112 (2015)). From the above, according to the GHS Classification Guidance for the Japanese Government, this substance was classified in Category 2.
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
 According to the latest evaluation by IARC, there is a positive correlation between exposure to this substance and non-Hodgkin's lymphoma and prostate cancer in humans and there is limited evidence of carcinogenicity in humans (IARC 112 (2015)). In experimental animals, in two carcinogenicity studies in mice dosed by feeding, increases in hepatocellular adenomas and the combined incidence of hepatocellular adenoma and carcinoma (increases were in males only in one study and in both sexes in the other one) were observed. Similarly, an increase in the incidence of liver tumors was observed in females in one study with rats dosed by feeding. In addition, there was also a report on increases in adrenal gland pheochromocytoma and mammary gland tumor in a rat carcinogenicity study. IARC concluded that there was sufficient evidence of carcinogenicity by exposure to this substance in experimental animals (IARC 112 (2015)). From the above, IARC classified the carcinogenicity of this substance into Group 2A (IARC 112 (2015)). As for classifications by other organizations, there is a background in which this substance was classified by ACGIH in A4 in first (ACGIH (7th, 2003)) and by the EPA in S (suggestive evidence of carcinogenicity: corresponding to Category 2) (EPA RED (2009)). Based on the latest evaluation by IARC, this substance was classified in Category 1B for this hazard class.
7 Reproductive toxicity Not classified
-
-
- -  In an epidemiological study investigating the effect of spraying this substance with pregnant women, there is a description that no association was found between exposure to this substance and spontaneous abortion, intrauterine growth retardation, stillbirth or congenital anomalies (ACGIH (7th, 2003)).
 As for experimental animals, in a 2-generation breeding toxicity study using rats dosed by diet, there were no effects on the parental generation, and only a slight effect (low body weight at weaning) was observed in F1 and F2 pups (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). In addition, in a rat 3-generation breeding toxicity study (dietary administration), general toxicity such as dyspnea, death and low body weight at mating and decreased fertility and delivery indices were observed in the high dose group of F0 parental animals. However, only a slight effect (low body weight at weaning) was seen in F1 pups; in the F1 and in the F2 generations, too, the pups tended to be less affected than the parent animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). On the other hand, in developmental toxicity studies using pregnant rats or pregnant rabbits (by gavage, rats: gestational Days 6 to 15, rabbits: gestational Days 6 to 18), no findings of fetal toxicity were seen even at doses at which decreases in body-weight gain were observed as maternal toxicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2003)). Furthermore, in a developmental neurotoxicity study where pregnant rats were dosed by gavage from day 6 of gestation until Postnatal day 10 and their offspring on Postnatal days 11-21, there were no effects on the dams. Tremors and underactivity were seen in offspring on Postnatal days 11-21, and delay in surface righting reflex was observed on Postnatal day 11. However, it was concluded that these are due to direct action on the offspring and there is no developmental neurotoxicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2003)). Based on the above findings, this substance was classified as "Not classified" 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
 Cases of poisoning by this substance in humans are mainly due to suicide attempts or accidental ingestion. As its symptoms, headaches, lacrimation, salivation, perspiration, tachycardia, dyspnea, vomiting and convulsions, clouding of consciousness, and systemic fibrotic contractions have been reported (OEL Documentations (Japan Society For Occupational Health (JSOH), 1989), ACGIH (7th, 2001)). As for experimental animals, in acute toxicity studies with oral exposure using mice, at doses within the guidance value range of Category 2, symptoms such as decreased alertness, passive hyperresponsiveness, prone position, abnormality of limb posture, salivation, suppressed tactile response, suppressed righting reflex, diarrhea, hypothermia, reduced response (amount of activity) and decreased spontaneous locomotor activity, positional vision abnormality, suppressed pain response, tremors, convulsions, lowered body tone, flaccidity of the limbs, decreased grip strength, suppressed pinna and corneal reflexes, cyanosis and decreased respiratory rate have been reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). From the above, this substance was classified in Category 1 (nervous system).
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system)


Danger
H372 P260
P264
P270
P314
P501
 With regard to humans, it was reported that no apparent clinical signs and cholinergic signs were found in an experimental study in which five men were orally given 8, 16, 24 mg/day (0.11, 0.23, 0.34 mg/kg/day) of this substance for 32, 47, and 56 days. However, it was reported that both plasma and erythrocyte cholinesterase activities were inhibited by about 20% of pre-exposure baseline levels in the 24 mg/day group (ACGIH (7th, 2003)).
 In laboratory animals, effects on the nervous system have been seen within the range of Category 2 or "Not classified." In a 2-year repeated dose toxicity study using rats dosed by feeding, decreased weight gain and inhibition of erythrocyte acetylcholinesterase activity (20% or more) were observed at 1,000 ppm (50 mg/kg/day), which corresponds to Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
 Additionally, in a 103-week carcinogenicity study using rats dosed by feeding, it was reported that chronic ulcer of the stomach in males and fatty degeneration of the liver and chronic inflammation of the kidneys in females were observed at 2000 ppm (100 mg/kg/day), which is the upper limit of Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). However, this data was not adopted because the Food Safety Commission of Japan regarded it as insufficient data and material only for a reference.
 Therefore, this substance was classified in Category 1 (nervous system)
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 48-hour EC50 = 1.0 ppb for crustacea (Daphnia magna) (U.S.EPA: RED, 2006, 2009), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 1


Warning
H410 P273
P391
P501
 If chronic toxicity data are used, it was classified in Category 1 due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 22 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 21-day NOEC = 0.06 ppb for crustacea (Daphnia magna) (U.S.EPA: RED, 2006, 2009),.
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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