GHS Classification Results by the Japanese Government
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 15972-60-8 |
| Chemical Name | 2-chloro-2',6'-diethyl-N-(methoxymethyl)acetanilide; Alachlor |
| Substance ID | R02-B-098-MHLW, MOE |
| Classification year (FY) | FY2020 |
| 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 (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) | MHLW Website (in Japanese Only) |
| Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
| OECD/eChemPortal (External link) | eChemPortal |
| 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. It was classified as "Not classified." |
| 2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified." |
| 4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 7 | Flammable solids | Classification not possible |
- |
- | - | No data available. Besides, there is information that it is combustible (GESTIS (Access on June 2020)). |
| 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. It was classified as "Not classified." |
| 9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable at up to 150 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | 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 | 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). It was classified as "Not classified." |
| 13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
| 14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. It was classified as "Not classified." |
| 15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified." |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | 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 | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
| 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 |
[Rationale for the Classification] It was classified in Category 4 from (1) - (3). [Evidence Data] (1) LD50 for rats: 930 mg/kg (ACGIH (7th, 2014), EPA Pesticides RED (1998), GESTIS (Access on June 2020), HSDB (Access on June 2020)) (2) LD50 for rats: females: 1,150 mg/kg, males: 1,500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)) (3) LD50 for rats: 1,350 mg/kg (Japanese Journal of Pesticide Science Vol. 24, No. 1 (Pesticide Science Society of Japan, 1998), HSDB (Access on June 2020)) |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rabbits: 13,300 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), ACGIH (7th, 2014), EPA Pesticides RED (1998), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)) |
| 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) | Classification not possible |
- |
- | - | [Rationale for the Classification] The category could not be specified from (1), (2), and it was classified as "Classification not possible." Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (3.2E-004 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) LC50 for rats (4 hours): > 1.04 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), EPA Pesticides RED (1998), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), HSDB (Access on June 2020)) (2) LC50 for rats (4 hours): > 5.1 mg/L (HSDB (Access on June 2020)) (3) Vapor pressure of this substance: 2.20E-005 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 3.2E-004 mg/L) |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" (corresponding to Category 3 in UN GHS classification) from (1) - (5). [Evidence Data] (1) It was slightly irritating in a skin irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) This substance did not produce significant eye or skin irritation in rabbits (ACGIH (7th, 2014)). (3) It is reported that in a skin irritation test with rabbits according to EPA OPPTS 870.2500 on this substance, there was no significant irritation, and it was judged as toxicity Category IV (at 72 hours after application, slight irritation (no irritation or slight erythema)) (EPA Pesticides RED (1998)). (4) In a skin irritation test by 24-hour application of this substance to rabbits, very slight to slight erythema and edema were observed, the primary irritation index was 1.9 (maximum 8), and it was reported to be slightly irritating (Japanese Journal of Pesticide Science Vol. 24, No. 1 (Pesticide Science Society of Japan, 1998)). (5) In a skin irritation test by 24-hour application of this substance to rabbits, the mean score for erythema was both 1.0 at 24 and 72 hours after application, the mean score for edema was 1.0 and 0.5, and it was judged as slightly irritating (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), HSDB (Access on June 2020)). |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1) - (5). [Evidence Data] (1) It was slightly irritating in an eye irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) This substance did not produce significant eye or skin irritation in rabbits (ACGIH (7th, 2014)). (3) It is reported that in an eye irritation test with rabbits according to EPA OPPTS 870.2400, this substance did not cause significant irritation, and it was judged as toxicity Category IV (slight effects disappearing within 24 hours) (EPA Pesticides RED (1998)). (4) In an eye irritation test with rabbits on this substance, no significant irritation response was seen, the primary irritation index was 0.4 (maximum 110), and this substance was reported as not irritating (Japanese Journal of Pesticide Science Vol. 24, No. 1 (Pesticide Science Society of Japan, 1998)). (5) In an eye irritation test with rabbits on this substance, slight conjunctival redness was found at 1 and 2 days after application and completely disappeared by 72 hours after application (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), HSDB (Access on June 2020)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] 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 |
[Rationale for the Classification] It was classified in Category 1 from (1) - (4). [Evidence Data] (1) It was sensitizing in a skin sensitization test with guinea pigs (Buehler test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) This substance was a sensitizer in guinea pigs (ACGIH (7th, 2014)). (3) It was reported to be positive in a skin sensitization test with guinea pigs according to EPA OPPTS 870.2600 (EPA Pesticides RED (2007)). (4) In a skin sensitization test with guinea pigs (modified Buehler test) on this substance, 8/10 animals were judged as having a positive response (Japanese Journal of Pesticide Science Vol. 24, No. 1 (Pesticide Science Society of Japan, 1998), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). [Reference Data, etc.] (5) It was classified in Skin Sens. 1 (H317) in EU-CLP classification (EU CLP classification (Access on June 2020)). |
| 5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1) - (4). [Evidence Data] (1) As for in vivo, it was reported to be negative in micronucleus tests with bone marrow cells from rats or mice, a chromosomal aberration test with the rat liver, and a comet assay with cells from the upper part of the rat nose. On the other hand, there were positive and negative results in unscheduled DNA synthesis tests using rat hepatocytes (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), EPA Pesticides RED (1998), ACGIH (7th, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), Food sanitation research Vol. 49, No. 5 (Japan Crop Protection Association, 1999), Japanese Journal of Pesticide Science Vol. 24, No. 1 (Pesticide Science Society of Japan, 1998)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test and a gene mutation test with cultured mammalian cells and positive in a chromosomal aberration test with cultured mammalian cells (same as the above). (3) It is reported that this substance induced DNA adduct formation and increases in single-strand breaks of DNA (ACGIH (7th, 2014)). (4) It is reported that it was considered that this substance did not have genotoxicity that could pose a problem in vivo (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). |
| 6 | Carcinogenicity | Category 2 |
 Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] It was classified in Category 2 from (1) - (3). An investigation was conducted by using new information sources, and the classification result was changed. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in A3 by ACGIH (ACGIH (7th, 2014)), L at high doses and NL at low doses by EPA (Likely to be Carcinogenic to Humans: at High Doses; Not Likely to be Carcinogenic to Humans at Low Doses (EPA Annual Cancer Report 2019 (Access on September 2020): classified in 1997)), and Carc.2 in EU CLP classification (EU CLP classification (Access on May 2020)). (2) Three combined chronic toxicity/carcinogenicity tests by 2-year diet administration of this substance to male and female rats were conducted, significant increases in the number of animals with glandular stomach tumors and incidences of malignant neuroendocrine cell tumors and respiratory epithelial adenoma of the nose were observed, and glandular stomach carcinosarcoma, and thyroid adenoma and adenocarcinoma were found (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (3) In two carcinogenicity tests by 18-month diet administration of this substance to male and female mice, no treatment-related increases in the incidences of neoplastic lesions were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). |
| 7 | Reproductive toxicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a three-generation reproductive study with rats dosed by feeding, an increase in kidney weight was observed in offspring at a dose at which parental toxicity (increases in kidney weight, chronic nephritis, ovary weight, etc.) was observed, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, no effect in fetuses was observed even at a dose at which maternal toxicity (suppressed body weight gain and a decrease in food consumption) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). [Reference Data, etc.] (3) In a developmental toxicity study with female rats dosed by gavage on days 6 to 19 of gestation, effects on fetuses (a slight increase in the mean number of post-implantation embryonic deaths and a decrease in the mean number of live fetuses due to a slight increase in early and late resorptions) were observed at a dose at which severe maternal toxicity (deaths (4/25 animals), loose stool, suppressed body weight gain, etc.) was observed, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (nervous system), Category 3 (respiratory tract irritation) |
Warning |
H371 H335 |
P308+P311 P260 P264 P270 P405 P501 P304+P340 P403+P233 P261 P271 P312 |
[Rationale for the Classification] There was no report on acute exposure effects of this substance in humans. Based on (1) and (2), it was classified in Category 2 (nervous system) and Category 3 (respiratory tract irritation). New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) In an acute inhalation exposure test with rats, secretory irritation and mild respiratory irritation effect were observed at 1.04 mg/L (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (2) In an acute oral toxicity test with rats (the minimum dose at which effects were observed was not described, and it was assumed that effects were observed at least around the LD50 value (930 mg/kg, within the range for Category 2)), ataxia, tremor, hyperactivity, lethargy, dyspnea, and convulsions were observed, and in an acute inhalation exposure test (the minimum dose at which effects were observed was not described, and it was assumed that effects were observed at least around the LD50 value (1.04 mg/L, within the range for Category 2)), inflammations of the eye and nose were observed (HSDB (Access on June 2020)). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (nasal cavity, liver) |
Warning |
H373 | P260 P314 P501 |
[Rationale for the Classification] There was no report on hazards by repeated exposure to this substance in humans. In test animals, effects on the nasal cavity and liver were observed at doses of Category 2 in (1) to (3), and therefore, it was classified in Category 2 (nasal cavity, liver). With the addition of new information, the classification results were changed from the previous classification. [Evidence Data] (1) It was reported that, in a 6-month oral toxicity test with dogs dosed by capsules, at or above 25 mg/kg/day (within the range for Category 2), an increase in mortality, increases in ALT and ALP, and an increase in relative liver weight were observed, and furthermore, an increase in blood urea nitrogen and hepatic fatty degeneration in males, and a decrease in total protein and hepatic bile duct proliferation in females were observed; and at or above 50 mg/kg/day (within the range for Category 2), a decrease in total protein, an increase in absolute liver weight, and hepatic bile duct proliferation in males, and hepatic fatty degeneration in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013)). (2) It was reported that, in a two-year test with rats dosed by feeding (males: 27 months, females: 25 months), at or above 42 mg/kg/day (within the range for Category 2), centrilobular hepatocellular hypertrophy and ground glass-like hepatocellular cytoplasmic degeneration were observed, and furthermore in males, hepatocellular cytoplasmic layer structure and centrilobular hepatocellular necrosis were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), ACGIH (7th, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (3) It was reported that, in a two-year test with rats dosed by feeding, nasal submucosal gland hyperplasia and inflammation of the nasal cavity were observed at 15 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center) (2012)). [Reference Data, etc.] (4) It was reported that, in the two-year test with rats dosed by feeding (males/females: 27/25 months), ocular lesions were observed at or above 14 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), ACGIH (7th, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)), and this was considered to be specific to rats (strain: Long Evans), and not reproducible in humans (EPA Pesticides RED (1998), ACGIH (7th, 2014)). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
| 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 96-hour ErC50 = 0.0047 mg/L for algae (Raphidocelis subcapitata) (Document for registration standards for agricultural chemicals set by the Minister of Environment to prevent harm to animals and plants in areas of public waters, 2013). |
| 11 | Hazardous to the aquatic environment Long term (Chronic) | Category 1 |
Warning |
H410 | P273 P391 P501 |
It was classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 0.001 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
NOTE:
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