GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 51218-49-6
Chemical Name 2-chloro-2',6'-diethyl-N-(2-propoxyethyl)acetanilide [Pretilachlor]
Substance ID H28-B-068, C-147B
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 Classification not possible
-
-
- -  No data available.
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 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).
13 Oxidizing liquids Not applicable
-
-
- -  The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen.
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) Not classified
-
-
- -  Based on the LD50 values for rats of 3,600 mg/kg (male) and 2,200 mg/kg (female) (Evaluation of effect for the food safety (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (Access on October 2016)), this substance was classified as "Not classified" (Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Not classified
-
-
- -  Based on the LD50 value for rats of > 4,000 mg/kg (female and male) (Evaluation of effect for the food safety (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (Access on October 2016)), this substance was classified as "Not classified."
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) Classification not possible
-
-
- -  Classification not possible due to lack of data.
 Besides, an LC50 (4 hours) value for rats of > 2.8 mg/L (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)) is reported, and it corresponds to Category 4 to "Not classified," but it is not possible to specify the category from only this value.
 Besides, since the LC50 value is higher than the saturated vapor pressure concentration (0.082 microg/L), the reference value of mist was applied.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
 In a skin irritation test using rabbits, primary skin irritation index was 2.3 for the intact skin immediately after application and 24 hours later, and an average score of erythema was 1.5-2 (4 out of 6 animals) and a score of edema was less than 1 (4 out of 6 animals) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Based on these results, this substance was evaluated as moderately irritating (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), Japan crop protection association (Access on October 2016)).
 Therefore, it was classified in Category 2.
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
 In an eye irritation test using rabbits, the eye irritation score (corresponding to AOI) of the non-washed eye was 4.7 (maximum value 110), and the reaction completely disappeared after 3 days (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Since the eye irritation of this substance is considered to be very slight (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), Japan crop protection association (Access on October 2016)), this substance was classified in Category 2B.
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 in a skin sensitization test (Buehler test) using guinea pigs, it was positive (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). In addition, also in skin sensitization tests (Optimization test (test method that is not approved by OECD)) using guinea pigs, positive result is reported (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). Therefore, this substance was classified in Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- -  The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, micronucleus tests using bone marrow cells of rats and mice were negative (Evaluation of effect for the food safety (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), Japan Crop Protection Association (Access on October 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). As for in vitro, bacterial reverse mutation tests and mammalian cell chromosomal aberration test were negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), Japan Crop Protection Association (Access on October 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
6 Carcinogenicity Not classified
-
-
- -  In 2-year carcinogenicity studies using rats or mice dosed by feeding, no increase in the incidence of neoplastic lesions associated with the administration of this substance was observed in rats. In mice, increased incidence of hepatocellular adenomas was observed in males of 1,000 ppm (33/80 animals, 41.3%) and in females of 3,000 ppm (18/80 animals, 22.5%). However, since in both males and females, there was no dose-dependency in the incidence, and they were within the range of historical data (male: 22.0-49.0%, female: 6.0-24.0%), etc., it was judged that the development of hepatocellular adenomas was not the effects by administration of the test substance, and it was concluded that this substance does not have carcinogenicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). Therefore, this substance was classified as "Not classified."
7 Reproductive toxicity Not classified
-
-
- -  In a 2-generation reproductive toxicity study using rats by oral route (administration by feeding), even when it was administered at up to doses (300-3,000 ppm) where general toxicity effects (weight gain suppression, reduced food consumption, increased relative weight of the liver and kidney) occurred in F0-F2 parent animals, there were no effects on reproductive ability, and only general toxicity effects (weight gain suppression, increased relative liver weight, decreased relative spleen weights) were observed in F1-F2 pups. In addition, in developmental toxicity studies using pregnant rats and pregnant rabbits dosed by gavage during the organogenesis period (rats: Day 7 to 17 of gestation, rabbits: Day 6 to 19 of gestation), in both rats and rabbits, even at the doses (150-300 mg/kg/day) where maternal toxicity was manifested, no abnormality was observed in the fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). From the above, this substance was classified as "Not classified" for this hazard class since this substance shows only general toxicity effects, but no reproductive and developmental toxicity.
8 Specific target organ toxicity - Single exposure Category 2 (central nervous system)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
 It is described that in single dose studies using rats and mice orally given this substance, vomiting-like behavior, piloerection, systemic convulsion, decreased locomotor activity, diarrhea, incontinence, sedation, and weakness were observed at 1,000 mg/kg, corresponding to Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). In addition, it is reported that in a single dermal dose study using rats, vomiting-like behavior and slight systemic convulsion were observed at 4,000 mg/kg, which is above Category 2, but that there was no death case (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). From the above, this substance was classified in Category 2 (central nervous system).
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney)


Warning
H373 P260
P314
P501
 There is no information on humans.
 As for experimental animals, in a 2-year repeated dose toxicity study using rats dosed by feeding, increase in relative weights of the liver and spleen, increase in absolute and relative weights of the kidney and adrenal gland, fine granular surface of the kidney, and chronic nephropathy (glomerular sclerosis, fibrosis, nephrosis) in males, and increase in blood glucose in females were observed at 300 ppm (male: 18.3 mg/kg/day, female: 18.5 mg/kg/day), which is equivalent to category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)).
 Therefore, this substance was classified in Category 2 (kidney).
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 72-hour ErC50 = 0.0032 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)), 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, then it is classified in Category 1 due to being not rapidly degradable (BIOWIN), and 72-hour NOEC (r) = 0.00038 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)).
 If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (BIOWIN), and 96-hour LC50 = 2.4 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)).
 It was classified in Category 1 by drawing a comparison between the above results.
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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