GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 1929-82-4
Chemical Name 2-Chloro-6-trichloromethylpyridine; Nitrapyrin
Substance ID R01-B-052
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 FY2018   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 (2001)), but the classification is not possible due to no data.
8 Self-reactive substances and mixtures *
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9 Pyrophoric liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10 Pyrophoric solids *
-
-
- - No data available.
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 *
-
-
- - 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 (Not applicable)."
13 Oxidizing liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14 Oxidizing solids *
-
-
- - The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
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 *
-
-
- - Classification is not possible because test methods applicable to solid substances are not available.
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) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 4.

[Evidence Data]
(1) LD50 for rats: 940 mg/kg (ACGIH (7th, 2019))
(2) LD50 for rats: males: 1,070 mg/kg, females: 1,230 mg/kg (EPA Pesticide (2005), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007))
1 Acute toxicity (Dermal) *
-
-
- - [Rationale for the Classification]
Based on (1), by putting an emphasis on a GLP test and adopting it, it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rabbits: >2,000 mg/kg (EPA Pesticide (2005), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007))

[Reference Data, etc.]
(2) LD50 for rabbits: 850 mg/kg (ACGIH (7th, 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), since the category could not be specified, it was classified as "Classification not possible."

[Evidence Data]
(1) LC50 (4 hours) for rats: >0.03 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), EPA Pesticide (2005))
2 Skin corrosion/irritation *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified." The category was changed due to new data obtained.

[Evidence Data]
(1) In a skin irritation test with rabbits according to OECD TG 404 and EPA OPPTS 870.2500, mean scores at 24/48/72 hours were all less than 2.3 (REACH registration dossier (Access on September 2019), EPA Pesticide (2005), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
[Rationale for the Classification]
Based on (1), it was classified in Category 2A.

[Evidence Data]
(1) In an eye irritation test with rabbits according to OECD TG 405 and EPA OPPTS 870.2400, the mean scores at 24/48/72 hours for conjunctival redness/edema, corneal opacity and the iris were 2.6/1.3, 0.3 and 1.0, respectively. In addition, all were resolved 21 days post-exposure (REACH registration dossier (Access on September 2019), EPA Pesticide (2005), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
4 Respiratory sensitization *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization *
-
-
- - [Rationale for the Classification]
Though there is data in (1), it was not data of a standard test. Therefore, it was classified as "Classification not possible" due to lack of data.

[Reference Data, etc.]
(1) In a skin sensitization test (modified Maguire method) with guinea pigs, a positive result (positive rate 30%) was reported (EPA Pesticide (2005), REACH registration dossier (Access on September 2019), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
5 Germ cell mutagenicity *
-
-
- - [Rationale for the Classification]
From (1) and (2), based on expert judgment, it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, there is a report of a negative result in a micronucleus test with mice (EPA Pesticide (2005), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
(2) As for in vitro, there are reports of negative results in bacterial reverse mutation tests, except for some bacterial strains, and an unscheduled DNA synthesis test and a gene mutation test (HGPRT) with cultured mammalian cells (EPA Pesticide (2005), NTP DB (Access on July 2019), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).

[Reference Data, etc.]
(3) It is predicted that this substance is mutagenic based on certain structural activity factors (EPA Pesticide (2005)).
(4) It was concluded that no effects on fertility, no teratogenicity and no genotoxicity causing trouble in vivo were observed in the results of various toxicity tests (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
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 for the classification results by domestic and international organizations, it was classified as A4 by ACGIH (ACGIH (7th, 2019)), as "NL (Not Likely to be Carcinogenic to Humans)" by EPA (EPA Annual Cancer Report (2018): classified in 2018).
7 Reproductive toxicity *
-
-
- - [Rationale for the Classification]
Based on (1)-(3), since no reproductive toxicity corresponding to any category was observed, it was classified as "Not classified." The classification result was changed by the use of new information sources.

[Evidence Data]
(1) In a two-generation reproduction toxicity study with rats by oral dose, increased absolute and relative weights of the liver and kidney, and diffuse centrilobular hepatocyte hypertrophy were observed in parental animals, and decreased body weight gain and centrilobular hepatocyte vacuolation with fatty degeneration in the liver were observed in pups. However, no effects on fertility were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
(2) In a developmental toxicity test in which female rats were orally administered on gestational days 6-15, a decrease in body weights, and increases in skeletal variations (lumbar ribs) and delayed ossification of the sternebra were observed in pups at the dose where maternal toxicity (decreased body weight gain and decreased feed consumption) was observed. However, no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
(3) In a developmental toxicity test in which female rabbits were orally administered on gestational days 6-18, an increased incidence of crooked hyoid bones was observed in pups at the dose where maternal toxicity (decreased body weight gain and increased absolute and relative weights of the liver) was observed. However, no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
8 Specific target organ toxicity - Single exposure Category 2 (central nervous system)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
[Rationale for the Classification]
The reports of single inhalation exposure in humans to this substance were not obtained from information sources in List 1 and List 2. Based on information about experimental animals in (1), it was classified in Category 2 (central nervous system). Since information adopted as evidence of respiratory tract irritation in the previous classification was from the reference in List 3, it was not adopted. Therefore, the classification result was changed.

[Evidence Data]
(1) In an acute neurotoxicity test with rats, following a single oral dose of 400 mg/kg (corresponding to Category 2) of this substance, slight tremors, gait incoordination and decreased total motor activity were observed (Federal Register vol. 82, No. 229, November 30, 2017).

9 Specific target organ toxicity - Repeated exposure Category 2 (liver, kidney)


Warning
H373 P260
P314
P501
[Rationale for the Classification]
Based on (1)-(4), since effects on the liver and kidney were observed within the range of Category 2 by oral administration to experimental animals, it was classified in Category 2 (liver, kidney).

[Evidence Data]
(1) In a test in which rats were dosed by feeding for 90 days, increased weight of the liver, hepatocyte hypertrophy, lesions of the renal tubules, etc. were observed at or above 40 mg/kg/day (within the range of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
(2) In a combined chronic toxicity/carcinogenicity study (feeding) with rats for 2 years, increased weights of the liver and kidney, hepatocellular hypertrophy and vacuolation (fatty degeneration), and chronic progressive glomerulonephropathy were observed in males and females at 60 mg/kg/day (within the range of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007), EPA Pesticide (2005)).
(3) In a carcinogenicity study (feeding) with mice for 2 years, homogeneous cellular changes in the centrilobular hepatocytes were observed in males and females at 25 mg/kg/day (within the range of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
(4) In a chronic toxicity test (feeding) with dogs for 1 year, increases in ALP activity and total cholesterol concentration, increased weight of the liver and hepatocyte hypertrophy were observed at 15 mg/kg/day (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2007)).
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) -
-
-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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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