GHS Classification Results by the Japanese Government

日本語で表示



GENERAL INFORMATION
Item Information
CAS RN 115-32-2
Chemical Name 2,2,2-trichloro-1,1-bis(4-chlorophenyl)ethanol; Dicofol
Substance ID R02-B-061-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

PHYSICAL HAZARDS
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 (ICSC (2003)).
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 Classification not possible
-
-
- - No data available.
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
-
-
- - Classification is not possible because test methods applicable to solid substances are not available.
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."

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]
It was classified in Category 4 from (1) - (6).

[Evidence Data]
(1) LD50 for rats: 575 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), GESTIS (Access on May 2020))
(2) LD50 for rats: 578 mg/kg (JMPR (2011))
(3) LD50 for rats: females: 578 mg/kg, males: 595 mg/kg (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 12 (Japan Crop Protection Association, 1992))
(4) LD50 for rats: 587 mg/kg (EPA Pesticides RED (1998))
(5) LD50 for rats: males: 595 mg/kg (HSDB (Access on May 2020))
(6) LD50 for rats: 684-809 mg/kg (HSDB (Access on May 2020))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1) - (3).

[Evidence Data]
(1) LD50 for rabbits: 2,000-5,000 mg/kg (HSDB (Access on May 2020))
(2) LD50 for rabbits: > 2,000 - < 5,000 mg/kg (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 12 (Japan Crop Protection Association, 1992))
(3) LD50 for rats: > 5,000 mg/kg (JMPR (2011), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 12 (Japan Crop Protection Association, 1992))
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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).
Besides, because an exposure concentration was higher than the saturated vapor pressure concentration (8.0E-006 mg/L), a reference value in the unit of mg/L was applied as dust.

[Evidence Data]
(1) LC50 for rats (4 hours): > 5 mg/L (GESTIS (Access on May 2020))
(2) Vapor pressure of this substance: 3.98E-007 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 8.0E-006 mg/L)
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
[Rationale for the Classification]
It was classified in Category 2 from (1) - (3). Because rationale data for the previous classification could not be confirmed, based on newly obtained data in (1) - (3), the classification result was changed.

[Evidence Data]
(1) In a skin irritation test with rabbits, very slight to well-defined erythema was observed in 2/6 animals at 1 hour after removal of patches. Well-defined to
moderate to severe erythema was found after 24, 48, and 72 hours and disappeared after 7 days. Very slight to severe edema was present in all animals at 1 hour after removal of patches and persisted through 72 hours but disappeared on day 7. The primary irritation index (PII) was 4.8, and it was considered as a slight to moderate irritant (JMPR Addendum (2011)).
(2) It was a moderate irritant in a skin irritation test with rabbits according to EPA OPP 81-5 (EPA Pesticides RED (1998)).
(3) In humans, short-time exposure irritates the eye and skin and causes erythema. Long-term or repeated contact with the skin may cause dermatitis (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).

[Reference Data, etc.]
(4) In skin irritation tests with rabbits using emulsion (active ingredient 51%) and wettable powder (active ingredient 35%) of this substance, it was judged as a moderate to severe irritant (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 12 (Japan Crop Protection Association, 1992)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
[Rationale for the Classification]
It was classified in Category 2B from (1) - (3). Because it was classified in Category 1 based on the result in formulation (wettable powder) in the previous classification, the classification result was changed based on the result in this substance itself.

[Evidence Data]
(1) In an eye irritation test with rabbits (eyes were irrigated at 24 hours after application), there were no effects on the cornea and iris, but conjunctival effects were observed in 6/6 animals after 1 and 24 hours and 5/6 animals after 48 hours and disappeared within 72 hours, and this substance was considered to be a slight to moderate eye irritant (JMPR Addendum (2011)).
(2) It was a moderate irritant in an eye irritation test with rabbits according to EPA OPP 81-4 (EPA Pesticides RED (1998)).
(3) In humans, short-term exposure irritates the eye and skin and produces erythema (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).

[Reference Data, etc.]
(4) In an eye irritation test with rabbits using emulsion (active ingredient 51%) of this substance, changes were seen in the cornea, conjunctiva, and iris but disappeared by 7 days (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 12 (Japan Crop Protection Association, 1992)).
(5) In an eye irritation test with rabbits using wettable powder (active ingredient 35%) of this substance, changes were observed in the cornea, conjunctiva, and iris, and reactions in the conjunctiva and iris disappeared by 14 days, but changes in the cornea persisted after 21 days (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 12 (Japan Crop Protection Association, 1992)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - [Rationale for the Classification]
There were descriptions in (1) - (3), but because contradicting data were mixed, and a clear conclusion could not be obtained, the classification was not possible. Because data that contradicted the previous classification were obtained, the classification result was changed.

[Evidence Data]
(1) It was reported to be a slight to moderate sensitizer in a skin sensitization test with guinea pigs (Buehler test) (JMPR (2011)).
(2) In a skin sensitization test with guinea pigs by a modified Buehler test (induction: 10-time applications of a 4.2% solution, 6 hours/application, 3 times/week, 3.5 weeks, challenge: an 11.7% solution, 2 weeks after the last induction, rechallenge 1 week later), erythema was observed in part of the animals, but no clear difference from the control group was seen, and no clear conclusion on sensitization was reached (JMPR Addendum (2011)).
(3) It was a non-sensitizer in a skin sensitization test with guinea pigs according to EPA OPP 81-6 (EPA Pesticides RED (1998)).

[Reference Data, etc.]
(4) It was judged as a slight sensitizer in skin sensitization tests with guinea pigs using emulsion (active ingredient 43.8%) and wettable powder (active ingredient 36.2%) of this substance (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 12 (Japan Crop Protection Association, 1992)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) As for in vivo, it was reported to be negative in a chromosomal aberration test with bone marrow cells after oral administration to rats (EPA Pesticides RED (1998), JMPR addendum (2011), HSDB (Access on May 2020), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 12 (Japan Crop Protection Association, 1992)).
(2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test (EPA Pesticides RED (1998), JMPR addendum (2011), HSDB (Access on May 2020), CEBS (Access on May 2020), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 12 (Japan Crop Protection Association, 1992)). As for test systems using cultured mammalian cells, it was reported to be negative in a chromosomal aberration test, negative in a gene mutation test (EPA Pesticides RED (1998), JMPR addendum (2011), HSDB (Access on May 2020)), and negative in a sister chromatid exchange test (JMPR addendum (2011)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
From (1) - (3), based on EPA's classification result, which was done later (1998) than IARC (1987), it was classified in Category 2. By the study using new information sources, the classification result was changed.

[Evidence Data]
(1) As for classification results by domestic and international organizations, it was classified in Group 3 by IARC (IARC Sup7 (1987)) and Group C (possible human carcinogen) by EPA (EPA Pesticides RED (1998)).
(2) In carcinogenicity tests by 78-week diet administration of this substance to male and female rats and mice, significant increases in the incidences of hepatocellular carcinoma and hepatocellular adenoma and carcinoma (combined) were observed in male mice. No increase in tumor incidence was seen in female mice and male and female rats (NTP TR90 (1978), IARC 30 (1983), EPA Pesticides RED (1998)).
(3) In a combined chronic toxicity/carcinogenicity study by 2-year diet administration of this substance to male and female rats, no treatment-related increases in tumor incidence were observed (JMPR (2011), EPA Pesticides RED (1998)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1), effects on fertility were observed at a dose of parental toxicity. Therefore, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. A new information source was used and the classification results were changed from the previous classification.

[Evidence Data]
(1) In a two-generation reproduction toxicity test with rats dosed by feeding, lower survival rate of offspring was observed at a dose at which parental toxicity (reduced body weight gain, a decrease in food consumption, increases in the incidence of hypertrophy and/or vacuolation of the adrenal cortex, hypertrophy of interstitial cells in the ovary, and degeneration of hepatocytes) was observed (Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), JMPR (1992), JMPR addendum (2011)).

[Reference Data, etc.]
(2) In a developmental toxicity study with female rats dosed by gavage on days 6-15 of gestation, no effect was observed in fetuses even at a dose at which maternal toxicity (excessive salivation, reduced body weight gain, centrilobular hepatocyte hypertrophy, etc.) was observed (Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 12 (Japan Crop Protection Association, 1992), JMPR (1992), JMPR addendum (2011)).
(3) In a developmental toxicity study with female rabbits dosed by gavage on days 7-19 of gestation, miscarriage was observed at a dose at which maternal toxicity (reduced body weight, eosinophilic and hyaline material in centrilobular hepatocytes) was observed, but no effect was observed in offspring (Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" Vol. 12 (Japan Crop Protection Association, 1992), JMPR (1992), JMPR addendum (2011)).
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 1 (central nervous system) and Category 3 (narcotic effects). A new information source was used and the classification results were changed from the previous classification.

[Evidence Data]
(1) Such acute symptoms as reddening of the eye or skin, confusion, convulsions, coughing, dizziness, headache, nausea, vomiting, a feeling of weakness, and disorientation appeared, and after oral ingestion, abdominal pains and diarrhea were also observed (Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).
(2) In one person who orally ingested this substance (ingested amount unknown), nausea, dizziness, and vomiting were observed. It was reported that in three persons who were exposed by inhalation to this substance (concentration unknown), dizziness, and a feeling of weakness were observed, and vomiting in two of them, and nasal obstruction in one of them also occurred (Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).
(3) In a case of a 12-year-old boy exposed to this substance via dermal route by accidentally falling into a pool of a spilled undiluted solution of formulation of this substance (470 g/L), such initial symptoms as nausea, dizziness, disorientation, confusion, lethargy, and headache appeared, and lateral nystagmus and a reduced sense of balance were also observed, but these symptoms disappeared in 3 weeks. As a result of a neuropsychological test 8 months after the exposure, impairment of cognitive functions, such as auditory reflex, immediate memory, and ability to inhibit an inappropriate response, was observed, and the cognitive impairment and emotional disturbance continued for 18 months (Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, adrenal gland), Category 2 (nervous system)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1) to (5), it was classified in Category 1 (liver, adrenal gland) and Category 2 (nervous system). In a test with rats in (1), effects on the thyroid were also observed within the range for Category 1, but they were determined to be secondary changes (physiological changes of the thyroid axis related to hepatic enzyme induction) of effects on the liver, and the thyroid was not considered as a target organ. In a test with dogs in (3), inhibition of the central nervous system, effects on the heart and testis, and oligospermia were also observed within the range for Category 2, but these effects were not observed in a longer test in (5), and those organs were not considered as target organs. The data for the rationale for the previous classification could not be referred to, and as a result of review using the information of the sources in List 1 and 2, the classification results were changed from the previous classification.

[Evidence Data]
(1) In a 13-week test with rats dosed by feeding, thyroid follicular cell hypertrophy in males at or above 10 ppm (males/females: 0.64/0.78 mg/kg/day, within the range for Category 1); enhanced hepatic mixed function oxidase (MFO) activity and hepatocyte hypertrophy in males and females at or above 100 ppm (males/females: 6.49/7.84 mg/kg/day, within the range for Category 1); an increase in liver weight, a decrease in blood corticosterone concentrations, and vacuolation of the adrenal cortex in males and females, and thyroid follicular cell hypertrophy in females at or above 500 ppm (males/females: 32.01/36.11 mg/kg/day, within the range for Category 2); and deaths (5/10 males, 8/10 females), ataxia, and lethargy in males and females at 1,500 ppm (males/females: 95.84/105.91 mg/kg/day, within the range for Category 2 for males, and exceeding Category 2 for females) were observed (EPA Pesticides RED (1998), Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), JMPR addendum (2011)).
(2) In a 13-week test with mice dosed by feeding, enhanced hepatic MFO activity in males and females, and an increase in liver weight in females at or above 125 ppm (males/females: 18.2/29.3 mg/kg/day, within the range for Category 2); hepatocyte hypertrophy in males and females, and enhanced GTP activity in females at or above 250 ppm (males/females: 38.2/56.2 mg/kg/day, within the range for Category 2); and adrenal cortical cell hypertrophy, hepatocyte necrosis, and vacuolation in males and females, and degeneration of the kidney in females at or above 500 ppm (males/females: 84.4/108.0 mg/kg/day, within the range for Category 2 for males, and exceeding Category 2 for females) were observed (Same as above).
(3) In a 3-month test with dogs dosed by feeding, a decrease in cortisol release in response to adrenocorticotropic hormone (ACTH) administration, and oligospermatogenesis in males at or above 100 ppm (males/females: 3.3/3.4 mg/kg/day, within the range for Category 1); labored breathing, inactivity, dehydration, diarrhea, incoordination, excessive salivation, and prolongation of QT interval in males and females, an increase in liver weight in males, and increases in ALT and ALP activity in females at or above 300 ppm (males/females: 9.9/9.8 mg/kg/day, within the range for Category 1); and histopathological changes in the liver, testis, and heart in males and females, and an increase in liver weight in females at 1,000 ppm (males/females: 26/27 mg/kg/day, within the range for Category 2) were observed (EPA Pesticides RED (1998), JMPR addendum (2011)).
(4) As a result of a 24-month test with rats dosed by feeding, enhanced hepatic MFO activity, centrilobular hypertrophy, vacuolation, and acidophilic changes of hepatocytes, and diffuse vacuolation of the adrenal cortex zona fasciculata and reticularis in males and females, an increase in liver weight in males at or above 50 ppm (males/females: 2.23/2.69 mg/kg/day, within the range for Category 1); and reduced body weight gain in males and females, and an increase in liver weight, focal hepatocyte hyperplasia, and chronic cystitis in females at 250 ppm (males/females: 11.34/14.26 mg/kg/day, within the range for Category 2) were observed (EPA Pesticides RED (1998), Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), JMPR addendum (2011)).
(5) As a result of a 52-week test with dogs dosed by feeding, hepatocyte hypertrophy, toxic effects in the adrenal gland, a slight increase in ALP activity, a decrease in albumin concentration, and reduced cortisol release in an ACTH stimulation test were observed in males and females at 180 ppm (males/females: 5.71/5.42 mg/kg/day, within the range for Category 1) (IARC (1983), EPA Pesticides RED (1998), Environmental Risk Assessment for Chemical Substances Vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), JMPR addendum (2011)).

[Reference Data, etc.]
(6) In 28-day dermal toxicity tests with rats and rabbits, only a decrease in body weight and centrilobular hepatocyte hypertrophy in the liver (rats) were observed at doses of which converted guidance values corresponded to Category 2 (rats: 12 mg/kg/day; rabbits: 19 mg/kg/day) (EPA Pesticides RED (1998)).
10 Aspiration hazard Classification not possible
-
-
- - [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) Category 1


Warning
H400 P273
P391
P501
It was classified in Category 1 from 48-hour EC50 = 0.096 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998)).
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 NOEC = 0.0084 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002)).
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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.

To GHS Information