GHS Classification Result

日本語で表示



GENERAL INFORMATION
Item Information
CAS RN 106-46-7
Chemical Name p-Dichlorobenzene
Substance ID H27-B-046/C-082B_P
Classification year (FY) FY2015
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 FY2009   FY2007   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
-
-
- - Solid (GHS definition).
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Solid (GHS definition).
5 Gases under pressure Not applicable
-
-
- - Solid (GHS definition).
6 Flammable liquids Not applicable
-
-
- - Solid (GHS definition).
7 Flammable solids Classification not possible
-
-
- - It is described in ICSC (2003) that it is combustible, but the classification is not possible due to no data.
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 Not applicable
-
-
- - Solid (GHS definition).
10 Pyrophoric solids Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from the data that it does not ignite up to 500 deg C (HSDB (Access on August 2015)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - 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 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
-
-
- - Solid (GHS definition).
14 Oxidizing solids Not applicable
-
-
- - The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- - A melting point is 53 deg C, and it is solid to which the UNRTDG test method is applicable, but there is no information that the test was conducted.

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 are 10 reports of LD50 values for rats: 500 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002)), 500-1,000 mg/kg (DFGOT vol. 4 (1992), IARC 29 (1982)), > 2,000 mg/kg (EU-RAR (2004), DFGOT Vol. 4 (1992)), 2,515 mg/kg (DFGOT Vol. 4 (1992)), 2,512 mg/kg (NICNAS (2000)), 3,863 mg/kg (males), 3,790 mg/kg (females) (EPA Pesticide (2008), ATSDR (2006), NICNAS (2000), DFGOT Vol. 4 (1992)), 4,000 mg/kg > and > 1,000 mg/kg (NTP TR 319 (1987)), 1,625-3,863 mg/kg (ACGIH (7th, 2001)), and 2,515-3,863 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Two values correspond to Category 4, five correspond to "Not classified" (of which four correspond to Category 5 in UN GHS classification), and one corresponds to "Classification not possible." Accordingly, this substance was classified as "Not classified" (Category 5 in UN GHS classification) to which the larger number of data corresponds. Besides, since two values were based on compilations of multiple pieces of data, they were not adopted as evidence of the classification.
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on reports of LD50 values for rats of > 2,000 mg/kg (EU-RAR (2004), DFGOT vol. 4 (1992)) and > 6,000 mg/kg (EPA Pesticide (2008), ATSDR (2006), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ACGIH (7th, 2001), NICNAS (2000), DFGOT vol. 4 (1992)), and an LD50 value for rabbits of > 5,010 mg/kg (ACGIH (7th, 2001)), this substance was classified as "Not classified."
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Not classified
-
-
- - Based on reports of LC50 values (4 hours) for rats of > 5.07 mg/L (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), EU-RAR (2004), NICNAS (2000), DFGOT vol. 4 (1992)) and > 6.00 mg/L (EPA Pesticide (2008)), this substance was classified as "Not classified." Besides, the reference value for dust was applied as a test substance was a solid.
2 Skin corrosion/irritation Not classified
-
-
- - There are descriptions that in a skin irritation test with rabbits (OECD TG 404), as a result of application of 500 mg of this substance for four hours, slight erythema was observed, but resolved after seven days (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). There is a report that in another skin irritation test with rabbits, moderate to severe erythema was observed but resolved after 72 hours, and the Primary Irritation Index (PII) was 2.9 (EPA Pesticide (2008)). In addition, there is a description that this substance is irritating to the skin (Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002)). From the above, this substance was classified as "Not classified" (Category 3 in UN GHS classification) based on the result of the test complying with an OECD testing guideline.
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
It is reported that, in an eye irritation test with rabbits (OECD TG 405), as a result of application of 500 mg of this substance for 24 hours, conjunctival erythema and oedema were observed, but resolved after 72 hours, and it was slightly irritating to the eyes (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). In another eye irritation test with rabbits, this substance was reported to be moderately irritating since conjunctivitis, iritis, corneal opacity, and corneal vascularization were observed, but resolved within 13 days after application, and an irritation score was 20 (maximum value: 47) (EPA Pesticide (2008)). In addition, there is a report of severe eye irritation in human occupational exposure (NICNAS (2000), ACGIH (7th, 2001)), and there is a description that it is irritating to the eyes and it markedly causes opacity of eyeballs (Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002)). From the above, this substance was classified in Category 2 based on the result of the test complying with an OECD testing guideline. Besides, this substance was classified as "Eye. Irrit. 2 H319" in the EU CLP classification (ECHA CL Inventory (Access on September 2015)).
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 maximization test with guinea pigs, sensitization was observed in 14 out of 24 animals (score 1; 9/24 animals, score 2; 4/24 animals, score 3; 1/24 animal), and there is a sensitization (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). As for humans, a case of a 69-year-old male who developed allergic purpura through dermal contact with an armchair that had been treated with this substance is reported (NICNAS (2000)). Based on the above, this substance was classified in Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, a dominant lethal test with mice was negative, micronucleus tests with rat kidney cells and mouse bone marrow cells were positive and negative results, a micronucleus test with mouse peripheral blood erythrocytes was negative, a chromosome aberration test with rat bone marrow cells was negative, a comet assay with rat kidney, and mouse liver, lung, spleen, kidney, and bone marrow were positive, DNA-adduct formation tests with lung and stomach of rats or mice were positive, DNA-adduct formation tests with rat liver and kidney were positive and negative results, and it was positive in unscheduled DNA synthesis tests with rat kidney and mouse liver and in replicative DNA synthesis tests with liver and kidney of rats, and liver of mice (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), IARC 73 (1999), ACGIH (7th, 2001), ATSDR (2006), EU-RAR (2004), NICNAS (2000), NTP TR 319 (1987)). As for in vitro, in bacterial reverse mutation tests, mammalian cell genetic mutation tests, mouse lymphoma tests, micronucleus tests, and sister chromatid exchange tests, there were many negative results but positive results also existed, and it was negative in mammalian cell chromosome aberration tests and positive in DNA damage tests (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), IARC 73 (1999), NTP TR 319 (1987), ACGIH (7th, 2001), ATSDR (2006), EU-RAR (2004), NICNAS (2000)). From the above, the reproducibility of the positive findings in the micronucleus test could not be confirmed, or was non-standard tests. Therefore, based on the weight-of-evidence principle, it was judged to have no relevant genotoxicity (EU-RAR (2004)). In accordance with the GHS classification guidance for the Japanese government, this substance was classified as "Classification not possible."
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
In humans, although there is one report of five cases of leukemia, epidemiological studies that can evaluate the relationship between exposure specific to this substance and carcinogenicity are considered to be inadequate (NTP RoC (13th, 2014), IARC 73 (1999)). As for experimental animals, 2-year carcinogenicity studies with rats and mice dosed by gavage, in rats, an increased incidence of tubular epithelium cell carcinoma in males, and in mice, increased incidences of hepatocellular adenomas and carcinomas in both sexes were observed (IARC 73 (1999), ACGIH (7th, 2001)). For the inhalation route, in tests in which rats or mice were exposed by inhalation to the vapor of this substance for 76 weeks or 56 weeks, respectively, no increases in incidence of tumors were observed (IARC 73 (1999), ACGIH (7th, 2001)). But, IARC pointed out that the dosage period was short (IARC 73 (1999)). However, it is reported that in a 2-year study in which rats or mice were exposed by inhalation to the vapor of this substance, in a mice test, increased incidences of hepatocellular carcinomas and histiocytic sarcomas in males, and hepatocellular carcinomas, hepatocellular adenomas and bronchiolar-alveolar carcinomas in the lung in females were observed (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on August 2015)). As for classification results by other organizations, it was classified in Group 2B by IARC (IARC 73 (1999)), in A3 by ACGIH (ACGIH (7th, 2001)), in Group 2B by Japan Society For Occupational Health (Recommendation of Occupational Exposure Limits (2015)), in R by NTP (NTP RoC (13th, 2014)), and in Carc. 3 by EU (EU-RAR (2004)), respectively. From the above, it was classified in Category 2 for this hazard class.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
There is no information on the reproductive effects in humans. As for experimental animals, in two-generation reproductive toxicity tests with rats dosed by the inhalation or the oral (gavage) route, at doses where general toxicity effects (reduced body-weight gain, effects on the liver (weight increase, hepatocyte hypertrophy), and effects on the kidney (weight increase, nephrosis), etc. (F0 and F1 males and females (inhalation), F0 and F1 males (oral)) were manifested in parental animals in both routes, increased pre- and postnatal mortality, decreased litter sizes, low value of body weights or decreased body weight gain by weaning, and delayed developmental parameters, etc. in the F1 and F2 pups were observed, but no effects of reproductive toxicity in the parental animals of either generation were shown (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ATSDR (2006)).
With regard to developmental toxicity, in tests in which pregnant rats or pregnant rabbits were exposed by inhalation to the vapor of this substance during organogenesis period, no anomalies were observed in either the parental animals or the fetuses at up to the highest doses (508 ppm (rats), 800 ppm (rabbits)) (EU-RAR (2004), ACGIH (7th, 2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ATSDR (2006)). In addition, in a test in which pregnant rats were dosed by gavage during organogenesis period, reduced body weight gain in maternal animals was observed at or above 500 mg/kg/day, and in the fetuses, an increase in the frequency of skeletal variations (extra ribs) at 500 mg/kg/day and decreased fetal weight at 1,000 mg/kg/day were only observed (EU-RAR (2004), ACGIH (7th, 2001), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ATSDR (2006)). Based on the above findings of the effects of reproductive and developmental toxicity in experimental animals, the Japan Society For Occupational Health (JSOH) classified this substance in Reproductive Toxicants Group 3 (OEL Documentations, 2014), Recommendation of Occupational Exposure Limits (2015)).
As above, as the result of the two-generation reproduction toxicity tests with rats dosed by inhalation and oral routes, there were no adverse effects on the fertility of parental animals, but adverse effects on the occurrence and development at and after birth such as decreased live pups at birth, low value of body weights, and growth delay until weaning were observed at doses where general toxicity effects were manifested in the parental animals. In addition, the classification by the Japan Society For Occupational Health also corresponds to Category 2. Therefore, it was classified in Category 2 for this hazard class.
Besides, in the previous classification (FY 2009), it was classified in Category 1B since adverse effects in the pups were observed at a dose (90 mg/kg/day) where toxicity was not manifested in the F1 parental animals in the two-generation reproductive toxicity test with rats orally dosed. However, there is a description of an effect on the liver (an increase in relative liver weights) in the males also in the group of 90 mg/kg/day in F1 parental animals (EU-RAR (2004)). In this evaluation, taking into account that symptoms of general toxic effects were manifested in the liver in parental animals from the mid-dose, as a result of classification according to the GHS Classification Guidance for the Japanese Government, the category was changed to Category 2.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, haemal system, liver), Category 3 (respiratory tract irritation)



Danger
Warning
H370
H335
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
This substance is irritating to the respiratory tract (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002), OEL Documentations (Japan Society For Occupational Health (JSOH), 1998), ACGIH (7th, 2001), EU-RAR (2004), NICNAS (2000), DFGOT vol. 20 (2003)). As for human cases, there are reports of cough, jaundice, acute hemolytic anemia, and methemoglobinuria in an accident case of a three-year-old boy who orally ingested moth-repellent crystals, of vertigo and anemia in a case of inhalation exposure of a male in a closed room, and of kidney damage in a case of dermal exposure of a male (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002), OEL Documentations (Japan Society For Occupational Health (JSOH), 1998), ACGIH (7th, 2001), EU-RAR (2004), NICNAS (2000), IARC 73 (1999), ATSDR (2006)). There are further descriptions that acute symptoms associated with this substance include effects on the liver, headache, nausea, vomiting, dizziness, central nervous system depression, convulsive seizures, agitation, weakness, methemoglobinemia, and acute hemolytic anemia (ACGIH (7th, 2001), IARC 73 (1999), ATSDR (2006)).
As for experimental animals, there are reports of abnormal gait, hunched posture, an increase in hyaline droplets in the renal cortex (male rats), vacuolation of hepatocytes, and hepatic porphyria (female rats) in oral administration (corresponding to Category 2) to rats. And in inhalation exposure with rats (corresponding to Category 1), there are reports of tremors, reduced reflex, an increase in locomotor activity, piloerection, tremors, loss of reflex, centrilobular hepatocyte hypertrophy, and vacuolation and mild necrosis of hepatocytes, and in males, increased formation of hyaline droplets in the renal cortex (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002), OEL Documentations (Japan Society For Occupational Health (JSOH), 1998), ACGIH (7th, 2001), EU-RAR (2004), NICNAS (2000)).
In humans, there is only one case with kidney damage in human case of dermal exposure and no findings in the kidney were observed in oral and inhalation route. And, in experimental animals, the increase in hyaline droplets in the renal cortex was seen in male rats. Therefore, effects on the kidney were not adopted on this substance.
From the above, effects of this substance were respiratory tract irritation, and those on the central nervous system, haemal system, and liver, and this substance was classified in Category 1 (central nervous system, haemal system, liver), Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system, liver, haemal system), Category 2 (respiratory organs, kidney)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
In humans, systemic petechiae, anemia, jaundice, yellow atrophy of the liver, unsteady gait, paresthesia, and aphasia were seen in vapor exposure (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), and anemia (hypochromia, microcytic anemia, Heinz bodies) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), unsteady gait, tremors of the hands, and decreased mental activity (ACGIH (7th, 2001)) were seen in oral ingestion.
As for experimental animals, in a 5-7 month inhalation toxicity test with rats and guinea pigs, increased liver and kidney weights, and degeneration and edema of hepatocytes were observed at 158 ppm (0.965 mg/L) (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), ATSDR (2006)). In a 16-day inhalation toxicity test with rats and guinea pigs, interstitial edema, congestion, and alveolar hemorrhage were observed in the lungs at 173 ppm (converted guidance value: 0.22 mg/L) (ATSDR (2006)). In a 4-week toxicity test with rats dosed by gavage, tubular nephropathy with dilation and necrosis of tubules at 150 mg/kg/day (converted guidance value: 46.7 mg/kg/day) and increased liver weights, increased kidney weights, and centrilobular hepatocellular hypertrophy at 300 mg/kg/day (converted guidance value: 93.3 mg/kg/day) were observed (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). In a 1-year toxicity test with dogs dosed by gavage, increases in ALT, AST, and GGT activities, increased liver and kidney weights, hepatocellular hypertrophy and pigment deposition, bile duct hyperplasia and hepatic portal inflammation, and renal discoloration and kidney duct epithelial vacuolization were seen at 50 mg/kg/day (EU-RAR (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).
As shown above, in humans, anemia and effects on the central nervous system and liver were seen; in experimental animals, effects were seen in the lung, liver, and kidney. All of these were seen within the range of Category 2.
Therefore, this substance was classified in Category 1 (nervous system, liver, haemal system), Category 2 (respiratory organs, kidney).
Besides, in the previous classification, it was considered that effects were observed in the respiratory system of experimental animals within the range of Category 1. Upon subsequent confirmation, it was in the range of Category 2, therefore, the category was changed.
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 = 0.7 mg/L for crustacea (Daphnia magna) (NICNAS, 2000, EU-RAR, 2004, Initial Risk Assessment (NITE, CERI, NEDO, 2005)), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 1


Warning
H410 P273
P391
P501
Due to being not rapidly degradable (a degradation rate by 4-week BOD = 0%, a degradation rate by HPLC = 0%, a degradation rate by HPLC in an inherent test = 1% (Official Bulletin of Economy, Trade and Industry, 2001)), and 21-day NOEC (reproduction) = 0.1 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1995), Environmental Risk Assessment for Chemical Substances vol. 1 (Ministry of the Environment, 2002), Initial Risk Assessment (NITE, CERI, NEDO, 2005)), it was classified in Category 1.
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.

To GHS Information