GHS Classification Result

日本語で表示



GENERAL INFORMATION
Item Information
CAS RN 95-50-1
Chemical Name o-Dichlorobenzene
Substance ID H27-B-044/C-080B_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 FY2014   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 Category 4
-
Warning
H227 P370+P378
P403+P235
P210
P280
P501
Based on a flash point of 66 deg C (closed cup) (ICSC (2003)), it was classified in Category 4.
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 Not classified
-
-
- - It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 648 deg C (HSDB (Access on August 2015)).
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 (but not fluorine or oxygen) which is 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) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
The following nine reports are available as LD50 values for rats: three reports of 500 mg/kg (ATSDR (2006), Environmental Risk Assessment for Chemical Substances Vol.1 (Ministry of the Environment, 2002), IARC 29 (1982)), two reports of 1,516 mg/kg (ATSDR (2006), NICNAS (2001)), approximately 2,000 mg/kg (males), > 2,000 mg/kg (females) (JECDB (Access on August 2015)), 2,138 mg/kg (NICNAS (2001)), and 1,516-2,138 mg/kg (Hazard Assessment Report (CERI, NITE, 2008), SIDS (2004)). This substance was classified in Category 4 to which the larger number of data (six reports) corresponds.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Category 4


Warning
H332 P304+P340
P261
P271
P312
Based on reported LC50 values for rats of 1,532 ppm (6 hours) (converted 4-hour equivalent value: 3,753 ppm) (PATTY (6th, 2012), ATSDR (2006), EHC 128 (1991)) and 961ppm (7 hours) - 1,532 ppm (6 hours) (converted 4-hour equivalent value: 2,543-3,753 ppm) (Hazard Assessment Report (CERI, NITE, 2008)), this substance was classified in Category 4. In addition, since the LC50 values were lower than the saturated vapor pressure concentration (1,935 ppm), a reference value in the units of ppm was applied as vapor without mist. By correcting the converted 4-hour equivalent value of the LC50 value which was adopted as the evidence for the previous classification, the category was revised.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
There is a report that in a skin irritation test with rabbits, slight to moderate erythema and edema were observed 72 hours after 4-hour application of 0.5 mL of an undiluted solution of this substance (SIDS (2004), Hazard Assessment Report (CERI, NITE, 2008)). It is also reported that edema and blisters were observed as a result of application of this substance in humans (SIDS (2004), DFGOT vol.1 (1990)). From the above, this substance was classified in Category 2. Besides, this substance was classified as "Skin Irrit. 2 H315" in the EU CLP classification (ECHA CL Inventory (Access on September 2015)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
It is reported that slight irritation was observed as a result of application of two drops of an undiluted solution of this substance in the eyes of rabbits (Hazard Assessment Report (CERI, NITE, 2008), ACGIH (7th, 2001)). It is also reported that eye irritation was observed in occupational exposure (SIDS (2004), Hazard Assessment Report (CERI, NITE, 2008)). From the above, this substance was classified in Category 2B. In addition, 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 Classification not possible
-
-
- - Classification not possible due to lack of data.
5 Germ cell mutagenicity Classification not possible
-
-
- - As for in vivo, micronucleus tests with bone marrow cells of mice dosed intraperitoneally were positive and negative results, a micronucleus test with rats dosed subcutaneously was negative, a chromosome aberration test with bone marrow cells of rats dosed intraperitoneally was negative, and a replicative DNA synthesis (RDS) test with mice and DNA-binding tests in rats and mice were negative (Hazard Assessment Report (CERI, NITE, 2008), SIDS (2004), IARC 73 (1999), ATSDR (2006), NICNAS (2001)). As for in vitro, bacterial reverse mutation tests and mammalian cell genetic mutation (hgprt) tests were negative, but in a mouse lymphoma test, a chromosome aberration test, and a sister chromatid exchange test with cultured mammalian cells, positive results were reported in a metabolic activation system (Hazard Assessment Report (CERI, NITE, 2008), SIDS (2004), IARC 73 (1999), ACGIH (7th, 2001), NICNAS (2001), ATSDR (2006), NTP TR 255 (1985), JECDB (Access on August 2015)). From the above, the reproducibility of the positive finding in the in vivo bone marrow micronucleus test could not be confirmed (SIDS (2004)), therefore, this substance was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government.
6 Carcinogenicity Classification not possible
-
-
- - There is no available information for the classification on carcinogenicity in humans. As for experimental animals, carcinogenicity tests were conducted in which rats or mice were dosed by gavage with this substance for two years. In rats, males were dosed at up to doses of 60, 120 mg/kg/day where decreased body weight gain and reduced survival rate were observed, and also in mice, the same doses were given, however, no evidence of carcinogenicity was observed in either sex in either rats or mice (IARC 73 (1999), NTP TR 255 (1985)). Based on these findings, this substance was classified in Group 3 by IARC (IARC 73 (1999)). In terms of other carcinogenicity classifications, this substance was classified as "D (Not classifiable as to human carcinogenicity)" in 1991 by EPA (IRIS Summary (Access on August 2015)), and as "A4" in 1996 by ACGIH. From the above, it was classified as "Classification not possible" for this hazard class.
Because the GHS Classification Guidance for the Japanese Government as the reference was changed, the classification result was changed from the previous one (Not classified).
7 Reproductive toxicity Classification not possible
-
-
- - There is no information on the reproductive toxicity in humans. As for experimental animals, in a two-generation reproduction toxicity study with rats dosed in an inhalation route, at up to doses (150, 400 ppm) where general toxicity effects (reduced body weight gain, increased liver and kidney weights, hepatocellular hypertrophy, etc.) were produced in the parental animals of the F0 and F1 generations, no effects on fertility and the next generation were observed in both generations (SIDS (2004), ATSDR (2006)). As for developmental toxicity, as a result of inhalation exposure at up to 400 ppm in pregnant rats and pregnant rabbits during the organogenesis period (rats: gestational days 6-15, rabbits: gestational days 6-18), at doses where maternal toxicity (reduced body weight gain) was observed, as developmental effects in fetuses, only a skeletal variation (delayed ossification of cervical vertebrae) was observed in rat fetuses, and no abnormality was observed in the rabbit fetuses (SIDS (2004), Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2006)). In addition, pregnant rats were dosed by gavage at up to 200 mg/kg/day during the organogenesis period (gestational days 6-15), but no adverse effects were observed in either maternal animals or fetuses (SIDS (2004), Hazard Assessment Report (CERI, NITE, 2008), ATSDR (2006)).
As in the above, there was no finding that clearly showed reproductive and developmental toxicity in experimental animals. However, as noted by the ATSDR, the developmental toxicity tests by the inhalation and oral routes were insufficiently described and provided a limited test result (ATSDR (2006)). Therefore, it was thought that there was a limitation to use it for classification from the viewpoint of reliability. Meanwhile, there is a description that dose-dependent morphological abnormalities were reported in the head, acrosome, and tail of sperm in a test in which male rats were given a single intraperitoneal dose at doses 50-800 mg/kg (ACGIH (7th, 2001), SIDS (2004)). Taken together, it was concluded that there was insufficient data to classify this substance as "Not classified" at the present time. Therefore, this substance was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Category 1 (liver, kidney), Category 3 (respiratory tract irritation, narcotic effects)



Danger
Warning
H370
H335
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
This substance is a respiratory tract irritant (Hazard Assessment Report (CERI, NITE, 2008), OEL Documentations (Japan Society For Occupational Health (JSOH), 1994), ACGIH (7th, 2001), NICNAS (2001), Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002), DFGOT Vol. 1 (1990), IARC 73 (1999), ATSDR (2006), SIDS (2004)). In humans, there are reports of narcotic effects and fatal paralysis by inhalation exposure at high concentrations, and vomiting, diarrhea, toxic hepatitis, and nephritis by ingestion (Hazard Assessment Report (CERI, NITE, 2008), OEL Documentations (Japan Society For Occupational Health (JSOH), 1994), ACGIH (7th, 2001), NICNAS (2001), Environmental Risk Assessment for Chemical Substances Vol. 1 (Ministry of the Environment, 2002)).
As for experimental animals, in inhalation exposure with rats and mice, weakness, centrilobular hepatocellular necrosis, and kidney tubule damage at doses corresponding to Category 1 (surviving individual), and narcotic effects at higher concentrations were observed (Hazard Assessment Report (CERI, NITE, 2008), OEL Documentations (Japan Society For Occupational Health (JSOH), 1994), ACGIH (7th, 2001), NICNAS (2001), DFGOT Vol. 1 (1990), IARC 73 (1999), ATSDR (2006)). In oral doses with rats and mice, centrilobular hepatocellular hypertrophy, hepatocellular vacuolar degeneration, and an increase in hepatocellular proliferation with hepatocellular necrosis at doses corresponding to Category 1, and lateral position, decreased locomotor activity, closed eyelid, gait disturbance, tremors, irregular respiration, and centrilobular hepatocellular hypertrophy at doses corresponding to Category 2 were observed (SIDS (2004), DFGOT Vol. 20 (2003), NICNAS (2001), JECDB (Access on August 2015)). The finding of tremors in experimental animals was included in a narcotic effect.
From the above, this substance has effects such as respiratory tract irritation, narcotic effects, and effects on the liver and kidneys. Therefore, it was classified in Category 1 (liver, kidney), Category 3 (respiratory tract irritation, narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system, liver, respiratory organs, haemal system)


Danger
H372 P260
P264
P270
P314
P501
In humans, polyneuropathy, liver damage, irritation to the nasal cavity and respiratory tract (Hazard Assessment Report (CERI, NITE, 2008)), bone marrow hyperplasia, acute haemolytic anaemia, leukocytosis (NICNAS (2001)), etc. were seen.
As for experimental animals, there is a report that in a 90-day oral toxicity test with rats dosed by gavage, centrilobular hepatocellular hypertrophy and centrilobular single cell necrosis (males) in the liver, and eosinophilic intracytoplasmic inclusion bodies in the proximal tubules of the kidney (males) were observed at or above 100 mg/kg/day (converted guidance value: 31.1 mg/kg/day), which is within the range of Category 2 (JECDB (Access on August 2015)). There is a report that in a 2-generation reproductive toxicity study with rats by the inhalation route, liver hypertrophy and effects on the kidneys (dilated renal tubules with intraluminal granular casts, intracytoplasmic granules/droplets in the proximal convoluted tubular epithelium) (males) were observed at or above 150 ppm (converted guidance value: 0.90 mg/L), which is within the range of Category 2 (SIDS (2004)). There is a report that in a 192-day inhalation toxicity study with rats, pneumonia was observed at 0.02 mg/L, which is within the range of Category 1 (Hazard Assessment Report (CERI, NITE, 2008)).
As in the above, in humans, effects were seen in the nervous system, liver, respiratory organs, and haemal system. In experimental animals, effects were seen in the lungs within a guidance value range corresponding to Category 1, and in the liver and kidneys within a guidance value range corresponding to the Category 2. The kidney was not adopted as a target organ since the effects on the kidneys were considered to be specific to male rats.
Therefore, this substance was classified in Category 1 (nervous system, liver, respiratory organs, haemal system).
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, the kinematic viscosity is calculated to be 1.014 mm2/sec (25/20 deg C) from the numerical data (viscosity: 1.324 mPa*s (25 deg C), density: 1.3059 g/mL (20 deg C)) listed on the HSDB (Access on August 2015).

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 = 0.66 mg/L for crustacea (Ceriodaphnia dubia) (NICNAS, 2001, Initial Risk Assessment (NITE, CERI, NEDO, 2007)), 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 (a degradation rate by 28-day BOD = 0%, a degradation rate by GC = 3% (Official Bulletin of Ministry of International Trade and Industry, 1975)), and 21-day NOEC (reproduction) < 0.10 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, 2007)).
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 and 96-hour LC50 = 1.16 mg/L for fish (Oncorhynchus mykiss) (SIDS, 2004).
By drawing a comparison between the above results, 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