Latest GHS Classification Results by the Japanese Government (edited by NITE)

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 78-87-5
Chemical Name 1,2-Dichloropropane
Substance ID m-nite-78-87-5_v1
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) To Guidance List
UN GHS document (External link) To UN GHS document
FAQ(GHS classification results by the Japanese Government) To FAQ
List of Information Sources (Excel file) List of Information Sources
List of Definitions/Abbreviations Definitions/Abbreviations
Sample Label by MHLW (External link) MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) To OECD/eChemPortal (External link)

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecules. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
6 Flammable liquids Category 2


Danger
H225 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
Its flash point is 16degC (closed cup) according to the ICSC (2000) and its boiling point is 96degC. Based on this information, the substance falls under Category 2. It is rated as Class 3 and packing group II by the UNRTDG (UN No. 1279). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
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. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
9 Pyrophoric liquids Not classified
-
-
- - It does not spontaneously ignite in contact with the air at room temperature (autoignition point: 557degC (ICSC, 2000)). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid substances are not available. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
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). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Organic compounds containing chlorine (but not oxygen or fluorine), which is chemically bonded only to carbon or hydrogen. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
16 Corrosive to metals Classification not possible
-
-
- - No data available. It is rate as Class 3 by the UNRTDG (UN No. 1279). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
17 Desensitized explosives -
-
-
- - - - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Acute toxicity (Oral) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
Based on the oral LD50 of 1900 mg/kg for the rat (EHC 146 (1993)), the substance was classified into Category 4. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on the dermal LD50 of 10115 mg/kg for the rabbit (DFGOT vol. 9 (1998)), the substance was classified into the "Not classified" category. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - It was classified into the "Not applicable" category since it is a liquid (GHS definition), and it is presumably not inhalable as a gas. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
1 Acute toxicity (Inhalation: Vapours) Not classified
-
-
- - The 10-hour LC50 of 14 mg/L for rats obtained in vapour inhalation exposure test (PATTY 5th (2001)) is converted to 4-hour LC50 of 35 mg/L (7600 ppm).
Given that its saturated vapour pressure is 7.1 kPa at 25degC (HSDB (2005)), its saturated vapour pressure concentration is 70000 ppm. As the LC50 value obtained above is lower than 90% of the saturated vapour pressure concentration, the test was presumably conducted in a vapour with almost no included mists. Under this condition, the substance was classified into the "Not classified" category using the ppm concentration criteria.
FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - No data available. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
The substance was classified into Category 2 since it was considered to be irritating based on the results of the skin irritation test using rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 39 (2005)) and the report on the effect of the substance on humans (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 2 (2003)). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
The substance was classified into Category 2A since it was considered to be a reversible and moderate irritant based on the results of the eye irritation test using rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 39 (2005)) and the report on the effect of the substance on humans (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 2, 2003; Patty, 1995). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
4 Respiratory sensitization Classification not possible
-
-
- - No data available. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
4 Skin sensitization Category 1


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
The substance was classified into Category 1 since it is considered to be a skin sensitizer based on the report on two human cases (EHC 146 (1993)). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
5 Germ cell mutagenicity Not classified
-
-
- - It was classified into the "Not classified" category since heritable mutagenicity test (dominant lethal test using rats) gave negative results according to Initial Risk Assessment Report (NITE, CERI, NEDO) No. 39 (2005). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
6 Carcinogenicity Category 1A


Danger
H350 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Because sufficient evidence of carcinogenicity was observed in humans ((1), (2)), it was classified in Category 1A.
By using information published after the previous classification, the category was revised.

[Evidence Data]
(1) Out of 62 workers who had worked in a printing plant for one year or longer, at least 11 developed cholangiocarcinoma inside or outside of the liver, and six of them died. Estimated exposure concentrations of this substance were 100-670 ppm, and estimated exposure duration was 7-17 years. Ten of them had also been exposed to dichloromethane (estimated exposure concentrations: 80-540 ppm, exposure duration: 1-13 years). Moreover, in a report of two workers who had worked in other facilities and developed cholangiocarcinoma, and in a report of six workers who had worked in three different facilities and developed cholangiocarcinoma, many of them had been simultaneously exposed to dichloromethane and chlorine compounds other than this substance, and all of them had been exposed to this substance at concentrations higher than other chemicals. Therefore, it is reported that this substance plays an important role in onset of cholangiocarcinoma (OEL Documentations (Carcinogenicity classification) (Japan Society For Occupational Health (JSOH), 2014))
(2) IARC analyzed case reports of cholangiocarcinoma in printing plants in Japan and concluded that there is sufficient evidence for the carcinogenicity of this substance in humans (IARC 110 (2017)).
(3) As for classification results by domestic and international organizations, it was classified in Group 1 by IARC (IARC 110 (2017)), Carc. 1B by EU CLP (EU CLP), and Group 1 by Japan Society for Occupational Health (JSOH) (OEL Documentations (Japan Society For Occupational Health, 2017): proposed in 2014). EU adopted (5) Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) in Japan, but it regarded the result (1) to be limited. Moreover, ACGIH classified it in A4 (ACGIH (7th, 2014)), but either (5) or (1) is not included in its evaluation.

[Reference Data, etc.]
(4) In a test in which rats and mice were dosed by gavage for 103 weeks, a significant increase in hepatocellular adenoma and carcinoma (combined) was observed in male mice of the high dose group (250 mg/kg) and female mice of the low and high dose groups (125, 250 mg/kg) (NTP TR263 (1986)).
(5) In a test in which rats or mice were given 104-week inhalation exposure, 6 hours/day, 5 days/week, in rats, an increased incidence of squamous cell papilloma of the nasal cavity was found in both males and females at 500 ppm, and in mice, increased incidences of Harderian gland adenoma (males) and bronchiolar alveolar adenoma and carcinoma (combined) (females) were observed at 200 ppm (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2005)).
(6) Based on Appended Table 1-2, (iv) 1 of the Ordinance for Enforcement of the Labor Standards Act, cholangiocarcinoma due to work involving exposure to this substance is included in Disease designated by the Minister of Health, Labour and Welfare due to work involving exposure to simple chemical substances or compounds (including alloys) designated by the Minister of Health, Labour and Welfare. Moreover, based on paragraph (3) of Article 28 of the Industrial Safety and Health Act, it is subject to guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare (Based on paragraph (3) of Article 28 of the Industrial Safety and Health Act, this substance is subject to guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare (Public announcement on guidelines in order to prevent the impairment of worker's health, No. 23, Oct 10, 2012).
FY2018 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a 2-generation test using rats, decreased body weight in neonates at birth and increased mortality of neonates were noted at the concentrations that affected parental animals (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 39 (2005)). Based on these results, the substance was classified into Category 2. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
8 Specific target organ toxicity - Single exposure Category 1 (liver, blood, 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
Clinical signs of being exposed to this substance included shock, delirium, cardiovascular collapse, resulting death in 36 hours. Autopsy confirmed hepatic necrosis (ACGIH, 2006) and acute tubular necrosis (EHC 146 (1993)). Exposed people also experienced fatigue, possibly attributed to CNS depression (ATSDR (1989)). In animal experiments, respiratory tract irritation (ACGIH, 2006), labored breathing, hypomopbility, and coma were observed (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 39 (2005)). Based on these reports, the liver, blood system, and kidney were considered as target organs, and the substance was linked to respiratory tract irritation and narcotic effects. Overall, the substance was classified into Category 1 for the liver, blood system, and kidney, and Category 3 for respiratory tract irritation and narcotic effects. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
9 Specific target organ toxicity - Repeated exposure Category 1 (kidney, liver, blood system), Category 2 (respiratory organs)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
The substance is associated with hemolytic anemia and dysfunction of the liver and kidney in humans (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 39 (2005), ACGIH, 2006). In animal studies, the kidney, liver, blood system, and respiratory system were considered to be target organs based on the report that the substance is related to degeneration of the olfactory epithelium (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 39 (2005)). Based on these reports, the kidney, liver, blood system, and respiratory system were considered to be the target organs. In animal studies, these effects were observed at Category 2 guidance doses.
In conclusion, the substance was classified into Category 1 for the kidney, liver, and blood system, and Category 2 for the respiratory system.
FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
10 Aspiration hazard Classification not possible
-
-
- - No data available. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
11 Hazardous to the aquatic environment Short term (Acute) Category 3
-
-
H402 P273
P501
It was classified into Category 3 from 48 hours EC50=13600microg/L of the crustacea (Ceriodaphnia) (MOE Risk Assessment vol. 2 (2003) and others.). FY2006 GHS Classification Manual (10 Feb, 2006)
11 Hazardous to the aquatic environment Long term (Chronic) Category 3
-
-
H412 P273
P501
Although acute toxicity was Category 3 and the potential was low (BCF=6.9(Existing Chemical Safety Inspections Data)), since there was no rapidly degrading (the decomposition by BOD: 0%(Existing Chemical Safety Inspections Data)), it was classified into Category 3. FY2006 GHS Classification Manual (10 Feb, 2006)
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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