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

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GENERAL INFORMATION
 
Item Information
CAS RN 13674-87-8
Chemical Name Tris(dichloropropyl) phosphate
Substance ID m-nite-13674-87-8_v2
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 molecule. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
6 Flammable liquids Not classified
-
-
- - The flash point 252 degC (Cleveland open cup) was obtained (HSDB (2003)), and it is estimated that the flash point measured by the closed-cup method is >= 93 degC. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
8 Self-reactive substances and mixtures Not classified (Not applicable)
-
-
- - Although it contains P-O, this substance is phosphate and not phosphite (phosphorous acid) (- P-(-O-) 3). Therefore this substance is classified as "Not applicable" because there are no chemical groups present in the molecule associated with explosive or self-reactive properties. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
9 Pyrophoric liquids Classification not possible
-
-
- - No data available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid substances are not available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- - Although it contains a metalloid (P), its water solubility is 18.1 mg/L (SIAP (2009)) and it is considered that doesn't react strongly with water. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
13 Oxidizing liquids Classification not possible
-
-
- - The substance is an organic compound containing oxygen which is chemically bonded to the element other than carbon or hydrogen. Since no test results for oxidizing property are available, classification is not possible. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
16 Corrosive to metals Classification not possible
-
-
- - No data available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
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) Not classified
-
-
- - Based on the rat LD50 values of 2236 mg/kg (male), 2359 mg/kg (female) and > 2000 mg/kg bw (OECD TG 401, GLP-compliant) (EU-RAR (2008)), the substance was classified as "Not classified" in the JIS classification (corresponding to Category 5 in the UN-GHS classification). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on the report (EU-RAR (2008)) that the rat LD50 value was > 2000 mg/kg bw and the administration of 2000 mg/kg caused no mortality (OECD TG 402, GLP-compliant), the substance was classified as "Not classified". FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - Liquid (GHS definition) FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
1 Acute toxicity (Inhalation: Dusts and mists) Not classified
-
-
- - Based on the report (EU-RAR (2008)) that the rat LC50 value was > 5.22 mg/L/4hrs and the exposure of 5.22 mg/L caused no mortality (OECD TG 403, GLP-compliant), the substance was classified as "Not classified". As the exposure concentration of 5.22 mg/L was higher than saturated vapor pressure concentration of 0.00000171 mg/L, the criterion values for mist were adopted. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
2 Skin corrosion/irritation Not classified
-
-
- - In the rabbit test (OECD TG404, GLP-compliant) that 0.5 ml of test substance was instilled to 3 rabbits for 4 hours with semi-occlusive conditions, erythema (grade 2) was recorded in 2/3 animals after one hour and persisted for 24 hours in one animal. Erythema (grade 1) was noted in the third animal. There was no edema. All reactions disappeared within 48 hours (EU-RAR (2008)). Based on the document, the substance was classified as "Not classified". FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
3 Serious eye damage/eye irritation Not classified
-
-
- - In the rabbit test (OECD TG405, GLP-compliant), application of 0.5 mL of test substance caused slight conjunctival erythema in all animals after 1 hour. These recovered by 24 hours. There were no other effects of treatment. Based on the document, the substance was classified as "Not classified" (EU-RAR (2008)). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Respiratory sensitization Classification not possible
-
-
- - No data available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
4 Skin sensitization Not classified
-
-
- - The substance was classified as "Not classified" since in the guinea pig maximization tests (OECD TG 406, GLP-compliant), no skin sensitization was observed (EU-RAR (2008)). In addition, as the summary of the data obtained, there was a consideration that the substance was not a skin sensitizer (EU-RAR (2008)). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
5 Germ cell mutagenicity Not classified
-
-
- - The classification was concluded as "Not classified" based on the negative results in the micronucleus test using bone marrow cells obtained from mice orally administered (OECD TG474, GLP-compliant) as well as the chromosome aberration test using bone marrow cells obtained from mice orally administered (in vivo mutagenicity test in somatic cells) (EU-RAR (2008)). As relevant information, as for in vitro studies, positive results in the Ames test (EHC 209 (1998)), negative results in the chromosome aberration test using Chinese hamster CHO cells (OECD TG473, GLP-compliant) (EU-RAR (2008)), positive or false positive in the chromosome aberration test using mouse lymphoma L5178Y cells (EHC 209 (1998), EU-RAR (2008)), negative results in the chromosome aberration test using human fibroblast cells (EHC 209 (1998)), and negative or positive results in the gene mutation test using mouse lymphoma L5178Y cells (EHC 209 (1998), EU-RAR (2008)), were reported. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) to (3) and the latest classification result by the EU, it was classified in Category 2. It was classified based on the new information source.

[Evidence Data]
(1) As for the classification results by international organizations, based on (2) and (3), in the ECHA CLP classification result, this substance was classified in Carc. 2 (Accessed Oct. 2021: Proposed in 2010) as a non-genotoxic and threshold carcinogen.
(2) In a two-year oral toxicity test with rats dosed by feeding, an increase in the incidence of renal cortical tubular adenoma, and liver tumors (hepatocellular adenoma, carcinoma) were observed at or above 5 mg/kg/day, an increase in the incidence of testicular interstitial cell tumors (benign tumors) (males) was observed at or above 20 mg/kg/day, and an increase in the incidence of adrenal cortical adenoma (females) was observed at or above 80 mg/kg/day (EU RAR (2008), CLH Report (2009), SIAP (2009), AICIS IMAP (2018)).
(3) This substance has no genotoxicity positive evidence in vivo (CLH Report (2009), ECHA RAC Opinion (2010)).

[Reference Data, etc.]
(4) In a retrospective cohort study of 289 workers who were exposed to this substance while working at a manufacturing plant of this substance, ten workers died during the study period, and the overall mortality of the study population was 75% of that expected in a comparable population of US males. Three cases of lung cancer were observed, compared to 0.8 expected, however, all 3 workers were cigarette smokers, which may have confounded the diagnosed lung cancers, and it was concluded there was no evidence linking the exposure to this substance with lung cancers. In addition, the incidence of tumors in the liver, kidney, and testis was observed in experimental animals, but no cancer was observed at these sites in workers. However, as this was a small study, the study findings may not be highly reliable (AICIS IMAP (2018), EU RAR (2008), CLH Report (2009)).
FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7 Reproductive toxicity Not classified
-
-
- - In the developmental toxicity study using pregnant rats orally administered during the organogenetic period, maternal toxicity such as significant decrease in the body weight gain and food consumption was observed, and death occurred at the highest dose (400 mg/kg bw/day), and significant increase in the incidence of resorption and delayed ossification were also observed. There was no increase in the fetal death, and neither abnormality of the fetal growth nor malformation was seen in the dose of 200 mg/kg or less (SIAP (2009)). Increased resorption was not adopted as the basis of classification, because of the influence of only at high dose levels seen significant maternal toxicity containing deaths. In addition, in the oral administrated study in rabbits for 12 weeks, in addition to indices on mating, fertility and pregnancy, numbers of corpora lutea, implantations, viable fetuses or resorption were unaffected by treatment (EU-RAR (2008)). Thus, no adverse effects on sexual function and fertility were observed. Therefore, the substance was classified as "Not classified". FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - In the single dose oral toxicity study in rats (OECD TG401, GLP-compliant), in addition to occurrence of deaths, decreased respiratory rate, loss of righting reflex, vocalization were observed at 1710 mg/kg bw or higher (EU-RAR (2008)). In another single dose oral study in rats, deaths occurred at 2000 mg/kg with clinical signs of toxicity such as salivation, hypokinesia and ataxia (EU-RAR (2008)). The LD50 values of both studies were greater than 2000 mg/kg, clinical signs of toxicity were non-specific (EU-RAR (2008)). This document was not enough to adopt as the basis for classification due to lack of sufficient data, so the classification was determined as "Classification not possible". As relevant information, in the dermal application study in rats treated at 2000 mg/kg (OECD TG402, GLP-compliant), there were no mortalities and no clinical signs of toxicity, and no abnormality was detected at necropsy (EU-RAR (2008)). Similarly, in the single inhalation study in rats exposed at the concentration of 5.22 mg/L (OECD TG 403, GLP-compliant), there were no mortalities and no clinical signs of toxicity, and no abnormality was detected at necropsy (EU-RAR (2008)). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
9 Specific target organ toxicity - Repeated exposure Category 1 (kidney, testis)


Danger
H372 P260
P264
P270
P314
P501
In the 24-month feeding study in rats, increase in the incidence of hyperplasia of the convoluted tubule epithelium in the kidneys, and the effects on the testes containing atrophy of germinal epithelium, oligospermia, or atrophy of seminal vesicles were observed in males treated at the dose level of 5 mg/kg/day (equivalent to Category 1 of the guidance values) or more (EU-RAR (2008)). Based on the findings, the substance was classified as Category 1 (kidney, testis). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
10 Aspiration hazard Classification not possible
-
-
- - No data available. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)

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 2
-
-
H401 P273
P501
Classified into Category 2 from its 96h-LC50 = 1.1 mg/L for fish (Oncorhynchus mykiss) (EU-RAR, 2008). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
11 Hazardous to the aquatic environment Long term (Chronic) Category 2


-
H411 P273
P391
P501
Classified into Category 2 since its acute toxicity is Category 2 and it is not rapidly degradable (Non-biodegradable, BOD degradation rate: 1% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1980)). FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in Annexes to the Montreal Protocol. FY2010 GHS Classification Guidance by the Japanese Government (July, 2010)


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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