GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 25155-23-1
Chemical Name Tris(dimethylphenyl) phosphate
Substance ID H30-B-028-MHLW, MOE
Classification year (FY) FY2018
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 (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 Not classified
-
-
- - From a flash point of > 245 deg C [Open Cup] (HSDB (2018)) it is estimated to be above 93 deg C also in prescribed closed-cup methods, therefore, it was classified as "Not classified."
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 described in HSDB (2018) that it is not self-igniting.
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 classified
-
-
- - It contains a metalloid (P). However, because measured data of water solubility: 0.89 ppm (25 deg C) (HSDB (2018)) were obtained, it is estimated that it does not react vigorously with water.
13 Oxidizing liquids Classification not possible
-
-
- - It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (P). However, the classification is not possible due to no data.
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) Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats: >20,000 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007))
(2) LD50 for rats: >5,000 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), REACH registration dossier (Accessed Oct. 2018))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rabbits: >2,000 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), REACH registration dossier (Accessed Oct. 2018))
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - [Rationale for the Classification]
Liquid (GHS definition)
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) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified" (Category 3 in UN GHS classification).

[Evidence Data]
(1) There is a report that in a skin irritation test (Draize method, n=6, 4-hour semi-occlusive application) with rabbits, slight erythema was observed in 6/6 animals after 24 hours and was observed in 2/6 animals even after 72 hours (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), REACH registration dossier (Accessed Oct. 2018)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
[Rationale for the Classification]
Based on (1), it was classified in Category 2B.

[Evidence Data]
(1) There is a report that in an eye irritation test (Draize method, n=9) with rabbits, slight to moderate irritation was observed in the conjunctiva 1 hour after application but resolved in 24 hours (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), REACH registration dossier (Accessed Oct. 2018)).
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]
Classification not possible due to lack of data.
5 Germ cell mutagenicity Classification not possible
-
-
- - [Rationale for the Classification]
There are no in vivo data. Therefore, classification was not possible due to lack of data.

[Evidence Data]
(1) As for in vitro, there are reports that it was negative in bacterial reverse mutation tests (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Since it is considered from data in (1) and (2) that in parental animals in a reproductive toxicity test with rats, pregnancy could not be established due to decreased male fertility at the doses where general toxic effects rarely occurred, it was classified in Category 1B according to the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG422) with rats dosed by gavage, a decrease in the pregnancy rate was observed at or above 200 mg/kg/day, among the mated females, the number of successful pregnancies and deliveries were 2/11 animals at 200 mg/kg/day and 0/10 animals at 1,000 mg/kg/day. From the examination of the uterus contents, it was confirmed that the decrease in pregnancy rate was due to a decrease in fertility rate, not post-implantation embryonic loss. Males in the 1,000 mg/kg/day group were mated with untreated females after a recovery period following completion of treatment. Since pregnancy and delivery were established normally, reduced male fertility was found to be a reversible effect (Proposal for identification of SVHC (2013), REACH registration dossier (Accessed Oct. 2018)).
(2) As for general toxic effects at doses where effects on reproductive toxicity in (1) were observed, only transient effects of low value of food consumption and reduced body weight gain in males at 1,000 mg/kg/day in Week 1 of administration, and low food consumption and reduced body weight gain in females at or above 200 mg/kg/day in the latter half of pregnancy period were observed. However, this is considered to be due to the unsuccessful pregnancy (REACH registration dossier (Accessed Oct. 2018)).

[Reference Data, etc.]
(3) EU first classified it as "Repr. 1B" based on the above data and then proposed it as a candidate SVHC (Proposal for identification of SVHC (2013)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data. Besides, based on the data in (1), in a test with chickens sensitive to neurotoxicity, neurotoxic effects were detected, but they are effects exceeding the range of Category 2.

[Reference Data, etc.]
(1) As for experimental animals, in 3 studies of a single oral dose with chickens at 11.4-15,000 mg/kg of this substance, a significant reduction of cholinesterase activities in the plasma and brain at doses of 114 mg/kg or above and evidence of delayed neurotoxicity (ataxia and histopathological changes in the nerves) at doses of 10,000 mg/kg or above were observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)).
9 Specific target organ toxicity - Repeated exposure Category 2 (genetic organs (women))


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1), due to effects on the male adrenal glands and the male genetic organs within the range of Category 1, and effects on the female genetic organs within the range of Category 2, it was classified in Category 1 (genetic organs (men), adrenal glands), Category 2 (genetic organs (women)). Besides, since tissue changes in the liver (female only) were considered to be effects at doses exceeding the range of Category 2, the liver was not adopted as the target organ.

[Evidence Data]
(1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage for 33 days or more in males and 48 days or more in females, at or above 25 mg/kg/day (converted guidance value (male/female): at or above 9.2/13.3 mg/kg/day), which is within the range of Category 1 in males and within the range of category 2 in females, effects on the male and female genetic organs (degeneration of the germinal epithelium of the testis, sloughed epithelial cells in the lumen of the epididymis, slight diffuse hyperplasia of the interstitial cells of the ovary), effects on the adrenal glands (increased weight (females (medium and higher doses in male)), diffuse cytoplasmic vacuolation (males (medium or higher doses in females))) were observed. In addition, at or above 200 mg/kg/day of the medium dose (converted guidance value (male/female): at or above 73.3/106.7 mg/kg/day), which is within the range of Category 2 in males and is exceeding the range of Category 2 in females, effects on the liver (increased weight, slight fatty degeneration of hepatocytes (females)) were observed (Proposal for identification of SVHC (2013), REACH registration dossier (Accessed Oct. 2018)).
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 (Acute) Not classified
-
-
- - Despite 96-hour LC50 > 0.020 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, 2018)), because water solubility is 0.89 mg/L (25 deg C, PHYSPROP Database: 2018), and all the reliable toxicity data are above water solubility, it was classified as "Not classified."
11 Hazardous to the aquatic environment (Long-term) Category 2


-
H411 P273
P391
P501
It was classified in Category 2 because it is not rapidly degradable (not readily degradable, an average degradation rate by BOD: 0% (J-CHECK, 2001)), and due to 21-day NOEC (reproduction inhibition) = 0.17 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2018), Environmental Risk Assessment for Chemical Substances Vol. 3 (Ministry of the Environment, 2004), Initial Risk Assessment (NITE, CERI, NEDO, 2007)).
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


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.

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