GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 78-42-2 |
| Chemical Name | Tris(2-ethylhexyl) phosphate |
| Substance ID | H28-B-16-METI, M-008B |
| Classification year (FY) | FY2016 |
| Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI)/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 |
| 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 |
- |
- | - | Based on a flash point of 207 deg C (closed-cup) written in HSDB (Access on October 2016), 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 estimated that it does not ignite at normal temperatures from an autoignition temperature of 370 deg C (ICSC (1997)). |
| 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 |
- |
- | - | There is a metalloid (P) present in the molecule, but due to the water solubility data of 0.6 mg/L (HSDB (Access on October 2016)), it is estimated that it does not react vigorously with water. |
| 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, but 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. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - |
Based on a reported LD50 value (OECD TG 401) of > 2,000 mg/kg (JECDB (Access on October 2016)) for rats, this substance was classified as "Not classified." Besides, in the previous classification, LD50 values of 37,000 mg/kg, >10,000 mg/kg and >36,800 mg/kg (EHC 218 (2000)) for rats were used as the rationale for classification. However, since an LD50 value was obtained in an OECD TG 401 study, which has a higher priority according to the workflow of the GHS Classification Guidance, this value was used for the classification. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on the LD50 value of 18,400 mg/kg (Hazard Assessment Report (CERI, NITE, 2005), BUA 172 (1995)) for rabbits, this substance was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. There is a report that the LC50 (3.5 hours) value of rats is > 447 mg/m3 (converted 4-hour equivalent value: > 0.39 mg/L) (EHC 218 (2000), Hazard Assessment Report (CERI, NITE, 2005), BUA 172 (1995)), but this substance was classified as "Not classified" because it is difficult to specify the category from only these values. Besides, since the LC50 value is higher than the saturated vapor pressure concentration (0.00194 microg/L), the reference value as mist was applied. |
| 2 | Skin corrosion/irritation | Category 2 |
 Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
It is described that in a skin irritation test (OECD TG 404) using rabbits, well-defined erythema, slight to moderate oedema, crust formation and desquamation were observed; PII (primary irritation index) was 4.2/8.0; and therefore, this substance is a moderate irritant to rabbit skin (Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000)). From the above, this substance was classified in Category 2. |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - |
It is described that in an eye irritation test (OECD TG 405) using rabbits, this substance did not indicate irritation (Hazard Assessment Report (CERI, NITE) (2005)). In addition, it is reported that in the eye irritation test using rabbits, moderate conjunctivitis was observed when this substance was applied but was cleared after 24 hours (Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000)). Based on the result of a test conducted according to an OECD test guideline, this substance was judged as "Not classified." By adding data, the category was changed. |
| 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. Besides, there is a report stating negative in a test using guinea pigs (Hazard Assessment Report (CERI, NITE, 2005)), and there is a report stating weakly positive in a Landsteiner test using guinea pigs (Hazard Assessment Report (CERI, NITE, 2005)). However, it was judged that both data are insufficient to be used for the classification as the details are unknown. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - |
The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. As for in vivo tests, micronucleus tests using mouse bone marrow cells and peripheral blood erythrocytes were negative, a micronucleus test using rats was negative, a chromosomal aberration test using mouse bone marrow cells was negative, a sister chromatid exchange test using mouse bone marrow cells was positive and an unscheduled DNA synthesis test using mouse liver was negative (NTP DB (Access on October 2016), EHC 218 (2000), Hazard Assessment Report (CERI, NITE, 2005)). As for in vitro, a bacterial reverse mutation test, a mouse lymphoma assay, a chromosomal aberration test and a sister chromatid exchange test using cultured mammalian cells were negative (NTP DB (Access on October 2016), ECETOC JACC (1992), JECDB (Access on October 2016), Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - |
In a carcinogenicity study in which rats or mice were administered by gavage for 2 years, in the male rats, an increase in the incidence of pheochromocytoma of the adrenal glands was observed. However, it was pointed out that the incidence in the controls was low compared with the background data, thus it was judged as equivocal evidence of carcinogenicity (NTP TR274 (1984), Hazard Assessment Report (CERI, NITE, 2005)). On the other hand, in female mice, a significant increase in the incidence of hepatocellular carcinoma was observed; it was concluded that there was some evidence of carcinogenicity. In addition, there was no evidence of carcinogenicity in female rats and male mice (NTP TR274 (1984), Hazard Assessment Report (CERI, NITE, 2005)). As described above, there is no clear evidence of carcinogenicity in the experimental animals, and there are also no classifications by other organizations. Therefore, classification is not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. There is no single exposure data of this substance in humans. As for experimental animals, it is reported that in a single oral dose study using rats, there were no death cases at 2,000 mg/kg; and no changes suggesting toxic effects observed either, in terms of general conditions, changes in body weight and necropsy findings (JECDB (Access on November 2016)). In addition, it is reported that in a 3.5-hour single inhalation exposure study using rats at 460 mg/m3 of this substance, there were no death cases (EHC 218 (2000), ECETOC JACC (1982), Hazard Assessment Report (CERI, NITE, 2005)). Because there is no other information providing the rationale for the classification, this substance was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government. |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
There is no information in humans. As for experimental animals, multiple repeated dose toxicity studies using rats or mice dosed by gavage were conducted. Of these studies, it has been reported that in a 13-week study using mice, inflammatory lesions in the gastric mucosa, etc. are observed at the doses equal to or above 500 mg/kg/day (converted guidance value: 361 mg/kg/day), which is above Category 2 (NTP TR274 (1984), Hazard Assessment Report (CERI, NITE, 2005)), and that in a 103-week study using mice, increased thyroid follicular cell hyperplasia is reported at the doses equal to or above 500 mg/kg/day), which is above Category 2 (NTP TR274 (1984), Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000), ECETOC JACC (1992)). Moreover, 3-month inhalation toxicity studies using guinea pigs, dogs and rhesus macaques were conducted (Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000), ECETOC JACC (1992)). Of these studies, it is reported that in the study using dogs, moderate chronic inflammatory changes in the lung parenchyma and a significant dose-dependent deterioration in conditioned avoidance performance were observed. However, since this study used hybrid dogs and the number of animals used was as small as one of each sex, it is not possible to be used for classification. Therefore, this substance was classified as "Classification not possible." |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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 = 0.13 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011), Hazard Assessment Report (CERI, NITE, 2005)), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
Reliable chronic toxicity data were not obtained. Because it is not rapidly degradable (a degradation rate by BOD: 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1985)), and it is classified in Category 1 for acute toxicity, it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |