GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 120-61-6 |
| Chemical Name | Dimethyl terephthalate |
| Substance ID | H27-B-09-METI/M-028B_P |
| Classification year (FY) | FY2015 |
| 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 |
- |
- | - | Solid (GHS definition). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition). |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 7 | Flammable solids | Classification not possible |
- |
- | - | It is combustible, but the classification is not possible due to no data. |
| 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 applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 518 deg C (ICSC (2004)). |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data 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 |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not 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 reports of LD50 values for rats of > 3,200 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), PATTY (6th, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), 4,390 mg/kg (SIDS (2005)), and > 6,590 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2005)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on a report of an LD50 value of > 5,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2005)) for guinea pigs, it was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there is a report of an LC50 value (2 hours) for rats of > 6.0 mg/L (converted 4-hour equivalent value: > 3.0 mg/L) (Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), SIDS (2005)), however, a category cannot be determined based on this data alone. Since the test substance is solid, the reference value of dust was applied. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | There are reports that in skin irritation tests with guinea pigs or mice, slight irritation was observed (SIDS (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). As for humans, there is a report that no irritation was observed in the test in which this substance (80%) was applied 10 times, and dermatitis, etc. by exposure to the dust of this substance, etc. were reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, it was classified as "Not classified" (Category 3 in UN GHS classification). |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
There are reports that in eye irritation tests with rabbits, slight irritation was observed or no irritation was observed (SIDS (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, there is a description that exposure to this substance causes redness in the eyes (Environmental Risk Assessment for Chemical Substances Vol.3, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2004)). From the above, it was classified in Category 2B based on the report of slight irritation. |
| 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 are multiple reports of negative results in skin sensitization tests with guinea pigs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2005), PATTY (6th, 2012)), but these data were judged as insufficient for use in the classification since the details such as the test method are unknown. Since data in the previous classification is from the information source in List 3, it was deleted, and the category was reviewed. |
| 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, micronucleus tests with bone marrow cells and peripheral blood lymphocytes of mice were negative, chromosomal aberration tests and a sister chromatid exchange test with mouse bone marrow cells were equivocal (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), SIDS (2005), NTP DB (Access on November 2015)). As for in vitro, bacterial reverse mutation tests, and a mouse lymphoma test, chromosomal aberration tests, micronucleus tests and a sister chromatid exchange test with mammalian cultured cells were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), SIDS (2005), NTP DB (Access on November 2015)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | There is no information on carcinogenicity in humans. As for experimental animals, there are reports of 2-year carcinogenicity studies with rats or mice dosed in the oral route. In rats, no increase in incidence of tumors was observed at up to 5,000 ppm in both sexes. On the other hand, in the test with mice, increases in incidence of adenomas of alveolar/bronchiolar epithelium, and in combined incidence of adenomas and carcinomas of alveolar/bronchiolar epithelium were observed in males, but no increase in incidence of tumors associated with exposure to this substance, including lung tumors, was observed in female mice. There was no significant effect on survival rate and body weight in the administration group in the tests on either rats or mice. Although the possibility cannot be denied that the dose was inadequate, it is concluded in NTP that there was no development of tumors clearly associated with the administration of this substance in both females and males of rats and mice under the conditions of these tests (NTP TR 121 (1977), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), PATTY (6th, 2012)). On the other hand, it is concluded in SIDS that there were no increases in incidence of tumors in rats of either sex and female mice, but development of lung tumors in male mice was considered equivocal (SIDS (2005)). There are no classification results by other organizations. From the above, although the test results on experimental animals tend to deny the tumorigenic potential of this substance, it is considered that there is a possibility that the dose may be insufficient as described in NTP, and there is no information on carcinogenicity in routes other than the oral route. Therefore, classification was not possible due to lack of data for this hazard class. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | There is no information on reproductive effects in humans. As for experimental animals, in a one-generation reproductive toxicity test in which this substance was orally administered (feeding) to male rats for 115 days before mating and to females for 6 days before mating, and females after mating continued to be dosed through pregnancy and lactation periods, no toxic effect was found in parental animals, but a low value of body weight was observed at or above 5,000 ppm in the pups (SIDS (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 20008), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), PATTY (6th, 2012)). As for developmental toxicity tests, there is a report that in a test in which 1000 mg/kg/day of this substance was administered by gavage to pregnant rats on gestational days 7-16, maternal toxicity, developmental toxicity in the fetuses and embryonic loss before and after implantation were not observed (SIDS (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). There is a report that also in a test in which pregnant rats were exposed by inhalation of this substance at a concentration of 1 mg/m3 through pregnancy period, similarly, abnormality was not observed in the maternal animals and fetuses (SIDS (2005), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012)). From the above, clear reproductive and developmental effects were not detected from the results of the one-generation reproductive test and developmental toxicity test with rats, and the result in the oral route may be equivalent to "Not classified." However, to make the classification conclusive, it is desirable that nontoxic results are obtained in a multi-generation reproductive toxicity test of 2 generations or more which is compliant with the guideline, and additionally, it is difficult to say that the dose of the developmental toxicity test by the inhalation route is sufficient. Therefore, classification was not possible due to lack of data for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (Respiratory tract irritation) |
 Warning |
H335 | P304+P340 P403+P233 P261 P271 P312 P405 P501 |
As for humans, irritation of the respiratory organs by the vapor or dust of this substance is reported (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). As for experimental animals, by an inhalation exposure to the high-temperature vapor of the substance (LC50 > 6 mg/L) in rats, irritation of the respiratory organs, mucosal hyperaemia, irregular respiration and cyanosis were reported (SIDS (2005)). However, it was not adopted as the target of classification because it was an old finding, and the details were unknown. From the above, it was classified in Category 3 (respiratory tract irritation). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | No information on humans is available. As for experimental animals, no finding corresponding to specific target organ toxicity was observed in the range of Category 2 in the oral route. Besides, as a characteristic finding at a dose exceeding the range of Category 2, it is reported that urinary bladder calculi occurred in multiple tests with rats (SIDS (2005), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). As for the inhalation route, in a 3-month inhalation toxicity test with rats, in the inhalation group of 86.4 mg/m3 (4 hours/day, 58-time exposure, converted guidance value: 0.037 mg/L/6 hr/day) of dust, which is within the guidance value range for Category 2, increases in nose rubbing behavior, face washing behavior, and blinking were observed (SIDS (2005), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances Vol.10 (Ministry of the Environment, 2012), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), but it is considered that they are not findings corresponding to specific target organ toxicity. From the above, in the oral and inhalation routes, there are no findings corresponding to specific target organ toxicity. Besides, the information cited in the previous classification was confirmed, and there are no descriptions of the frequency of exposure, the state of the test substance at the time of exposure, etc., and the details of the study report were unknown, so it was not used for the classification. Therefore, it was classified as "Classification not possible" due to lack of data. |
| 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 2 |
- |
H401 | P273 P501 |
From 96-hour LC50 = 9.6 mg/L for fish (Pimephales promelas) (SIDS, 2005, Initial Risk Assessment (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances vol. 10 (Ministry of the Environment, 2012)), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | If chronic toxicity data are used, then it is classified as "Not classified" due to being rapidly degradable (readily biodegradable: a degradation rate by 14-day BOD = 84%, a degradation rate by HPLC = 100% (Official Bulletin of Ministry of International Trade and Industry, 1980)), 72-hour NOEC (r) = 5.27 mg/L for algae (Desmodesmus subspicatus) (Environmental Risk Assessment for Chemical Substances vol. 10 (Ministry of the Environment, 2012)), and 21-day NOEC (reproduction) = 1.72 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances vol. 10 (Ministry of the Environment, 2012)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to rapid degradability and a low bioaccumulation estimate (log Kow= 2.25 (PHYSPROP Database, 2009)) although 96-hour LC50 = 9.6 mg/L for fish (Pimephales promelas) (SIDS, 2005, Initial Risk Assessment (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances vol. 10 (Ministry of the Environment, 2012)). From the above results, it was classified as "Not classified." |
| 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. |