GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 11070-44-3 |
| Chemical Name | Tetrahydromethylphthalic anhydride [methyltetrahydroisobenzofuran-1,3-dione] |
| Substance ID | H27-B-006/C-027B_P |
| Classification year (FY) | FY2015 |
| 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 |
| 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 present in the molecule associated with explosive properties. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 6 | Flammable liquids | Not classified |
- |
- | - | Based on a flash point of 157 degrees C (open cup) and a boiling point of 290 degrees C (SIDS (2005)), it was classified as "Not classified." |
| 7 | Flammable solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | It contains an unsaturated bond (olefin) in the chemical structure, but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No established test method suitable for liquid substances. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an organic compound that does not contain bivalent -O-O- structure in the molecule. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 4 |
 Warning |
H302 | P301+P312 P264 P270 P330 P501 |
Three reported LD50 values for rats were 1,900 mg/kg (Result of the initial environmental risk assessment of chemicals, Vol. 4, Ministry of the Environment in Japan, Tentative hazard assessment sheet (2005); SIDS (2005)), > 2,000 mg/kg (in accordance with OECD TG401) (Japan Existing Chemical Data Base, Ministry of Health, Labour and Welfare (Access on June 2015); Result of the initial environmental risk assessment of chemicals, Vol. 4, Ministry of the Environment in Japan, Tentative hazard assessment sheet (2005); SIDS (2005)), and 1,900-2,590 mg/kg (Initial Risk Assessment, NITE (2008)). Because one corresponds to Category 4, and one corresponds to "Not classified," the substance was classified in Category 4 to which the lowest LD50 value corresponds. Besides, one was not included in a number due to being summary data. |
| 1 | Acute toxicity (Dermal) | Category 4 |
Warning |
H312 | P302+P352 P362+P364 P280 P312 P321 P501 |
From three reported LD50 values for rabbits of 1,710 mg/kg (SIDS (2005)), 1,710 mg/kg (Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2002)), and > 2,000 mg/kg (SIDS (2005)), it was classified in Category 4 to which most of the data correspond. Based on the information of SIDS (2005) and Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2002) obtained in this investigation, the classification was revised. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Liquids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 | P302+P352 P332+P313 P362+P364 P264 P280 P321 |
It was reported to be "moderately irritating" from PII (primary dermal irritation index) of 3.5 in a skin irritation test using rabbits (unknown application time) (SIDS (2005)). Moreover, in another report, an irritation index of 1 was reported after open application of 0.01 mL undiluted this substance to the abdomen of rabbits, but the details are unknown (SIDS (2005)). From the above results, the substance was classified in Category 2. |
| 3 | Serious eye damage/eye irritation | Category 1 |
 Danger |
H318 | P305+P351+P338 P280 P310 |
In an eye irritation test using rabbits, after application of 0.1 mL undiluted this substance, corneal opacity and opacification of eyeballs after one minute and congestion in iris after 24 hours were observed, and recovery was not complete after ten days (SIDS (2005)). Moreover, in another test, after application of 0.005 mL undiluted liquid or 0.5 mL of a 5% solution, the severe corneal damage was reported after 18-24 hours (SIDS (2005)). From the above results, because recovery was not found after ten days and severe corneal damage was reported, the substance was classified in Category 1. Besides, it is classified in "Eye Dam. 1 H318" in EU CLP classification (ECHA CL Inventory (Access on June 2015)). The classification was revised by reviewing information. |
| 4 | Respiratory sensitization | Category 1 |
 Danger |
H334 | P304+P340 P342+P311 P261 P284 P501 |
In multiple occupational exposure reports, effects by respiratory sensitization such as productive cough, wheezing, asthma, and coughing were reported (Initial Risk Assessment, NITE (2008); SIDS (2005); Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2002); Result of the initial environmental risk assessment of chemicals, Vol. 4, Ministry of the Environment in Japan (2005); DFGOT vol. 10 (1998)). Moreover, this substance is classified as a respiratory tract sensitizing substance, Group 1 by Japan Society for Occupational Health (Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2002)). From the above, the substance was classified in Category 1. Besides, it is classified in "Resp. Sens. 1 H334" in EU CLP classification (ECHA CL Inventory (Access on June 2015)). |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
In multiple occupational exposure reports, findings showing skin sensitization such as dermatitis and urticaria were reported (Initial Risk Assessment, NITE (2008); SIDS (2005); Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2002)). From the above results, it was classified in Category 1. Besides, this substance is classified in "Skin Sens. 1 H317" in EU CLP classification (ECHA CL Inventory (Access on June 2015)). |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. There are no in vivo data, and as for in vitro, a bacterial reverse mutation test was negative, and a chromosomal aberration test in cultured mammalian cells was equivocal. (Japan Existing Chemical Data Base, Ministry of Health, Labour and Welfare (Access on June 2015); Initial Risk Assessment, NITE (2008); SIDS (2005); Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2002)) |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a combined repeated dose toxicity study with reproduction/developmental toxicity screening test (OECD TG 422) using rats in an oral route (by gavage), toxic effects were not observed in fertility of parent animals and survival rate and body weight transition by day 4 after birth in offspring up to the highest dose of 300 mg/kg/day. (SIDS (2005); Tentative hazard assessment sheet, Ministry of the Environment in Japan (2005); Japan Existing Chemical Data Base, Ministry of Health, Labour and Welfare (Access on June 2015)) However, the classification as "Not classified" is not possible only with this result which is screening test result, and there are no other available data. Therefore, the substance was classified as "Classification not possible" due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (respiratory tract irritation, narcotic effects) |
Warning |
H335 H336 |
P304+P340 P403+P233 P261 P271 P312 P405 P501 |
This substance is irritating to the respiratory tract (SIDS (2005); Initial Risk Assessment, NITE (2008)). As for experimental animals, it is reported that in oral administration at 2,000 mg/kg in rats, decreased spontaneous motility, bradypnea, and prone position were observed but resolved within three days after administration (Japan Existing Chemical Data Base, Ministry of Health, Labour and Welfare (Access on June 2015)), and mucosal hypertrophy, squamous epithelial hyperplasia, and submucosal granulomatous inflammation of the forestomach caused by local irritation (no detailed description except LD50: 1,900 mg/kg) were reported (SIDS (2005); Initial Risk Assessment, NITE (2008)). Decreased spontaneous motility, bradypnea, and prone position mentioned above were regarded as signs of narcotic effects. Moreover, because mucosal hypertrophy, squamous epithelial hyperplasia, and submucosal granulomatous inflammation of the forestomach were caused by irritation of this substance, the digestive tract was not taken as a target. From the above, the substance was classified in Category 3 (respiratory tract irritation, narcotic effects). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. In a 14-day gavage administration toxicity test using rats, mucosal hypertrophy of the forestomach was observed at 300 mg/kg/day (converted to a 90-day equivalent: 46.7 mg/kg/day) corresponding to Category 2 (Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2002); Result of the initial environmental risk assessment of chemicals, Vol. 4, Ministry of the Environment in Japan, Tentative hazard assessment sheet (2005)). Besides, in a combined repeated dose toxicity/reproductive developmental toxicity test using rats in an oral route (by gavage), squamous epithelial metaplasia of the forestomach was found at 100 mg/kg/day (converted to a 90-day equivalent: 54.4 mg/kg/day) corresponding to Category 2 (Rationale for setting the Recommendation of Acceptable Concentration of the Japan Society for Occupational Health (2002); Result of the initial environmental risk assessment of chemicals, Vol. 4, Ministry of the Environment in Japan, Tentative hazard assessment sheet (2005); SIDS (2005); Initial Risk Assessment, NITE (2008)). Because these lesions in the forestomach are considered to be caused by irritation, they were not used for the classification. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 3 |
- |
H402 | P273 P501 |
From 72-hour ErC50 = 81 mg/L for algae (Pseudokirchneriella subcapitata) (Ecotoxicity tests by Environment Agency, 1996), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 2 |
 - |
H411 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 2 due to lack of rapid degradability (BioWin), and 21-day NOEC (reproduction) = 0.94 mg/L for crustacea (Daphnia magna) (Ecotoxicity tests by Environment Agency, 1996; SIDS, 2007; Initial Risk Assessment, NITE, 2008). 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 96-hour LC50 >100 mg/L for fish (Oryzias latipes) (Ecotoxicity tests by Environment Agency, 1996; SIDS, 2007; Initial Risk Assessment, NITE, 2008) and water solubility of 176.4 g/L (NITE Chemical Risk Information Platform, 2015) although it is not rapidly degradable (BioWin). It was classified in Category 2 by drawing a comparison between the above results. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
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. |