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 |
| Substance ID | H28-B-018, C-026B |
| Classification year (FY) | FY2016 |
| 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 | FY2015 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 |
- |
- | - | A flash point is 164 deg C (closed cup) (GESTIS (Access on May 2016)). |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group associated with self-reactive properties (unsaturated bond) present in the molecule, but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 415 deg C (GESTIS (Access on May 2016)). |
| 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 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 |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
| 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 |
- |
- | - |
It is reported that the LD50 values for rats were 1,900 mg/kg (SIDS (2005)), > 2,000 mg/kg (SIDS (2005), JECDB (Access on May 2016)) and 2,590 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2002)). Since there is one report corresponding to Category 4 and two reports corresponding to "Not classified," it was classified as "Not classified" (Category 5 in UN GHS classification) which has the largest number of reports. The classification was changed by the revision of the GHS classification guidance for the Japanese Government. |
| 1 | Acute toxicity (Dermal) | Category 4 |
 Warning |
H312 |
P302+P352
P362+P364 P280 P312 P321 P501 |
It is reported that the LD50 values for rabbits were 1,710 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) and 2,589 mg/kg (OEL Documentations (Japan Society For Occupational Health (JSOH), 2002)). Since there is one report corresponding to Category 4 and one report corresponding to "Not classified," it was classified in Category 4 to which the lowest LD 50 value corresponds. The classification was changed by addition of new information. |
| 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. |
| 2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
Although it was not a 4-hour application study, it is reported that in a skin irritation study using rabbits, a moderate irritation was observed (SIDS (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Therefore, this substance was classified in Category 2. |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
It is reported that in an eye irritation study using rabbits, irritation to the eyes was observed, and that it was not completely reversible on the 10th day after application (SIDS (2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), therefore, the substance was classified in Category 2A. Besides, this substance was classified as "Eye Dam. 1 H318" in EU CLP classification (ECHA C&L Inventory (Access on May 2016)). |
| 4 | Respiratory sensitization | Category 1 |
 Danger |
H334 |
P304+P340
P342+P311 P261 P284 P501 |
There are several epidemiological case reports that suggest respiratory sensitization in humans (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), The Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). This substance was also classified as "Airway Sensitizers (Group 1)" (Recommendation of Occupational Exposure Limits vol. 44 (Japan Society For Occupational Health, 2002)). Therefore, this substance was classified in Category 1. Besides, this substance was classified as "Resp. Sens. 1 H334" in EU CLP classification (ECHA C&L Inventory (Access on May 2016)). |
| 4 | Skin sensitization | Category 1 |
Warning |
H317 |
P302+P352
P333+P313 P362+P364 P261 P272 P280 P321 P501 |
Based on several epidemiological case reports that suggest skin sensitization in humans (Initial Risk Assessment Reports (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)), this substance was classified in Category 1. Besides, this substance was classified as "Skin. Sens. 1 H317" in the EU CLP classification (ECHA C&L Inventory (Access on May 2016)). |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. There were no available data in vivo. As for in vitro, bacterial reverse mutation tests and mammalian cell chromosomal aberration tests were negative (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2005), JECDB (Access on May 2016), OEL Documentations (Japan Society For Occupational Health (JSOH), 2002)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
In a combined repeated dose toxicity study with reproduction/developmental toxicity screening test (OECD TG 422) using rats administered by gavage, no reproductive or developmental effects were observed at up to 300 mg/kg/day in both parent animals and offspring (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), The Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), SIDS (2005)). However, it is difficult to classify as "Not classified" because it was a screening test, so it was classified as "Classification not possible." |
| 8 | Specific target organ toxicity - Single exposure | Category 3 (Respiratory tract irritation) |
Warning |
H335 |
P304+P340
P403+P233 P261 P271 P312 P405 P501 |
It is described that in humans this substance causes pain of the pharynx, sneezing, nose secretion, nose blockage, cough and asthma (SIDS (2002)). Therefore, this substance was classified in Category 3 (respiratory tract irritation). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. In combined repeated dose toxicity studies with reproduction/developmental toxicity screening tests (OECD TG 422) using rats administered by gavage, lesions of the forestomach attributed to irritation were observed. However, there was no effect to be the basis of classification (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), SIDS (2005)). |
| 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 3 |
- |
H402 |
P273
P501 |
From 72-hour ErC50 = 81 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996)), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 2 |
 - |
H411 |
P273
P391 P501 |
Because it is not rapidly degradable (BIOWIN), and its 21-day NOEC (reproduction) = 0.94 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Initial Risk Assessment (NITE, CERI, NEDO, 2008)), it was classified in Category 2. |
| 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. |