GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 941-69-5 |
| Chemical Name | N-Phenylmaleimide |
| Substance ID | H29-B-061 |
| Classification year (FY) | FY2017 |
| 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 | FY2008 |
| 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 |
- |
- | - | There is the information that it is poorly flammable (GESTIS (Access on June 2017)), 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 | Classification not possible |
- |
- | - | No data available. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) 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 |
- |
- | - | 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) | Category 3 |
 Danger |
H301 |
P301+P310
P264 P270 P321 P330 P405 P501 |
Based on reports of LD50 values of 153 mg/kg (males) and 188 mg/kg (females) for rats (JECDB (Access on June 2017)), this substance was classified in Category 3. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. There were no in vivo data. As for in vitro, this substance was positive in a bacterial reverse mutation test and a chromosomal aberration test with mammalian cultured cells (JECDB (Access on June 2017)). |
| 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 the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422), adverse effects were not observed on fertility and on the development of the next generation even at the high dose (20 mg/kg/day), at which deaths were observed in maternal animals (3/12 cases) (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). However, as this test was a screening test, this substance could not be classified as "Not classified" based on the result alone. Therefore, this substance was classified as "Classification not possible" due to a lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | There is no information on single exposures to this substance in humans. As for experimental animals, it was reported that, in a single oral dose test with rats, suppression of body-weight gains were observed at and above 62.5 mg/kg; a decrease in locomotor activity, adoption of the prone position, and paleness of the auricles and limbs were observed at or above 125 mg/kg; and the LD50 value was 153 mg/kg for males and 188 mg/kg for females (JECDB (Access on June 2017)). It was reported that in this test, mucosal thickening in the forestomach was observed on autopsy of survivors at or above 62.5 mg/kg; on histopathological examination, hyperkeratosis, acanthosis, inflammation of the subepithelial tissue, and fibrosis of the subepithelial tissue in the forestomach were observed at or above 62.5 mg/kg, and also infiltration of lymphatic-system cells in the subepithelial tissue was observed at or above 125 mg/kg (JECDB (Access on June 2017)). The effects on the forestomach were not adopted as evidence of the classification as there is no forestomach in humans. Since the target organs could not be identified from the other symptoms, this substance was classified as "Classification not possible." The classification result was changed from the previous classification. |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
No information on humans is available. As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422), hyperkeratosis, epithelial hyperplasia, and inflammatory cellular infiltration in the mucosa, etc. were observed in the forestomach at or above 2.5 mg/kg/day (converted guidance value: 1.1 mg/kg/day); soiled fur, a tendency toward suppression of body-weight gains, decreases in prothrombin time and activated partial thromboplastin time, decreased total protein and albumin concentrations, and increased spleen weights were observed at 20 mg/kg/day (converted guidance value: 10.9 mg/kg/day) (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). From the above, effects were observed in the stomach, but these were not adopted as evidence of the classification because these effects were considered to be due to irritation. Since no other clear toxic effects were observed, 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) | Classification not possible |
- |
- | - | No data available. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data available. |
| 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. |