GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTES:
Updated date:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS number | 61-73-4 |
| Chemical name | Methylene blue |
| Substance ID | 23A5151 |
| Fiscal year of classification conducted | FY2011 |
| Classifier(s) (Ministries) | Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE） |
| New/Revised | New |
| Download in Excel format | Excel file |
| Item | Information |
|---|---|
| Guidance used for classification (External link) |
Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government （July, 2010）
Environmental Hazards: UN GHS Document （4th revised edition） |
| 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 (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
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 | - | - | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable | - | - | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Classification not possible | - | - | - | 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 | - | - | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Classification not possible | - | - | - | No data. |
| 11 | Self-heating substances and mixtures | Classification not possible | - | - | - | No established test method suitable for solid substances with a melting point of 140 degrees C or lower. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable | - | - | - | Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Not applicable | - | - | - | It is conceivable that an organic compound containing chlorine which is ionically bonded does not contribute to oxidizing. |
| 15 | Organic peroxides | Not applicable | - | - | - | An organic compound that does not contain -O-O- structure. |
| 16 | Corrosive to metals | Classification not possible | - | - | - | No established test method suitable for solid substances. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity （Oral） | Category 4 |  |
H302 |
P301+P312 P264 P270 P330 P501 |
On the basis of an LD50 value of 1180 mg/kg for rats (NTP TR 540 (2008)), it was classified in Category 4. |
| 1 | Acute toxicity （Dermal） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Gases） | Not applicable | - | - | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity （Inhalation: Vapours） | Classification not possible | - | - | - | No data. |
| 1 | Acute toxicity （Inhalation: Dusts and mists） | Classification not possible | - | - | - | No data. |
| 2 | Skin corrosion/irritation | Classification not possible | - | - | - | No data. |
| 3 | Serious eye damage/eye irritation | Classification not possible | - | - | - | No data. |
| 4 | Respiratory sensitization | Classification not possible | - | - | - | No data. |
| 4 | Skin sensitization | Classification not possible | - | - | - | No data. |
| 5 | Germ cell mutagenicity | Not classified | - | - | - |
On the basis of a negative result in a micronucleus test using bone marrow or peripheral blood after intraperitoneal administration of a trihydrate of this substance to mice (in vivo somatic cell mutagenicity test) (NTP DB (1992)), it was classified as "Not classified." Besides, a micronucleus test by intravenous administration to mice also reported a negative (EMEA (2011)), while all in vitro tests, an Ames test, a chromosomal aberration test using CHO cells, and a gene mutation test using mouse lymphoma, reported positives (NTP DB (1992), EMEA (2011)). |
| 6 | Carcinogenicity | Classification not possible | - | - | - |
Lack of data. Besides, a 2-year oral administration test of a trihydrate of this substance using rats and mice reported an increased incidence of islet cell adenoma, adenoma, and carcinoma as limited evidence of carcinogenicity in male rats, but no evidence of carcinogenicity in female rats. And an increased incidence of malignant lymphoma as limited evidence of carcinogenicity in male mice, and a marginally increased incidence of malignant lymphoma as equivocal evidence of carcinogenicity in female mice were reported. (NTP TR 540 (2008)) |
| 7 | Reproductive toxicity | Category 2 |  |
H361 |
P308+P313 P201 P202 P281 P405 P501 |
A developmental toxicity test by oral administration of a trihydrate of this substance to pregnant rats during an organogenesis period reported an increase in resorptions by 25% in the highest dose group (200 mg/kg), which had general toxicity such as decreased weight gain and increased weights of spleen and liver in maternal animals, compared to 4% in a control group. (NTP TER 92124 (1994)) And subcutaneous administration of this substance to pregnant mice reported no general toxicity in maternal animals but preterm delivery, axial skeleton and neural tube defects, and fetal developmental disorders. (HSDB (2009)) On the basis of the reports, it was classified in Category 2. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (blood system) | |
H370 |
P307+P311 P260 P264 P270 P321 P405 P501 |
There is the information that intravenous administration of a large dose (about 500 mg) caused methemoglobinemia in humans (NTP TR 540 (2008)). There is the information that this substance is especially toxic to newborns and a case of a preterm infant who had methemoglobinemia and hemolytic anemia after enteral administration (HSDB (2009)). And there is the information that three premature neonates exposed to this substance had severe hemolytic anemia requiring exchange transfusions (HSDB (2009)). Therefore, it was classified in Category 1 (blood system). Besides, an animal test reported hemoconcentration, hypothermia, increases in blood pressure, hypercapnia, and so on without details (NTP TR 540 (2008)). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (blood system) | |
H372 |
P260 P264 P270 P314 P501 |
In a 3-month repeated oral administration test on a trihydrate of this substance using rats and mice (doses: 0, 25, 50, 100, 200 mg/kg), increased spleen weights and hematopoietic cell proliferation, in addition to methemoglobinemia and a regenerative Heinz body anemia in all doses were observed in both animal species. Furthermore, congestion in a spleen, lymphoid depletion of the lymphoid follicles, capsular fibrosis, hyperplasia or pigmentation of bone marrow were observed. And incidence of hematopoietic cell proliferation and Kupffer cell pigmentation in the liver significantly increased at doses of 50 or 100 mg/kg/day or higher in mice. (NTP TR 540 (2008)). Similar findings were observed in a 1-month or 2-year repeated oral administration test on a trihydrate in rats and mice. And effects reported in the 2-year test was 2.5 to 5 mg/kg/day (equivalent to 2.14 to 4.28 mg/kg/day of an anhydrate by a molecular weight conversion) or higher which corresponds to Category 1 in a range of guidance values. Therefore, it was classified in Category 1 (blood system). |
| 10 | Aspiration hazard | Classification not possible | - | - | - | No data. |
| Hazard class | Classification |
Pictogram (Code: symbol) Signal word |
Code (Hazard statement) |
Code (Precautionary statement) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment （Acute） | Category 3 | - |
H402 |
P273 P501 |
From 96-hour LC50 = 12 mg/L for fish (Morone saxatilis) (AQUIRE, 2012), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment （Long-term） | Category 3 | - |
H412 |
P273 P501 |
Reliable chronic toxicity data were not obtained. Due to lack of rapid degradability (BIOWIN), and acute toxicity Category 3, it was classified in Category 3. |
| 12 | Hazardous to the ozone layer | Classification not possible | - | - | - | This substance is not listed in Annexes to the Montreal Protocol. |
NOTES:
|
* 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. |
Updated date:
|
2016/10/13 Addition of Rationale for the classification |