GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 569-64-2 |
| Chemical Name | N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium, chloride [Malachite green] |
| Substance ID | H29-B-111 |
| 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 |
- |
- | - | No data available. |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group associated with self-reactive properties (ethylene group) in the molecule, but the classification is not possible due to no data. |
| 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 |
- |
- | - | 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 |
- |
- | - | It is an organic compound which does not contain fluorine or oxygen but contains chlorine, and the chlorine is ionically bonded to the element other than carbon or hydrogen (N) and does not contribute to oxidation. |
| 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 a report of an LD50 value of 80 mg/kg (HSDB (Access on August 2017)) for mice, it 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 | Category 1 |
 Danger |
H318 |
P305+P351+P338
P280 P310 |
There is a report that it is injurious to human eyes (NTP TOX71 (2004)). Based on the description that in an eye irritation test with rabbits (OECD TG 405 compliant), eye damage occurred and this did not resolve until after 8 days (ECHA registration dossier (Access on November 2017)), and the description of severe injury ranging from conjunctival edema, hyperemia, and purulence to total opacification and even necrosis of the cornea, and sloughing of the corneal stroma in another test with rabbits (HSDB (Access on August 2017)), it was classified in Category 1. Besides, this substance was classified as "Eye Dam. 1, H318" in EU CLP classification (ECHA CL Inventory (Access on August 2017)). |
| 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 | Category 1B |
 Danger |
H340 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, this substance was negative in a micronucleus test with rat bone marrow cells, positive and negative in micronucleus tests with mouse bone marrow cells, negative in a micronucleus test with mouse peripheral blood, positive in chromosomal aberration tests with bone marrow cells and spermatocytes of mice, negative in gene mutation tests (hprt locus) with spleen lymphocytes and peripheral blood of mice and a gene mutation test (hepatic cII gene) with transgenic mice, and positive in DNA adduct formation tests with the liver of rats and mice (NICNAS (Access on September 2017), Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005), EFSA (2016), NTP TR527 (2005), NTP DB (Access on September 2017)). As for in vitro, there were mostly negative results in bacterial reverse mutation tests, and it was negative in a gene mutation test and a chromosomal aberration test with mammalian cultured cells (NICNAS (Access on September 2017), Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005), EFSA (2016), NTP TR527 (2005), NTP DB (Access on September 2017)). From the above, based on the positive results in the in-vivo germ cell mutagenicity test, the in-vivo somatic cell mutagenicity tests, and the in vivo somatic cell genotoxicity test, it was classified in Category 1B according to the GHS classification guidance for the Japanese government. |
| 6 | Carcinogenicity | Category 2 |
Warning |
H351 |
P308+P313
P201 P202 P280 P405 P501 |
In 2-year carcinogenicity studies with female rats and female mice dosed by feeding, it was concluded that there was equivocal evidence of carcinogenicity based on increased thyroid gland follicular cell adenoma and slight increases in hepatocellular adenoma and mammary gland carcinoma in female rats, but it was concluded that since there was no tumor development associated with the administration in the administration test with female mice, there was no evidence of carcinogenicity (NTP TR527 (2005)). Regarding these NTP test results, the Food Safety Commission concluded that carcinogenicity in the liver and mammary glands of female rats was suggested for this substance though it was weak (Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005)). On the other hand, CONTAM Panel of EFSA concluded that this substance did not show carcinogenicity in mice, but this substance had a carcinogenic potential in rats because slight increases in thyroid follicular tumors and mammary gland carcinoma were observed (EFSA (2016)). From the above, following the assessment results of Food Safety Commission and EFSA based on the NTP test results, it was judged as appropriate to classify this substance in Category 2 for carcinogenicity. Besides, the classification result was changed due to the use of new information sources. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there is a report when pregnant rats were dosed orally at up to 500 mg/kg/day during the critical period, no effect on the incidence of skeletal malformations was observed (HSDB (Access on August 2017)). |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. There is no single exposure information on this substance in humans and experimental animals. Besides, there is a report that in a single oral dose test in which malachite green oxalate (CAS RN 2437-29-8) was administered to rats at 300, 450, 600, 750 mg/kg, an LD50 value was 520 mg/kg, and sedation, weakness, and coma were observed as symptoms (NTP TOX71 (2004), NICNAS IMAP (Access on March 2017)) (this was described in NICNAS IMAP as the data of this substance, but this was found to be the result from tests on the oxalate after the confirmation of the original source). Since, as also for oxalic acid (CAS RN 144-62-7), weakness and coma, etc. are reported as acute toxicity symptoms by oral ingestion (GHS Classification in FY2016), symptoms due to the ingestion of malachite green oxalate were not used as a reference for classification because the symptoms were possibly effects of oxalic acid. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (thyroid), Category 2 (haemal system, liver) |
Danger Warning |
H372
H373 |
P260
P264 P270 P314 P501 |
No information on humans is available. In 28-day tests with rats and mice dosed by feeding, in rats, within the guidance value range for Category 2, increased liver weight and decreased mean corpuscular hemoglobin content at or above 300 ppm (converted guidance value: 12.4 mg/kg/day), decreased mean corpuscular volume and increased gamma-GT activities at or above 600 ppm (converted guidance value: 21.8 mg/kg/day (male), 23.3 mg/kg/day (female)), and decreases in the erythrocyte count, hemoglobin concentration, hematocrit value and mean corpuscular hemoglobin concentration, and hepatocellular vacuolation at 1,200 ppm (converted guidance value: 54.4 mg/kg/day (male), 59.1 mg/kg/day (female)) were observed. In mice, decreased erythrocyte count at or above 100 ppm (converted guidance value: 6.2 mg/kg/day) within the guidance value range for Category 1, and decreases in hemoglobin concentration and hematocrit value, and increased reticulocyte count at or above 300 ppm (converted guidance value: 15.6 mg/kg/day (male), 20.2 mg/kg/day (female)) within the guidance value range for Category 2 were observed (NTP TOX71 (2004)). Other than these, in a 2-year test with rats dosed by feeding, cyst formation from the thyroid follicular epithelium at or above 100 ppm (converted guidance value: 7 mg/kg/day) within the guidance value range for Category 1, hyperplasia of the thyroid follicular epithelium at or above 300 ppm (converted guidance value: 21 mg/kg/day) within the guidance value range for Category 2 were observed, and increased liver weight and increased eosinophilic foci in the liver at or above 600 ppm (converted guidance value: 43 mg/kg/day) within the guidance value range for Category 2 were observed (NTP TR527 (2005), Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005)). Therefore, it was classified in Category 1 (thyroid), and Category 2 (haemal system, liver). Besides, the classification result was different from the previous classification due to the use of new information. |
| 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 1 |
 Warning |
H400 |
P273
P391 P501 |
From 48-hour EC50 = 0.13 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (BioWin), and 72-hour NOEC (rate method) = 0.049 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (BioWin), and 48-hour EC50 = 0.13 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)). From the above results, it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
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* 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. |