Item | Information |
---|---|
CAS RN | 129-73-7 |
Chemical Name | N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline; Leucomalachite green |
Substance ID | m-nite-129-73-7_v1 |
Download of Excel format | Excel file |
Item | Information |
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Guidance used for the classification (External link) | To Guidance List |
UN GHS document (External link) | To UN GHS document |
FAQ(GHS classification results by the Japanese Government) | To FAQ |
List of Information Sources (Excel file) | List of Information Sources |
List of Definitions/Abbreviations | Definitions/Abbreviations |
Sample Label by MHLW (External link) | To Workplace Safety Site (MHLW) |
Sample SDS by MHLW (External link) | To Workplace Safety Site (MHLW) |
OECD/eChemPortal (External link) | To OECD/eChemPortal (External link) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified (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). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
17 | Desensitized explosives | Not classified |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)." |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
4 | Skin sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
5 | Germ cell mutagenicity | Category 2 |
Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Because there were positive results in some in vivo tests in (1), this substance was recognized as mutagenic in (3) and (4), and this substance is a metabolite of malachite green which was classified in Category 1B as in (5), it was classified in Category 2. [Evidence Data] (1) As for in vivo, it was almost negative in rodent micronucleus tests. It was, however, weakly positive in a micronucleus test with peripheral blood of mice exposed to the highest dosage. Also, in a cII gene mutation test on transgenic animals, it was negative in rats and positive in mice. Additionally, in a liver DNA adduct formation test, it was negative in mice and positive in rats. On the other hand, it was negative in spleen lymphocyte HPRT tests in transgenic animals (rats and mice) (NTP TR527 (2005), JECFA FAS61 (2009), JECFA TRS 954 (2009), EFSA (2016), NTP DB (Access on May 2019), Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005)). (2) As for in vitro, it was negative in a mammalian cell HPRT test and a bacterial reverse mutation test (NTP TR527 (2005), JECFA FAS61 (2009), JECFA TRS 954 (2009), Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005)). (3) It is concluded in the joint statement of UK COM (The Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment) and UK COC (Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment) that this substance should be considered as an in vivo mutagenic substance (Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005)). (4) It was classified in Carc. 2 in EU harmonized CLP classification. (5) This substance is a metabolite of malachite green (CAS RN 569-64-2) (Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005)) which was positive in an in vivo chromosomal aberration test with mouse spermatocytes (EFSA (2016)). Therefore, it was classified in Category 1B in Japan (GHS classification in FY2017). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
6 | Carcinogenicity | Category 2 |
Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on EU CLP classification (1) corresponding to Category 2, and the fact that carcinogenicity was confirmed in (2) to (4), it was classified in Category 2. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Carc.2 in EU CLP (EU CLP classification (Access on May 2019)). (2) In a carcinogenicity test with male and female rats dosed with this substance by feeding for 2 years, slight increases in the incidence of thyroid gland follicular cell adenomas or carcinomas (combined) in both sexes, increases in bilateral testicular interstitial cell adenoma in males, and slight increases in hepatocellular adenoma in females were observed (equivocal evidence) (NTP TR527 (2005), Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005), EFSA (2016), JECFA FAS61 (2009)). (3) In a carcinogenicity test with female mice dosed with this substance by feeding for 2 years, an increased incidence of hepatocellular adenoma or carcinoma (combined) was observed (some evidence) (NTP TR527 (2005), Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005), EFSA (2016), JECFA FAS61 (2009)). (4) Food Safety Commission of Japan expressed its opinions that the carcinogenic risk of this substance for humans was unclear, however, animal test results suggested its carcinogenicity, and genetic toxicity was undeniable (Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005)). On the other hand, the EFSA Panel concluded that this substance may be considered as carcinogenic (EFSA (2016)) based on the observations that an increase in hepatocellular adenomas and a small increase in hepatocellular carcinomas in mice and increases in the incidence of mammary gland carcinomas and of thyroid gland follicular cell adenomas or carcinomas (combined) in rats were observed. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
7 | Reproductive toxicity | Category 2 |
Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1), since an increase in post-implantation losses was observed at a dosage of maternal toxicity, it was classified in Category 2. [Evidence Data] (1) In a developmental toxicity test with female rats orally administered (by gavage) on gestational Days 6-15, an increased incidence of fetuses with skeletal abnormalities (predominant abnormalities were bipartite ossification of the thoracic centrum), increases in post-implantation losses, decreases in fetal body weight and placental weight, and an increased incidence of fetuses with visceral abnormalities (hydronephrosis) were observed at a dosage of maternal toxicity (a severe reduction in maternal weight and feed consumption) (EFSA (2016), HSDB (Access on May 2019)). |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (thyroid, liver), Category 2 (urinary bladder, blood system) |
Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1) to (4), in oral dose toxicity tests with rats and mice, effects on the thyroid and liver at doses within the range for Category 1, and effects on the urinary bladder and blood system at doses within the range for Category 2 were observed. Therefore, it was classified in Category 1 (thyroid, liver) and Category 2 (urinary bladder, blood system). [Evidence Data] (1) In a 28-day feeding toxicity test with male rats, increases in liver weight at or above 290 ppm (converted guidance value: 9 mg/kg/day, within the range for Category 1), decreased body weight gain and hepatocellular vacuolization at or above 580 ppm (converted guidance value: 19 mg/kg/day, within the range for Category 2), and less body weight, anemic tendency (decreased hemoglobin, hematocrit value, and erythrocyte counts, etc.) and an increase in gamma-GT activity at 1,160 ppm (converted guidance value: 36 mg/kg/day, within the range for Category 2) were observed (NTP TR527 (2005), Risk Assessment Report (Veterinary Medicinal Products) (Food Safety Commission of Japan, 2005), EFSA (2016)). (2) In a 28-day feeding toxicity test with female mice, increases in liver weight at or above 290 ppm (converted guidance value: 19 mg/kg/day, within the range for Category 2), decreased body weight gain at or above 580 ppm (converted guidance value: 34 mg/kg/day, within the range for Category 2), and less body weight and apoptosis in the transitional epithelium cells of the urinary bladder at 1,160 ppm (converted guidance value: 68 mg/kg/day, within the range for Category 2) were observed (the same as in the above data). (3) In a 2-year feeding toxicity test with rats, acidophilic foci and cystic degeneration in the liver and follicular cysts in the thyroid at 91 ppm (male: 5 mg/kg/day, female: 6 mg/kg/day, within the range for Category 1), and hepatocellular vacuolization at or above 272 ppm (17 mg/kg/day, within the range of Category 2) were observed as non-neoplastic lesions (the same as in the above data). (4) In a 2-year feeding toxicity test with female mice, an increased incidence of intracytoplasmic inclusions in the transitional epithelium of the urinary bladder was observed at 91 ppm (13 mg/kg/day, within the range for Category 2) as non-neoplastic lesions (the same as in the above data). [Reference Data, etc.] (5) Malachite green (CAS RN 569-64-2) which is a precursor of this substance was classified in Category 1 (thyroid) and Category 2 (blood system, liver) in GHS classifications in FY2017. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | Classification year (FY) | GHS Classification Guidance for the Japanese Government | |
---|---|---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
11 | Hazardous to the aquatic environment Long term (Chronic) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | Classification not possible due to lack of data. | FY2019 | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
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