Item | Information |
---|---|
CAS RN | 119313-12-1 |
Chemical Name | 2-Benzyl-2-(N,N-dimethylamino)-1-(4-morpholinophenyl)butan-1-one |
Substance ID | R02-A-002-MHLW, MOE |
Classification year (FY) | FY2020 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
New/Revised | New |
Classification result in other fiscal year | |
Download of Excel format | Excel file |
Item | Information |
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Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
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 classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. Therefore, it was classified as "Not classified." |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified." |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified." |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. |
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. |
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." |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified." |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified." |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. |
17 | Desensitized explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (REACH registration dossier (Access on June 2020)) |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (REACH registration dossier (Access on June 2020)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified." |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) No skin reactions were observed in a skin irritation test with rabbits according to OECD TG 404 (REACH registration dossier (Access on June 2020)). (2) No skin reactions were seen in a skin irritation test with rabbits according to EU Method B.4 (Acute Toxicity: Dermal Irritation/Corrosion) (REACH registration dossier (Access on June 2020)). |
3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) In an eye irritation test with rabbits according to OECD TG 405, slight irritation reactions were observed from 1 to 24 hours after application but disappeared after 72 hours (REACH registration dossier (Access on June 2020)). (2) In an eye irritation test with rabbits according to EU Method B.5, slight conjunctival redness was seen but disappeared by 72 hours (REACH registration dossier (Access on June 2020)). |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
4 | Skin sensitization | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) It is reported that it was negative in a skin sensitization test (Buehler test) with guinea pigs according to OECD TG 406 (REACH registration dossier (Access on June 2020)). (2) It is reported that it was negative in a skin sensitization test (maximization test) with guinea pigs according to EU Method B.6 (REACH registration dossier (Access on June 2020)). |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] Based on (1) and (2), was classified as "Not classified." [Evidence Data] (1) As for in vivo, in a micronucleus test with the bone marrow of orally dosed Chinese hamsters, negative results were reported (REACH registration dossier (Access on July 2020)). (2) As for in vitro, in a bacterial reverse mutation test, a mammalian cell chromosome aberration test, and a mammalian cell gene mutation test, negative results were reported (REACH registration dossier (Access on July 2020)). |
6 | Carcinogenicity | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification was not possible due to lack of data. |
7 | Reproductive toxicity | Category 2 |
Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1), since adverse effects on the development of offspring were observed at a maternal toxicity dose, it was classified in Category 2. [Evidence Data] (1) In a one-generation reproduction toxicity study with rats (OECD TG 415), at a dose for maternal toxicity (reduced body weight gain, an increase in liver weight with centrilobular to midzonal hepatocellular hypertrophy of the liver), offspring toxicity (a reduction in live birth index, an increased number of stillborn pups, a reduction in survival rate) was observed. At less than the maternal toxicity dose, a significant increase in the number of stillborn pups was observed within the range of the background data (EU CLP CLH (2015)). [Reference Data, etc.] (2) The RAC opinion (2016) indicated that the maternal effects at high doses in the above study were not likely to be the direct cause of the developmental effects observed given their magnitude and nature, and that the developmental effects were observed at medium doses at which stress in the dams and severe maternal toxicity were not observed. Therefore, based on the fact that the observed developmental effects were not considered to be a secondary non-specific consequence of the maternal toxicity, that the quality of the study was good, and that stillbirth and postnatal mortality were considered to be severe effects relevant to humans, it was determined that the reproduction category 1B was more appropriate than Category 2. (3) In the EU CLP classification, it was classified as Repr.1B (Classification in EU CLP (Access on April 2020)) |
8 | Specific target organ toxicity - Single exposure | Category 2 (systemic) |
Warning |
H371 | P308+P311 P260 P264 P270 P405 P501 |
[Rationale for the Classification] There was no report on single exposure to this substance in humans. In test animals, toxic symptoms in (1) and (2) were observed, but affected organs could not be identified from the described symptoms. Therefore, it was classified in Category 2 (systemic toxicity). [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats, at 2,000 mg/kg (within the range for Category 2) or 5,000 mg/kg (within the range exceeding Category 2), dyspnea, exophthalmos, ruffled fur, and curved body position were observed (REACH registration dossier (Access on June 2020)). (2) It was reported that in an acute dermal toxicity test with rats, at 2,000 mg/kg (within the range for Category 2), piloerection, abnormal body positions, and dyspnea were observed (REACH registration dossier (Access on June 2020)). |
9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | [Rationale for the Classification] There was no report on repeated exposure to this substance in humans. It was reported that in test animals, effects on the blood system were observed based on (1), and effects on the liver were observed based on (1) and (2), but those effects were not adopted as evidence because there were no sufficient data for effects on the blood system, and for effects on the liver, the effects of the initial high-dose administration could not be eliminated in (1), and effects were observed only at a dose exceeding Category 2 in (2). Therefore, it was determined that classification was not possible. [Reference Data, etc.] (1) In an oral toxicity test with rats, in which 500 mg/kg of this substance was administered for 9 days, and after a 5-day recovery period, 250 mg/kg (converted guidance value: 77.8 mg/kg, within the range for Category 2) was administered for 28 days, an increase in prothrombin time, reductions in reticulocyte count and platelet count, hepatocyte hypertrophy, and an increase in absolute liver weight were observed, in addition, red-brown discoloration of the liver was observed in females (CLH Report (2015)). (2) In an oral toxicity test with rats (one-generation reproduction toxicity study, administration period: 110 days for males and 126 days for females), at or above 100 mg/kg (within the range for Category 2), an increase in liver weight, and mucosal hyperemia of the glandular stomach were observed; and at 300 mg/kg (within the range exceeding Category 2), central and midzonal hepatocellular hypertrophy of the liver was observed. In hepatocytes, granular pigment deposits increased as the dose increased. However, adverse effects on the liver were observed only at 300 mg/kg, and it was considered that the findings of the stomach were caused by irritation (CLH Report (2015)). |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] 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 Short term (Acute) | Category 1 |
Warning |
H400 | P273 P391 P501 |
It was classified in Category 1 from 96-hour LC50 = 0.46 mg/L for fish (Danio rerio) (EU CLP CLH, 2017). |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 1 |
Warning |
H410 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 because it was not rapidly degradable (a 28-day degradation rate by BOD in a test according to OECD TG301B: 0% (EU CLP CLH, 2017)) and due to 72-hour NOErC = 0.1 mg/L for algae (Desmodesmus subspicatus) (EU CLP CLH, 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 because it was not rapidly degradable (a 28-day degradation rate by BOD in a test according to OECD TG301B: 0% (EU CLP CLH, 2017)) and due to 96-hour LC50 = 0.46 mg/L for fish (Danio rerio) (EU CLP CLH, 2017). From the above results, it was classified in Category 1. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
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