GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
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

REFERENCE INFORMATION
Item Information
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

PHYSICAL HAZARDS
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."

HEALTH HAZARDS
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.

ENVIRONMENTAL HAZARDS
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.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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