NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	15875-13-5
Chemical Name	1,3,5-Tris[3-(dimethylamino)propyl]hexahydro-1,3,5-triazine
Substance ID	R03-A-021-METI, MOE
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/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)
Model SDS by MHLW (External link)
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.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point is 100.5 deg C (closed cup) (REACH (Accessed May 2021)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
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.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 215 deg C (744 mmHg) (REACH (Accessed May 2021)).
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid 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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

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] Based on (1) and (2), it was classified as "Not classified" (Category 5 in UN GHS classification). [Evidence Data] (1) LD50 for rats (males): 2,519 mg/kg (REACH registration dossier (Accessed May 2021)) (2) LD50 for rats (males): 4,650 mg/kg (REACH registration dossier (Accessed May 2021))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rabbits: 1,566 mg/kg (REACH registration dossier (Accessed May 2021))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), no category could be identified and classification was not possible. Besides, the exposure concentration was lower than the saturated vapor pressure concentration (5,262 ppm: 73.6 mg/L) and the substance was judged as being in the vapor state. In addition, the exposure concentration was lower than 90% (66.3 mg/L) of the saturated vapor pressure concentration, and the judgment for this substance was made based on the reference value for gas (reference value in units of ppm). [Reference Data, etc.] (1) LC50 (8 hours) for rats: > 0.51 mg/L (converted 4-hour equivalent value: 0.72 mg/L: 51.4 ppm) (OECD TG 403) (REACH registration dossier (Accessed June 2021))
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] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in a skin irritation test with rabbits (n=6) (occlusive, 4-hour application, 21-day observation), mild erythema and edema were observed on the abraded skin but no skin irritation reaction was observed on the intact skin (REACH registration dossier (Accessed May 2021)). [Reference Data, etc.] (2) It was reported that, in a skin irritation test with rabbits (n=5) (open, 24-hour application, 24-hour observation), skin irritation whose score was 5 (full scale: 10) was observed at 24 hours after application but it was not a corrosive effect (REACH registration dossier (Accessed May 2021)). ⇒最高濃度（50％）で閾値（SI値：3）に等しい値が得られ、50％濃度群では皮膚の紅斑とともに、耳介重量の増加がみられたが、感作性影響かどうかは不明瞭であった (3) In a skin irritation test with rabbits (n=2) (occlusive, 8-day observation), this substance was applied for 1 minute, 5 minutes, and 15 minutes and no skin irritation reactions were observed at 24 to 72 hours after application. It was reported that, when it was applied for 20 hours, scaling was observed at 24 hours after application in one case and induration was observed at 72 hours after application in another case (REACH registration dossier (Accessed May 2021)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) It was reported that, in an acute eye irritation/corrosion test with rabbits (n=2) (equivalent to OECD TG 405, 8-day observation), the eyes clotted at 72 hours after application in all cases and the effects were irreversible (REACH registration dossier (Accessed May 2021)). (2) It was reported that, in an eye irritation test with rabbits (n=8), irritation effects were reversible within 22 days in 5 cases in the washed eyes group, while irritation effects persisted until 30 days after application in 3 cases in the unwashed eyes group (REACH registration dossier (Accessed May 2021)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] In the findings of (1), negative results were obtained, and in the findings of (2), values equivalent to the threshold (SI value: 3) were obtained. Therefore, it was ambiguous whether this substance elicited a sensitizing response, and classification was not possible. [Reference Data, etc.] (1) It was reported that, in a local lymph node assay (LLNA) with mice (n=5/group) (OECD TG 429, GLP), the stimulation indices (SI values) were 1.01 (5%), 1.03 (10%), and 1.38 (25%) (REACH registration dossier (Accessed May 2021)). (2) In a local lymph node assay (LLNA) with mice (n=5/group) (OECD TG 429, GLP), the stimulation indices (SI values) were 1.22 (0.5%), 1.29 (5%), and 3.00 (50%). It was reported that, at the highest dose level (50%), values equivalent to the threshold (SI value: 3) were obtained, but an increase in ear weight together with erythema on the skin was observed in the 50% dose group, and it was ambiguous whether this substance elicited a sensitizing response (REACH registration dossier (Accessed May 2021)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There were no in vivo findings and classification was not possible due to lack of data. [Reference Data, etc.] (1) In a bacterial reverse mutation study, weakly positive results were obtained (REACH registration dossier (Accessed May 2020)). (2) In a gene mutation test using the mouse lymphoma cells, negative results were obtained (REACH registration dossier (Accessed May 2020)). (3) In a micronucleus study using the human lymphocytes, negative results were obtained (REACH registration dossier (Accessed May 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, since (1) was a screening test, it was not possible to judge that this substance had no reproductive toxicity. [Evidence Data] (1) It was reported that, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422, GLP, for a total of 28 days from 2 weeks prior to mating (males), for 41 to 54 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum and during 5 days of lactation (females)), no reproductive toxicity was observed (REACH registration dossier (Accessed May 2021)). (2) It was reported that, in a developmental toxicity study (OECD TG 414, GLP, days 6-19 of gestation) with rats dosed by gavage, no developmental toxicity was observed (REACH registration dossier (Accessed May 2021)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2 (nervous system). [Evidence Data] (1) It was reported that, in an acute oral toxicity test with mice, decreased activity, dyspnea, and diarrhea were observed at 1,500 mL/kg (1,380 mg/kg, within the range for Category 2); and tremors, convulsions, and death were observed at 2,000 mL/kg (1,840 mg/kg, within the range for Category 2) (REACH registration dossier (Accessed May 2021)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was not sufficient information available for classification in other routes. [Evidence Data] (1) It was reported that, in an oral toxicity test with rats dosed by gavage (OECD TG422, GLP, males: for 28 days, females: for 41 to 54 days), no effects were observed at 240 mg/kg/day (converted guidance value: 74.7 mg/kg/day (males) and 109 to 144 mg/kg/day (females), within the range for Category 2) and hematological effects (prolonged blood coagulation time (APTT), decreases in erythrocyte count/hemoglobin/hematocrit) and forestomach effects (inflammation, erosion, edema) were observed at 720 mg/kg/day (converted guidance value: 224 mg/kg/day (males) and 328 to 432 mg/kg/day (females), in the range corresponding to "Not classified") (REACH registration dossier (Accessed May 2021)). (2) It was reported that, in a 13-week oral toxicity study with rats dosed by gavage (OECD TG408, GLP), no effects were observed at 150 mg/kg/day (in the range corresponding to "Not classified") but forestomach effects (epithelial hyperplasia, ulceration, inflammatory cell infiltration or inflammation) and glandular stomach effects (ulceration) were observed at 500 mg/kg/day (in the range corresponding to "Not classified") (REACH registration dossier (Accessed May 2021)).
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 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 62.2 mg/L for crustacea (Daphnia magna) (REACH (Accessed May 2021)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 3 because it is not rapidly degradable (BIOWIN) and it was classified in Category 3 in acute toxicity.
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.

To GHS Information