NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	107-64-2
Chemical Name	Dimethyldioctadecylammonium chloride (synonym: DODAC)
Substance ID	R03-B-005-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	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 (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.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (GESTIS (Accessed July 2021)).
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 (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 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)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen), which is chemically bonded to the element other than carbon or hydrogen (N), but it is ionically bonded and does not contribute to oxidization.
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	- -	-	-	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.

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), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (OECD TG 401) (SIAR (2002), EU RAR (2009)) [Reference Data, etc.] (2) LD50 (20% aqueous solution) for rats (males): 11,300 mg/kg (converted value: 2,260 mg/kg) (SIAR (2002), EU RAR (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2006)) (3) LD50 (20% aqueous solution) for rats (females): 13,000 mg/kg (converted value: 2,600 mg/kg) (SIAR (2002), EU RAR (2009), Initial Risk Assessment Report (NITE, CERI, NEDO, 2006))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (OECD TG 402) (SIDS (2002), EU RAR (2009))
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	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) It was reported that, in an acute dermal irritation/corrosion test with rabbits (n=3) (OECD TG 404, semi-occlusive, observation for 14 days), mild to moderate erythema reversed within 14 days but findings such as scales were observed after 14 days (erythema scores: 2/1/0.3) (EU RAR (2009), SIAR (2002)). [Reference Data, etc.] (2) It was reported that, in an acute dermal irritation/corrosion test with rabbits (n=6) (OECD TG 404, semi-occlusive, 4-hour application, 14-day observation ), the formulation containing 77% of this substance caused moderate irritation after application, and then the irritating effects increased and corrosiveness was seen at the end of the observation period (EU RAR (2009), SIAR (2002)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1), it was classified in Category 1. [Evidence Data] (1) It was reported that, in an acute eye irritation/corrosion test with rabbits (OECD TG 405), this substance posed a risk of serious damage to the eyes (EU RAR (2009), SIDS (2002)).
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] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in a patch test using the solution containing 0.033% of this substance with 1,719 dermatological patients affected with contact dermatitis (1100 patients with inflammation of the skin, 619 patients with mild cutaneous or mucosal manifestations), who were housewives or professional cleaners who used household detergent, no positive reaction was observed (EU RAR (2009)). (2) It was reported that, in a patch test using the formulation containing 0.82% of this substance with 127 volunteers (occlusive, 24 hours, 9 applications in 3 weeks), when a challenge was performed after 17 days, there were few irritation responses and no delayed contact hypersensitivity due to the challenge was observed (EU RAR (2009)). (3) It was reported that, in a maximization test (OECD TG 406, GLP) with guinea pigs, no skin sensitization was observed (EU RAR (2009), SIDS (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2006)). (4) It was reported that, based on the results of a human patch test and a test using guinea pigs, it could be concluded that this substance did not induce skin sensitization on humans (EU RAR (2009), SIAP (1996)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for in vitro, in a bacterial reverse mutation test, and a chromosome aberration test with the cultured mammalian cells (V79 cells), negative results were obtained (SIDS (2002), SIAP (1996), EU RAR (2009)). (2) An in vitro test result showed that there was no evidence or suggestion of a genotoxic potential of this substance (SIAP (1996), EU RAR (2009)). (3) The OECD and the EU concluded that there was no evidence of a genotoxic potential of this substance (SIAP (1996), EU RAR (2009)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification 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), it was classified in Category 2. [Evidence Data] (1) It was reported that, in a reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG421, 2 weeks before mating and 2 weeks including the mating period (males), 2 weeks before mating, through the mating and gestation periods until day 4 postpartum (females)), at 500 mg/kg/day, reduced body weight gain, dyspnea, soft stools, dilation of the abdomen (females), an increase in the number of days before mating, a lower pregnancy rate (6/9 rats), complete embryo resorption (1 rat), and a decrease in the number of dams which delivered litters (5/6 rats) were observed in parental animals, and a lower viability index on postnatal day 4 was observed in pups (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006), EU RAR (2009), SIAP (1997)). [Reference Data, etc.] (2) It was reported that, in a test with rats dosed by dermal application, no reproductive toxicity was observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2006), EU RAR (2009)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) It was reported that, in an acute oral toxicity test with rats (20% aqueous solution), depression of spontaneous movement, diarrhea, piloerection, and abdominal distention were observed, and the LD50 values were 2260 mg/kg (males) and 2600 mg/kg (females) (EU RAR (2009), SIAR (2002), Initial Risk Assessment Report (NITE, CERI, NEDO, 2006)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), in the oral route, since effects within the range for Category 1 and Category 2 could not be determined, classification was not possible. Besides, based on (2), in the dermal route, although it does not correspond to category 1, classification was not possible because effects within the range for Category 2 could not be determined. In the inhalation route, classification was not possible due to lack of data since there was no information on toxicity. Therefore, classification was not possible. [Evidence Data] (1) It was reported that, in a repeated dose 28-day oral toxicity study with rats (OECD TG 407, GLP), slightly reduced body weight gain, necroses of the adrenal cortex with infiltration of granulocytes and bleeding (females), ulceration of stomach mucosa (one female), and increased granulocyte count (males) were observed at 500 mg/kg/day (converted guidance value: 155.6 mg/kg/day, in the range corresponding to "Not classified") (EU RAR (2009), SIAR (2002)). (2) It was reported that, in a 4-week repeated dermal toxicity study with rabbits (5 days/week), slight local skin reactions were observed at the treatment site and no systemic toxicity was observed at 40 mg/kg/day (converted guidance value: 8.9 mg/kg/day, within the range for Category 1) (EU RAR (2009), SIAR (2002)).
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 ErC50 = 0.05 mg/L for algae (Raphidocelis subcapitata) (Initial Risk Assessment (NITE, CERI, NEDO, 2006)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it is not rapidly degradable (BIOWIN), and due to 96-hour NOEC = 0.006 mg/L for algae (Raphidocelis subcapitata) (SIAP (1996), SIDS (2002)).
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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