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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	7173-51-5
Chemical Name	Didecyldimethylammonium chloride
Substance ID	25B0062
Classification year (FY)	FY2013
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2012
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solid	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	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 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 applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	It is an organic compound which does not contain fluorine or oxygen but contains chlorine, and the chlorine is a chlorine ion ionically bonded to quaternary ammonium and does not contribute to oxidization.
15	Organic peroxides	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.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	It was classified in Category 3 based on reports on an LD50 value for rats of 238 mg/kg for 80% active ingredient (a converted value equivalent to pure substance: 190.4 mg/kg) (EPA Pesticide RED (2006), HPVIS (2009)) and an LD50 value for rats of 262 mg/kg for 65% active ingredient (a converted value equivalent to pure substance: 170.3 mg/kg) (EPA Pesticide RED (2006), HPVIS (2009)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" (Category 5 in UN GHS classification) based on reports on an LD50 value for rats of 2,930 mg/kg for 65% active ingredient (a converted value equivalent to pure substance: 2,344 mg/kg) (EPA Pesticide RED (2006), HPVIS (2009)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there are reports on an LC50 value of 0.07 mg/L for rats (EPA Pesticide RED (2006), HPVIS (2009)), but it was not adopted because the exposure time is unknown.
2	Skin corrosion/irritation	Category 1C	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	In a test by 4-hour application to the skin of one rabbit, signs of severe irritation persisted for 24 hours, coriaceousness, blanching, and necrosis of the skin were observed, and the test was stopped because corrosivity was confirmed at the observation 24 hours after the application. As a result, this substance was assessed to be corrosive to the rabbit skin (HPVIS (2009)). Therefore, it was classified in Category 1C. This substance was classified in "C; R34" in EU DSD classification and "Skin Corr. 1B H314" in EU CLP classification.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	Extreme corneal opacity, iritis, and conjunctival irritation occurred 1 hour after the application to the eye of one rabbit, and the eye appeared misshapen. The total irritation score was 94 (maximum 110). Due to the evidence of corrosion, the test was stopped after 1 hour, and this substance was assessed to be corrosive to the rabbit eye (HPVIS (2009)). Therefore, it was classified in Category 1.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	It was classified in Category 1 because it is listed as a contact allergen in Contact Dermatitis (5th, 2011). Besides, it is reported that a positive rate of 0% (0/20) was shown in a skin sensitization test with guinea pigs (Buehler test), and this substance was not a sensitizer (HPVIS (2009)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a chromosomal aberration test with rat bone marrow cells (HPVIS (2009)). As for in vitro, it was negative in all of a bacterial reverse mutation test (HPVIS (2009), HSDB (Access on May 2013)), a chromosomal aberration test and a gene mutation test with cultured mammalian cells (HPVIS (2009)).
6	Carcinogenicity	Classification not possible	- -	-	-	EPA classified this substance as not likely to be a human carcinogen based on the lack of evidence of carcinogenicity in mice or rats (EPA Pesticides (2006)). However, it was classified as "Classification not possible" because no information clearly shows that it is not carcinogenic.
7	Reproductive toxicity	Classification not possible	- -	-	-	As for fertility, in a two-generation reproductive toxicity test with rats in the oral route (feeding), no fertility effects were seen at the dose that caused toxicity in parent animals (decreased body weights, decreased weight gain, decreased food consumption), but decreases in body weights and weight gain were observed in offspring on days 21 and 28 after birth. As for developmental toxicity, in a developmental toxicity test with rabbits in the oral route (gavage), developmental toxicity (increased fetal mortality, reduced fetal body weights) was found at the dose where maternal toxicity was seen (decreased weight gain, hypoactivity, labored respiration, death (4/16 animals)). In a developmental toxicity test with rats in the oral route (gavage), no developmental toxicity was observed even at the doses that produced maternal toxicity (HPVIS (2009)). No fertility effects were found, but developmental toxicity was not found, or found at the dose where maternal animals died. Therefore, it was classified as "Classification not possible" due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 1 (systemic toxicity)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In an acute oral toxicity test with rats (100-400 mg/kg), symptoms of sluggishness, lacrimation, diarrhea, and emaciation occurred, and necropsy of dead animals showed discolored and hemorrhaged stomachs, red to brown intestines, and dark red livers (HPVIS (2009)). And in another acute oral toxicity test with rats (doses: 100-500 mg/kg), urine and fecal stains, saliva discharge, piloerection, ataxia, body tremors, labored respiration, slight to severe depression, spasms in the abdominal area, etc. are reported as major clinical signs (HPVIS (2009)). The above findings appeared at the doses corresponding to the guidance value range for Category 1, but it was difficult to specify the target organ, therefore it was classified in Category 1 (systemic toxicity). Besides, Category 2 (systemic toxicity) in the previous classification was changed to Category 1 (systemic toxicity) because HPVIS was listed in List 1 according to the revised GHS classification guidance for the Japanese government.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In diet administration tests in rats for 13 weeks, or mice for 78 weeks, only decreases in body weights and weight gain were observed in both species at the doses (155.5-255.5 mg/kg/day) above the range for Category 2, and in rats, histological findings were also found in the liver and mesenteric lymph nodes (HPVIS (2009)). And in a 1-year oral administration test with dogs, only digestive symptoms estimated to be caused by irritation of the gastrointestinal tract (emesis, soft or mucoid feces) were seen at the doses (20-30 mg/kg/day) within the guidance value range for Category 2, there were no organs that showed abnormalities in histopathological examination (HPVIS (2009)), and it was estimated that there were no findings to assign the category. On the other hand, in the dermal route, it is described that as a result of a 13-week dermal application to rats, effects of skin irritation such as hyperkeratosis, acanthosis, and ulceration were observed at the application sites, but no systemic effects were found (HPVIS (2009)), however, this test was judged as inappropriate for classification because the doses did not cover the guidance value range. From the above, it corresponds to "Not classified" in the oral route, but toxicity information on the other routes is insufficient. Therefore, it was classified as "Classification not possible" due to lack of data. Besides, the previous classification was conducted based on the results of a 104-week diet administration test with rats (USEPA HPV (2005)) and an 8-week oral administration test with dogs (HSDB (2010)), but these tests were not used this time because the former test was removed from the assessment targets in the EPA's assessment that came after that (HPVIS (2009)), and the latter was judged as inappropriate for classification due to being a preliminary test for the 1-year oral administration test with dogs mentioned above and using the small number of animals (n = 2). Therefore, the classification result was changed.
10	Aspiration hazard	Classification not possible	- -	-	-	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 (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour LC50 = 0.034 mg/L for crustacea (Daphnia magna) (ECETOC TR91, 2003).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because appropriate data on rapid degradability were not obtained, and it was classified in Category 1 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.

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