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 |
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 |
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. |
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. |
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. |
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