GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 1643-20-5 |
| Chemical Name | N,N-Dimethyldodecylamine N-oxide |
| Substance ID | H27-B-07-METI/M-016B_P |
| Classification year (FY) | FY2015 |
| 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 | FY2007 FY2006 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 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 | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (N-oxides) present in the molecule, and the calculated oxygen balance (value: -296) is less than the criteria: -200. However, because there are no data on exothermic decomposition energy and onset temperature, the classification is not possible. |
| 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 solids | Classification not possible |
- |
- | - | No data available. |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (N-oxides) present in the molecule, but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Classification not possible |
- |
- | - | Because its use is surfactant, it is estimated that it does not ignite in contact with the air at normal temperatures, but the classification is not possible due to no data. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | 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 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 | Classification not possible |
- |
- | - | It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (N). However, the classification is not possible due to no data. |
| 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 4 |
 Warning |
H302 | P301+P312 P264 P270 P330 P501 |
Based on a reported LD50 value of 1,267 mg/kg for rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)), it was classified in Category 4. Based on the high priority information, the category was revised. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there is a report that the LC50 value (4 hours) was 5.3 mg/L (a converted value equivalent to this substance: 0.016 mg/L) when rats were exposed by inhalation to the mist of a hair spray containing 0.3% of this substance (water: 85-95%, PVP/VA copolymer: 1-5%, cocamide DEA: 0-2%, polyquaternium-11: 0-2%, other: <1%) (SIDS (2007)). However, the category cannot be specified only with this data. Besides, based on the description that the hair spray was supplied by aerosol in the test, a reference value of mist was applied. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, there is a report that in a skin irritation test with rabbits, severe irritation was observed as a result of the application of this substance for 24 hours (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), HSDB (Access on October 2015)), but this was not used for the classification because it was a test of application for 24 hours. |
| 3 | Serious eye damage/eye irritation | Category 2A |
Warning |
H319 | P305+P351+P338 P337+P313 P264 P280 |
There is a report that in an eye irritation test with rabbits, severe irritation was observed after a 1% solution of this substance was applied (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). In other eye irritation tests with rabbits, it is reported that mild irritation was observed by applying this substance at 30% and no irritation was observed by the application of this substance at 0.3% (SIDS (2007)). It is reported in SIDS (2007) that oxidized amine compounds including this substance do not show any irritation at low concentrations, but severe irritation was seen at around 30% concentration (SIDS (2007)). From the above, based on the report that severe irritation was observed, it was classified in Category 2A. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Not classified |
- |
- | - | There is a report that no sensitization was observed in the maximization test with guinea pigs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)), and there are multiple reports that in patch test reports on human (84, 101, 141 subjects), no sensitization was seen (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). It was concluded in SIDS (2007) that this substance did not show sensitization (SIDS (2007)). From the above, it was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo, a mouse dominant lethal test was negative. As for in vitro, bacterial reverse mutation tests were negative (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). Therefore, it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | In carcinogenicity tests in which female and male rats were orally dosed (drinking water) with this substance at 1,000 ppm for 93 weeks, a combined administration group of 1,000 ppm of this substance and 2,000 ppm of sodium nitrite, in addition to the 1,000 ppm dose group of this substance alone, was set, and the presence or absence of carcinogenicity was compared. As a result, no evidence of an increase in tumor incidence was shown in the single administration group compared with the untreated control group, whereas in the combined group of this substance and sodium nitrite, an increased incidence of liver tumors (hepatocellular adenoma) was observed when compared with the group dosed with sodium nitrite alone (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). Other than this, there are reports of a 2-year feeding study with rats and a 2-year dermal application test with mice using the test substance (C10-16 AO (CAS RN: 70592-80-2)), which is a 27% aqueous solution product which is a commercially available product of alkyldimethyl N-aminoxide (AO), and contains 95% or above of C10-C16 linear alkylaminoxide and C12 as the main component. In the high-dose group, it was administered at up to the doses where a decreased body weight gain was seen in the feeding test and where a thickening of skin due to skin irritation was seen in the dermal application test. And neither showed evidence of carcinogenicity (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). From the above, there was no evidence of carcinogenicity either for rats in the oral route (drinking water) of this substance, or for rats in the oral route, or for mice in the transdermal route of a commercially available aqueous solution containing this substance. In drinking water administration in rats, an increased incidence of hepatocellular adenoma in the liver was observed when this substance and the nitrite were dosed concomitantly. It is difficult to evaluate the carcinogenicity of this substance from the result of the combined administration with a nitrite, and it is considered that the possibility of carcinogenicity in this substance itself is low from the result of the single administration. However, there is only one report from a test of dosing this substance of certain purity and this is the drinking water administration (1,000 ppm) in rats. The information on such as dose response relationship and the difference between animal species is missing, so it is not possible to classify due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a two-generation reproductive toxicity test in which this substance was administered orally (feeding) to rats, since a reduced body weight was seen 6.5 weeks after starting administration to F0 parent animals, the doses were reduced; the parent animals of F0 and F1 generations were dosed at doses equivalent to 11-40 mg/kg/day and the test was continued until the weaning of the F2 pups. As a result, a suppressed weight gain was observed in the parent animals, but there were no adverse effects on fertility and in the pups of F1 and F2, only a transition of low body weight during the lactation period was seen from the low dose group (SIDS (2007)). As for a developmental toxicity study, in a study in which this substance was administered by gavage to pregnant rats at up to 200 mg/kg/day on gestational days 7-17, 2/3 of animals were caesarean sectioned on day 20 of gestation, the fetuses of which were observed; the remaining animals were allowed to deliver naturally, F1 animals were mated with each other at 10 weeks of age after breeding, and sacrificed on day 20 of gestation, a suppressed body weight gain (slightly, <10%) and a decreased water consumption at 200 mg/kg/day in F0 maternal animals, a reduction of the placenta weight at 200 mg/kg/day in F1 maternal animals, and a reduced fetal body weight and an ossification delay at 200 mg/kg/day in fetuses (F1) were observed (SIDS (2007)). Similarly, in a test in which this substance was administered by gavage to pregnant rabbits at 40-160 mg/kg/day on gestational days 6-18, suppressed body weight gain and decreased food and water consumption at or above 40 mg/kg/day in maternal animals were observed, and at 80 and 160 mg/kg/day, each 3 cases were dead or euthanized due to moribundity, but no abnormalities were observed in fetuses of the surviving animals (SIDS (2007)). As described above, in the reproductive and developmental toxicity tests by the oral route of this substance, there were no adverse effects on the fertility of the parent animals and only minimal developmental effects were seen in the fetuses or pups at doses where maternal toxicity was manifested. No toxicity information available for classification was obtained, and it was judged that information was insufficient to classify it as "Not Classified." Therefore, it was classified as "Classification not possible" due to lack of data for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. As for the test report in which this substance was administered, there is only the test report of drinking water administration (0.1%) with rats shown below. The information such as the dose response relationship and difference between animal species is missing. Therefore, it could not be classified due to lack of data. No toxic effects were observed in a test in which 0.1% of this substance (equivalent to 250 mg/kg/day) was administered by drinking water to rats for 93 weeks (SIDS (2007)). Other than this, in a 104-week feeding study, although it is not an administration of this substance alone, an aqueous solution product containing 27% of alkyldimethylamine oxides (AO, alkyl chain length C12-C16, and dodecyl (C12) as a main component) (however, the proportion of DDNO contained in AO is unknown) administered to rats showed a suppressed body weight gain, observed in females and males in the 0.2% administration group (100 mg/kg/day as AO). In addition, in a 104-week study in which the same aqueous solution product containing 27% of alkyldimethylamine oxides (AO, alkyl chain length C12-C16, dodecyl (C12) as a main component) was dermally administered to mice, thickening of the skin was observed, but no systemic toxicity was seen (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), Environmental Risk Assessment for Chemical Substances Vol.5, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). In a study in which the product containing 0.3% of this substance was applied to rabbits at 2 mL/kg/day, 5 days/week for 4 weeks, there were only local effects at the application site, and systemic toxicity was not observed (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), SIDS (2007)). |
| 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 |
From 72-hour EC50 = 0.1 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 | P273 P391 P501 |
Due to being not rapidly degradable (4-week BOD: 54, 52, 82%, TOC: 68, 54, 81%, LC-MS: 100, 100, 100% (Official Bulletin of Ministry of International Trade and Industry, 1995)), and 72-hour NOEC (r) = 0.004 mg/L for algae (Pseudokirchneriella subcapitata) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), it was classified in Category 1. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
| * A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |