GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 683-10-3
Chemical Name 2-(N-Dodecyl-N,N-dimethylammonio)acetate
Substance ID H27-A-060/C-138A_P
Classification year (FY) FY2015
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/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 (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

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 present in the molecule associated with explosive properties.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - "Solids" according to GHS definition.
3 Aerosols Not applicable
-
-
- - Not an aerosol product.
4 Oxidizing gases Not applicable
-
-
- - "Solids" according to GHS definition.
5 Gases under pressure Not applicable
-
-
- - "Solids" according to GHS definition.
6 Flammable liquids Not applicable
-
-
- - "Solids" according to GHS definition.
7 Flammable solids Classification not possible
-
-
- - Due to no data, the classification is not possible.
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
-
-
- - "Solids" according to GHS definition.
10 Pyrophoric solids Classification not possible
-
-
- - Due to no data, the classification is not possible.
11 Self-heating substances and mixtures Classification not possible
-
-
- - Due to no data, the classification is not possible.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable
-
-
- - Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable
-
-
- - "Solids" according to GHS definition.
14 Oxidizing solids Not applicable
-
-
- - It is an organic compound which contains oxygen, and the oxygen is not chemically bonded to the elements other than carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- - It is an organic compound that does not contain bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No established test method suitable for solid substances.

HEALTH HAZARDS
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
From a reported LD50 value (OECD TG 423) of 300 to 2,000 mg/kg for rats (Japan Existing Chemical Data Base, Ministry of Health, Labour and Welfare (Access on October 2015)), it was classified in Category 4.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
2 Skin corrosion/irritation Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
3 Serious eye damage/eye irritation Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Respiratory sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
4 Skin sensitization Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
5 Germ cell mutagenicity Classification not possible
-
-
- - The classification is not possible due to lack of data. Namely, there are no in vivo data, and as for in vitro, a bacterial reverse mutation test and a chromosomal aberration test in cultured mammalian cells were negative (Japan Existing Chemical Data Base, Ministry of Health, Labour and Welfare (Access on October 2015)).
6 Carcinogenicity Classification not possible
-
-
- - Due to lack of data, the classification is not possible.
7 Reproductive toxicity Classification not possible
-
-
- - In a combined repeated dose toxicity study with reproduction/developmental toxicity screening test (OECD TG 422) using rats, prolongation of gestation period and a decrease in a number of pups born were observed in maternal animals at 300 mg/kg/day where general toxic effects were apparent in parent animals (deaths (females 2/12), tissue injury in kidney and bladder (60 mg/kg/day or higher), tissue injury in forestomach and so on). However, out of death cases, one died at the end of gestation, and the other died during parturition, and it was considered that both perinatal deaths and difficult parturition were attributed to severe general toxic effects in maternal animals which resulted in prolongation of gestation period and a decreased number of pups born (Japan Existing Chemical Data Base, Ministry of Health, Labour and Welfare (Access on October 2015)). Moreover, it is thought that they were not reproductive effects specifically related to administration of this substance. Namely, reproductive/developmental effects related to administration of this substance were not detected in this test, but it cannot be classified as "Not classified" only by this result because it is a screening test, and there are no other data available. Therefore, the classification is not possible due to lack of data in this hazard class.
8 Specific target organ toxicity - Single exposure Category 2 (gastrointestinal tract)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
There are no human data. As for experimental animals, decreased spontaneous motility, irregular breathing, and gastrointestinal tract disorder (distension of the stomach and small intestine, reddening in the mucous membrane of the glandular stomach, accumulation of red and clear ascitic fluid) were reported after oral administration in rats (2,000 mg/kg, corresponding to Category 2) (Japan Existing Chemical Data Base, Ministry of Health, Labour and Welfare (Access on October 2015)).
From the above, because gastrointestinal tract disorder was observed for this substance, the substance was classified in Category 2 (gastrointestinal tract).
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney, urinary bladder)


Warning
H373 P260
P314
P501
There is no human information.
As for experimental animals, in a combined repeated dose toxicity study with reproduction/developmental toxicity screening test using rats in gavage administration, necrosis of tubular epithelium and hyperplasia of pyelic epithelium in the kidney and hyperplasia of mucous membrane epithelium in bladder were observed at 60 mg/kg/day within a range of Category 2 (converted to a 90-day equivalent: males 28 mg/kg/day) (Japan Existing Chemical Data Base, Ministry of Health, Labour and Welfare (Access on October 2015)).
Therefore, the substance was classified in Category 2 (kidney, bladder).
10 Aspiration hazard Classification not possible
-
-
- - Due to lack of data, the classification is not possible.

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
From 96-hour LC50 = 0.88 mg/L for fish (Oryzias latipes) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2004), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 3
-
-
H412 P273
P501
If chronic toxicity data are used, then it is classified in Category 3 due to rapid degradability (a degradation rate by 28-day O2 consumption/BOD = 96%, a degradation rate by TOC removal = 98%, a degradation rate by HPLC = 100% (Official Bulletin of Economy, Trade and Industry, 2004) and a degradation rate by 28-day BOD (NH3) = 96%, a degradation rate by HPLC = 100% (Official Bulletin of Economy, Trade and Industry, 2004)), 21-day NOEC (reproduction) = 0.29 mg/L for crustacea (Daphnia magna) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2005).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" due to rapid degradability, and a low bioaccumulation estimate (log Kow = 0.47 (PHYSPROP Database, 2009)) although 96-hour LC50 = 0.88 mg/L for fish (Oryzias latipes) (Results of Eco-toxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2004).
It was classified in Category 3 by drawing a comparison between the above results.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data.


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.

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