GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 61789-40-0
Chemical Name Inner salt of N-cocoacyl derivatives of (3-aminopropan-1-yl)(carboxymethyl)dimethylammonium
Substance ID 25A0084
Classification year (FY) FY2013
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 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
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
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 4


Warning
H302 P301+P312
P264
P270
P330
P501
There is a report on two LD50 values for rats of about 1,530 mg/kg and 2,370 mg/kg (SIDS (2012)), which correspond to Category 4 and "Not classified." It was classified in Category 4 to which the minimum LD50 value corresponded.
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there is a report on an LD50 value of > 2,000 mg/kg for a 31% aqueous solution (a converted value equivalent to active substance: > 600 mg/kg) (SIDS (2012)).
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.
2 Skin corrosion/irritation Not classified
-
-
- - Many skin corrosion tests with rabbits according to the OECD TG 404 are reported, and there was slight irritation in all of them (SIDS (2012)). Therefore, it was classified as "Not classified."
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
Many eye irritation/corrosion tests with rabbits (according to the OECD TG 405) are reported, and it was assessed to be moderately irritating in all of them, but it is described that effects on the iris and conjunctiva did not disappear within 21 days (SIDS (2012)). Therefore, it was classified in Category 1.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - In SIDS (2012), there are results from four skin sensitization tests with guinea pigs (a maximization test, a Draize test, etc.), and three of them gave negative results. Positive responses were observed in 4 out of 20 animals only in one test, and it is pointed out in SIDS (2012) that the results were caused by impurities. And it is described that the sensitizing potential is low in humans. It was classified as "Not classified" based on the above results.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. There are no in vivo data, and as for in vitro, it was negative in a bacterial reverse mutation test (IUCLID (2000)).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a developmental toxicity test with rats in the oral route (gavage) (OECD TG414), maternal toxicity (death (1/21 animals died on gestation day 15), abdominal position (13/21), piloerection (2/21), reduced motility, reduced body weights (up to 17% below control group), ulcers (2/21) and thickened mucosa (20/21) in the stomach) was observed at 3,300 mg/kg/day (equivalent to active substance 950 mg/kg/day), where increased resorptions, decreased live fetuses, and decreased body weights of fetuses were found. Besides, at 990 mg/kg/day, one dose lower (equivalent to active substance 286 mg/kg/day), maternal toxicity was seen, but no effects on the development of offspring were observed (SIDS (2012)). As described above, effects on fetuses were found only at the dose where effects on maternal animals were seen, therefore it was classified in Category 2. Besides, no fertility data were obtained.
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects)


Warning
H336 P304+P340
P403+P233
P261
P271
P312
P405
P501
In an oral administration test with rats, the animals showed decreased motor activity, coordination disturbance, abnormal body posture, and piloerection, which were reversible at the doses (5-10 g/kg) above the guidance value range (SIDS (2012)). Therefore, it was classified in Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - In a 90-day gavage administration test with rats, only tissue changes in the forestomach (males and females) at the dose (150 mg/kg/day) above the guidance value range for Category 2 and increased incidence of positive reactions for hemoglobin concentration (males) at the highest dose (300 mg/kg/day) were observed (SIDS (2012)). Therefore, it corresponds to "Not classified" in the oral route. However, because of no toxicity information on the other routes, it was classified as "Classification not possible" due to lack of data.
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 2
-
-
H401 P273
P501
From 72-hour ErC50 = ca. 1.3 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2012), it was classified in Category 2.
11 Hazardous to the aquatic environment (Long-term) Category 2


-
H411 P273
P391
P501
It was classified in Category 2 due to rapid degradability (a degradation rate by BOD: 86-93% (SIDS, 2012)), and 72-hour NOEC = ca. 0.09 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2012).
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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