GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 93-83-4
Chemical name N,N-Bis(2-hydroxyethyl)oleamide
Substance ID 23A5176
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
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
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
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 - - - "Liquids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Liquids" according to GHS definition.
6 Flammable liquids Not classified - - - There are data of a flash point of 194 degrees C (open cup) (MSDS, Wako Pure Chemical Industries, Ltd. (Access on Jan. 2012)).
There are no data based on a prescribed test, but it was classified as "Not classified" because a flash point is judged to be roughly above 93 degrees C.
7 Flammable solids Not applicable - - - "Liquids" according to GHS definition.
8 Self-reactive substances and mixtures Classification not possible - - - There is a chemical group present in the molecule associated with a self-reactive property (unsaturated bond), but no data.
9 Pyrophoric liquids Classification not possible - - - No data.
10 Pyrophoric solids Not applicable - - - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible - - - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - It does not contain fluorine or chlorine but contains oxygen which is not chemically bonded to elements other than carbon or hydrogen.
14 Oxidizing solids Not applicable - - - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No data.

HEALTH HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - From an LD50 value of 12276 mg/kg for rats (NTP TR 481 (1999)), it was classified as "Not classified."
1 Acute toxicity (Dermal) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Liquids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - No data.
2 Skin corrosion/irritation Classification not possible - - - Lack of data.
Besides, List 3 data reported "moderate" irritation in a standard Draize test applied 300 micro L to rabbit skin without further details (RTECS (2005)).
3 Serious eye damage/eye irritation Classification not possible - - - No data.
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Classification not possible - - - No data.
5 Germ cell mutagenicity Not classified - - - From the information that a micronucleus test using peripheral blood after dermal administration to mice (in vivo somatic cell mutagenicity test) reported a negative (NTP DB (Access on Nov. 2011)), it was classified as "Not classified."
Besides, both an Ames test and a mouse lymphoma test of in vitro tests reported negatives (NTP DB (Access on Nov. 2011)).
6 Carcinogenicity Classification not possible - - - In a 2-year dermal administration test using rats and mice, non-neoplastic lesions of the skin as main effects including epidermal hyperplasia, sebaceous gland hyperplasia, hyperkeratosis, parakeratosis, chronic dermal inflammation, and the ulcer in both species were observed. But it was concluded that no evidence of carcinogenicity in this test conditions was found (NTP TR 481 (1999)).
However, it was classified as "Classification not possible" because dermal administration data only are not sufficient for carcinogenicity assessment of this substance in systemic effects.
7 Reproductive toxicity Classification not possible - - - No data.
8 Specific target organ toxicity - Single exposure Classification not possible - - - No data.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - In 13-week or 2-year repeated dermal administration tests in rats and mice (NTP TR 481 (1999)), lesions of the skin as main effects including hyperplasia, hyperkeratosis, dermatitis, the ulcer, and so on were observed, but any clear and systemic adverse effects were not reported.
The maximum doses up to 400 mg/kg/day in rats and 800 mg/kg/day in mice in the 13-week administration test correspond to "Not classified" in a dermal route.
But effects in other administration routes (oral, inhalation) are unknown due to no data.
Therefore, it was classified as "Classification not possible."
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
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 EC50 = 0.050 mg/L for crustacea (Daphnia magna) and so on (Results of Eco-toxicity tests of chemicals conducted by Environment Agency, 1999).
11 Hazardous to the aquatic environment (Long-term) Category 1

Warning
H410
P273
P391
P501
If chronic toxicity data are used, then it is classified in Category 1 due to no obtaining appropriate data on rapid degradability and 21-day NOEC = 0.057 mg/L for crustacea (Daphnia magna) (Results of Eco-toxicity tests of chemicals conducted by Environment Agency, 1999).
If acute toxicity data are used for a trophic level for which chronic toxicity data are lacking, then it is classified in Category 2 due to no obtaining appropriate data on rapid degradability and 96-hour LC50 = 1.5 mg/L for fish (Oryzias latipes) (Results of Eco-toxicity tests of chemicals conducted by Environment Agency, 1999).
It was classified in Category 1 by a comparison between the above results.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* 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.



Updated date:
2016/10/31 Addition of Rationale for the classification

List of GHS Classification Results