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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	124-30-1
Chemical Name	Octadecylamine; Monostearylamine
Substance ID	25A0079
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	- -	-	-	It is combustible, but the classification is not possible due to no data.
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	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 310 deg C for butylamine which has a shorter chain length than this substance (GESTIS (Access on December 2013)).
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	Not applicable	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	It was classified as "Not classified" (category 5 in UN GHS classification) based on an LD50 value of > 2,000 mg/kg for rats (EU-RAR (2008)). Besides, there is also a report on an LD50 value of about 1,000 mg/kg (PATTY (6th, 2012)), but it was not adopted for classification because its source was second source material.
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.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	It was classified in Category 2 because a skin irritation test (according to OECD TG 404) with rabbits is reported, the average scores after 72 hours for erythema and edema were 3.0 and 1.3, and most of the findings disappeared within 21 days (EU-RAR (2008)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It was classified in Category 2A because the Draize scores at 72 hours after application of this substance were 3.0 for conjunctival redness and 3.0 for chemosis in an eye irritation test with rabbits (according to OECD TG 405) (EU-RAR (2008)).
4	Respiratory sensitization	Classification not possible	- -	-	-	Respiratory sensitization: classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Skin sensitization: classification not possible due to lack of data. It is described in IUCLID (2000) that it was sensitizing in tests with rats and guinea pigs (OECD TG 404). However, because the details on positive rate, etc. are unknown, it was classified as "Classification not possible."
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 (EU-RAR (2008)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	After gavage administration to rats, reduced spontaneous activity, piloerection, hunched posture, abnormal gait, reduced activity, irregular breathing, etc., which were reversible, were observed at 2,000 mg/kg (EU-RAR (2008), BUA 177 (1994)). Therefore, it was classified in Category 3 (narcotic effects). And one animal died in the test, and necropsy revealed dark-colored liver, staining of the lung, intestine, and pancreas, shrunken spleen, and distended stomach and intestine (EU-RAR (2008)). However, these were not judged as effects on the specific organs because these were the necropsy findings observed in only one dead animal.
9	Specific target organ toxicity - Repeated exposure	Category 2 (gastrointestinal tract)	Warning	H373	P260 P314 P501	In a 1-year gavage (capsules) administration test with dogs, one out of three animals died after showing hemorrhagic diarrhea and anorexia at the dose (15 mg/kg/day) corresponding to Category 2. The other two showed reduced weight gain, and effects on the mesenteric lymph node (histiocytosis) and gastrointestinal tract (pale staining of the tips of the villi of the small intestine mucosa) were observed pathologically (EU-RAR (2008)). And in a 2-year diet administration test with rats, histiocytosis in the mesenteric lymph node was observed in one out of 12 animals at the dose (500 ppm; 27-28 mg/kg/day) corresponding to Category 2 (EU-RAR (2008)). These were not regarded as toxicity effects in PATTY (6th, 2012), but the opinion in EU-RAR (2008) was that these findings only in one rat were adverse effects on the basis that similar findings were observed in dogs. Furthermore, in the test with rats, accumulation of histiocytes in the small intestine mucosa and mesenteric lymph node was found in a high dose group (3,000 ppm; 88 mg/kg/day (males, Category 2), 138 mg/kg/day (females, "Not classified")) (EU-RAR (2008), PATTY (6th, 2012)). Therefore, in both rats and dogs, effects on the gastrointestinal tract (hemorrhagic diarrhea, histological changes in the small intestine mucosa) and mesenteric lymph node were observed within the guidance value range for Category 2, but histiocytosis in the mesenteric lymph node was thought to be secondary changes (local immune responses) induced by irritation effects on the small intestine mucosa, and it was judged to be inappropriate to adopt the immune/lymphatic organs as the target organs. On the other hand, the toxicological significance of the histological changes in the small intestine mucosa is unknown, but it was classified in Category 2 (gastrointestinal tract) based on the EU's opinion that these were the adverse effects.
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 1	Warning	H400	P273 P391 P501	From 72-hour ErC50 = 0.12 mg/L for algae (Desmodesmus subspicatus) (EU-RAR, 2007), it was classified in Category 1.
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 2 due to rapid degradability (a degradation rate by BOD: 70-75% (EU-RAR, 2007)), and 72-hour ErC10 = 0.029 mg/L for algae (Desmodesmus subspicatus) (EU-RAR, 2007). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to rapid degradability (a degradation rate by BOD: 70-75% (EU-RAR, 2007)), and 48-hour EC50 = 0.13 mg/L for crustacea (Daphnia magna) (EU-RAR, 2007). By drawing a comparison between the above results, it was classified in Category 1.
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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