NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	106-31-0
Chemical Name	Butyric anhydride
Substance ID	m-nite-106-31-0_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	The flash point 88 degC (190 degF) (open-cup) was obtained (Merck (14th, 2006)) and it is estimated that the flash point measured by the closed-cup method fall within the range of > 60 degC and <= 93 degC. Based on these information, the substance was classified into Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	Since its autoignition temperature is 279 degC (535 degF) (HSDB (2002)), it is considered that the substance does not ignite at room temperature.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance contains oxygen which is chemically bonded only carbon or hydrogen.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Classification not possible	- -	-	-	No data were available. As relevant information, the rat LD50 values of 8790, 2940 and 2000 mg/kg bw were reported (all from PATTY, 5th (2001)) for normal butyric acid. [For health hazards, refer also to n-butyric acid (CAS; 107-92-6) as the hydrolysate of the substance.]	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data were available. As a relevant note, the rabbit LD50 value of 530 mg/kg bw was reported (PATTY, 5th (2001)) for n-butyric acid.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data were available. As a relevant note, it was reported that the exposure of 2.4 mg/L/8hrs (saturated vapor) of n-butyric acid to rats caused no death.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	It was described in the human case that the substance caused skin irritation by contact with vapor (HSDB (2002)). And as for the information of n-butyric acid it was reported that in the guinea pig test (occlusive application with 10mg for 24 hours, non-occlusive application with 500mg for 24 hours), severe reactions were observed (PATTY, 5th (2001)). And it was also reported that in the rabbit test (OECD TG404, GLP-compliant), corrosive effects were observed (IUCLID (2000)). Based on these documents, the substance was classified as Category 1.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	The substance caused eye irritation by contact with vapor in the human case (HSDB (2002)). As for the information of n-butyric acid, it is reported that instillation of aqueous solution more than 5% caused severe corneal burns in the rabbit test (PATTY, 5th (2001)). Based on the documents, the substance was classified as Category 1.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	The classification was not possible due to lack of data. As relevant information, it was reported that n-butyric acid caused no skin sensitization for human (subcutaneous injection, 2 weeks, the index of sensitization were infiltration of leukocytes or eosinophils) (PATTY, 5th (2001)). Since it was not conducted in accordance with standard protocol, the result was not adopted as the basis of the classification.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	No data were available. As relevant information, as for in vitro studies, negative results were reported in the Ames test and chromosome aberration test for n-butyric acid (PATTY, 5th (2001)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data were available. As relevant information, as for the information of n-butyric acid, in the oral administration study using pregnant rat during the organogenetic period, maternal mortalities were high, and maternal body weight gain was markedly suppressed, but no effects on progeny were reported (PATTY, 5th (2001)). However, there was no information for reproductive toxicity.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (lung)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	No data were available for the substance (anhydrate). It was reported that single exposure to n-butyric acid aerosol to rabbits at the concentration of 40 mg/L/1.5hrs (converted value as that of 4-hour exposure: 15 mg/L/4hrs: over the range of Category 2 of the guidance values) caused signs of bronchitis and emphysema (PATTY, 5th (2001)). It was also reported that another inhalation study in rabbits exposed to the concentration of 0.4 mg/L/1.4hrs (converted value as that of 4-hour exposure: 0.24 mg/L: within the range of Category 1 of guidance value) revealed congestion, edema, atelectasis and emphysema of the lungs (IUCLID (2000)). According to the latter information, Category 1 (lung) was judged as relevant. However, because the information was obtained from the "List 2" information source designated in the GHS classification guidance for the Japanese government, the substance was classified as Category 2 (lung).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	No data were available for the substance (anhydrate). As relevant information, as for the information of n-butyric acid, it was reported that the suppression of body weight gain, and papillomatosis and hyperkeratosis of gastric tissues were observed in the oral study in rats (feeding study, up to 35 weeks, dose levels were unknown) (PATTY, 5th (2001)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 3	- -	H402	P273 P501	This substance is thought to be rapidly hydrolyzed into n-butyric acid (CAS No. 107-92-6) in water (the half-life in water = 1.679 minutes (pH = 8), 16.789 minutes (pH = 7) (HYDROWIN)). Although there are no data available on butyric anhydride, the substance is classified into Category 3 from 72h-EC50 of n-butyric acid = 46.7 mg/L (26 mg/L as butyric anhydride) for algae (Scenedesmus subspicatus) (IUCLID, 2000).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	This substance is thought to be rapidly hydrolyzed into n-butyric acid (CAS No. 107-92-6) in water (the half-life in water = 1.679 minutes (pH = 8), 16.789 minutes (pH = 7) (HYDROWIN)). This substance is classified as "Not classified" since n-butyric acid is rapidly degradable (28d-degradation rate tested by OECD TG301C: > 60% (IUCLID, 2000)) and it is estimated not to be bioaccumulative (LogPow = 1.24 (PHYSPROP Database, 2011)) though its acute toxicity is Category 3.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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