NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1402-68-2
Chemical Name	Aflatoxins
Substance ID	m-nite-1402-68-2_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 molecules.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
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)	Category 2	Danger	H300	P301+P310 P264 P270 P321 P330 P405 P501	Based on aflatoxin B1 LD50 values of 7.2 mg/kg bw (male) and 17.9 mg/kg bw (female) for rats (EHC 11 (1979)), the substance was classified into Category 2. This substance (Aflatoxins: CAS 1402-68-2) consists of Aflatoxin B1, B2, G1, G2, M1 etc. whose molecular structures slightly differ from each other. Hazard classification was principally based on the data of the most toxic Aflatoxin B1.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (room temperature)	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	For aflatoxin B1, there are data of positive results in a gene mutation test using rat splenic lymphocytes HPRT locus, rat bone marrow micronucleus test and both mouse and rat bone marrow chromosomal aberration tests (IARC 82 (2002)). However, there are data of negative results in a mouse bone marrow micronucleus test and a transgenic mouse gene mutation test (IARC 82 (2002)). Since positive results are obtained from in vivo somatic cells mutagenicity tests but no information of in vivo germ cell mutagenicity test are available, the substance was classified into Category 2. As relevant information, from in vitro mutagenicity tests, there are reports of positive results in Ames tests (NTP DB (access on Sep. 2009)), gene mutation tests and micronucleus tests using somatic cells (IARC 82 (2002)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	Based on the classification of "Group 1" in IARC (IARC 56 (1993)), the substance was classified into Category 1A. In a test where rats were administered in diet for approximately 1-year, a linear dose-response relationship was observed in the incidence of hepatomas (IARC 56 (1993)). Additionally, there are many reports of positive results (mainly increased incidence of hepatocellular carcinomas) for tests of cancer in experimental animals (IARC 56 (1993)).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	There is a report that in a rat test by subcutaneous injection of 0.3 mg/kg on gestation days 11 - 14 or 15 - 18, the exposure produce effects on pups such as decreased number of live pups and impaired learning ability (early exposure appeared to produce more effects than later exposure) but no effects on maternal body weight (IARC 82 (2002)). Information from a mouse test by oral intubation on day 8 or 9 of pregnancy with 4 mg/kg, indicate that fetal anomalies (exencephaly: 4, open eyes: 3, protrusion of intestines: 2) were observed in 7/61 fetuses exposed on day 8 (IARC 56 (1993)). Additionally, it was reported that aflatoxin exposure to pregnant women in Kenya was associated with reduced birth rates and malformation and the substance is classified into teratogenic agent in Catalog of Teratogenic agents (11th ed, Johns Hopkins Univ. Press (2004)). The substance was classified into Category B.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
8	Specific target organ toxicity - Single exposure	Category 1 (liver)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In a monkey test by single oral administration, at a dose of 1.8 mg/kg, 5 animals died and showed centrilobular necrosis, biliary proliferation and fibrosis, 2 animals survived, one of which showed nodular cirrhosis after 3 years (EHC 11 (1979)). In another monkey test by single oral administration, all animals died within 149-hour at doses of 13.5 mg/kg and higher. Liver lesions included centrilobular necrosis and cerebral oedema with neuronal degeneration were observed (EHC 11 (1979)). In a rabbit dermal administration test, liver lesions such as midzonal necrosis were seen in 8/10 treated rabbits at >1.4 mg/kg (IARC 56 (1993)). For other organs besides the liver, in a rat acute oral toxicity test, adrenal haemorrhages, congested lungs and patchy necrosis in the myocardium, kidney and spleen were observed (EHC 11 (1979)). These effects were observed at dose levels within the guidance value range for Category 1. Additionally, intoxicated cases of children of hepatic encephalopathy in Malaysia were reported (IARC 82 (2002)). In 7 children cases from who aflatoxins were found in blood and organs after consumption of Chinese rice noodles, liver dysfunction with elevated serum concentrations of hepatic enzymes was observed (IARC 82 (2002)). Based on above information, the substance was classified into Category 1. The liver is regarded as a target organ since there were no finding in other organs besides the liver for rabbits (IARC 56 (1993)) and there is a report that fatty degeneration of the liver was the most consistent pathological finding in monkey tests (EHC 11 (1979)) while cerebral oedema was observed in one test.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	In a repeated dose test with monkeys, at a dose level of 1 mg/kg, 35/35 animals died within 22 days with extensive haemorrhagic necrosis of the liver. Administration at a dose level of 0.25 mg/kg bw, twice a week, for 5 months induced various degrees of liver changes in 24/24 animals characterized by biliary proliferation and focal appearance of the liver cells with multiple nuclei and giant-sized liver cells (EHC 11 (1979)). These effects were observed at dose levels within the guidance value range for Category 1. Additionally, there are following epidemiologic evidences; Aflatoxicosis (jaundice, fever, ascites, oedema of the feet and vomiting) occurred in India (106 people died out of a total of 397 patients) and in cases of an outbreak of jaundice accompanied by fatalities in Kenya, the livers showed centrilobular necrosis (both IARC 56 (1993)). Based on above information, the substance was classified into Category 1 (liver).	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）

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)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2009	GHS Classification Guidance by the Japanese Government （March, 2009）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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