GHS Classification Result

Chemical Name:Aflatoxins
CAS:1402-68-2

Result:
ID: 21A3620
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid (room temperature)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (room temperature)
5 Gases under pressure Not applicable - - - - Solid (room temperature)
6 Flammable liquids Not applicable - - - - Solid (room temperature)
7 Flammable solids 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 (room temperature)
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 (room temperature)
14 Oxidizing solids Not applicable - - - - The substance contains 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
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 2 Danger H300: Fatal if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Solid (room temperature)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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)).
6 Carcinogenicity Category 1A Danger H350: May cause cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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)).
7 Reproductive toxicity Category 1B Danger H360: May damage fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
8 Specific target organ toxicity - Single exposure Category 1 (liver) Danger H370: Causes damage to organs (liver) P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
9 Specific target organ toxicity - Repeated exposure Category 1 (liver) Danger H372: Cause damage to organs through prolonged or repeated exposure (liver) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
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).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - No data available.


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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