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About the Carcinogenicity of the Product
Posted Date:2022/11/25
GHS definition and determination of mixtures:
Carcinogens are substances or mixtures that can cause cancer or increase the incidence of cancer. Substances and mixtures that induce benign and malignant tumors in properly performed experimental animal studies are also considered putative or suspected human carcinogens unless there is conclusive evidence that the tumorigenesis mechanism is unrelated to humans.
The classification of a substance or mixture as a carcinogenic risk is based on its nature and does not provide information about the level of carcinogenic risk to humans that may result from the use of the substance or mixture.
Determination of carcinogenicity of mixtures
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Composition is divided into
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The critical value/concentration limit that causes classification of a mixture
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Class 1 carcinogen
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Class 2 carcinogen
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1A
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1B
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Class 1A carcinogen
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≥0.1%
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--
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--
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Class 1B carcinogen
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--
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≥0.1 %
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--
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Class 2 carcinogen
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--
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--
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≥0.1%(Note 1)
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≥1.0%(Note 2)
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Note 1: IF THE concentration OF a CLASS 2 carcinogen ingredient in the mixture is between 0.1% and 1%, then each competent authority will require information on the safety data sheet of the product. However, label warnings are optional. Some authorities opt for labelling when the concentration of the ingredient in the mixture is between 0.1% and 1%, while others do not normally require labelling in such cases.
Note 2: If the concentration of a Class 2 carcinogen ingredient in the mixture is > 1%, then both a safety data sheet and a label are generally required.
Carcinogenicity determination
In accordance with the principles of the GHS Guidance Instrument: criteria developed for the classification of mixtures will allow the use of existing data on the mixture itself, and/or similar mixtures, or on the composition of mixtures. The classification data of the International Agency for Research on Cancer are generally used as a reference. IARC (International Agency for Research on Cancer), the International Agency for Research on Cancer (IARC), has organized expert groups since 1971 to collect and evaluate the information about the carcinogenic risk of chemical substances to human beings in various countries.
Category 1: Carcinogenic
Group 1, which is carcinogenic to humans. Those with sufficient evidence of carcinogenicity in humans belong to this group. Such as smoking and secondhand smoke.
Category two: probably carcinogenic
Group 2, which is a probable or probable carcinogen in humans. They were further divided into two groups, namely group 2A and group 2B.
Group 2A, probably carcinogenic to humans, referring to probably limited evidence of carcinogenicity in humans. There is sufficient evidence of carcinogenicity in experimental animals. Such as the production of art glass, commonly used hair dryer barber.
Category 3: Possibly carcinogenic
Group 2B, possible carcinogens for humans, refers to limited evidence of carcinogenicity in humans and insufficient evidence of carcinogenicity in experimental animals; Or refers to insufficient evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals.
Category 4: Unknown
Group 3, the available evidence does not allow classification of human carcinogenicity.
Category 5: Probably not carcinogenic
Group 4, which may be non-carcinogenic to humans.