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Directorate-General for Health and Food Safety
Summary sheet on Commission
Review (ref. XXIV/1991/97)
Ingredient : Aristolochic acid (I,II,V)
CAS n° : 313-67-7; 475-80-9; 15918-62-4; 61117-05-3
Function and max in use concentration : botanical
Relevant toxicity data :
Assessment of acute toxicity (oral, i.v.) : Toxic for kidneys.
Assessment of chronic/sub-chronic toxicity : Repeated dose toxicity (oral 21 d., 90 d.): multiple carcinogenic gastrointestinal tract cell metaplasia.
Assessment of genotoxicity/carcinogenicity: Mutagenic in vitro, clastogenic in vitro and in vivo. Very potent carcinogen affecting forestomach, kidneys and several other organs.
Human data: Causal factor in "Chinese herb nephropathy" (kidney destructive process).
Classification: 2a (See Classification of Substances)
SCCNFP Opinion
Aristolochic acid (A.A.) is mutagenic in bacteria, in mammalian cells and in Drosophila.
A.A. binds covalently to DNA inducing similar DNA adducts in vitro and in vivo in rats.
A.A. is a very potent carcinogen affecting the forestomach and several other organs including the kidneys in mice and rats after short induction periods with low doses. In rats, the effects were shown to be time and dose dependent.
Very recently (1996) A.A. derived DNA adducts biomarkers of A.A. exposure, were found in renal tissues of patients suffering from a rapid kidney destructive fibrotic process designated as Chinese Herbal Nephropathy.
These data support SCCNFP opinion that Aristolochic acid and salts must not be used in cosmetic products. Moreover, A.A. being the active constituent of Aristolochia species, the SCC is of the opinion to extend that the ban to Aristolochia species and preparations.
Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
Ingredient : Aristolochic acid (I,II,V)
CAS n° : 313-67-7; 475-80-9; 15918-62-4; 61117-05-3
Function and max in use concentration : botanical
Relevant toxicity data :
Assessment of acute toxicity (oral, i.v.) : Toxic for kidneys.
Assessment of chronic/sub-chronic toxicity : Repeated dose toxicity (oral 21 d., 90 d.): multiple carcinogenic gastrointestinal tract cell metaplasia.
Assessment of genotoxicity/carcinogenicity: Mutagenic in vitro, clastogenic in vitro and in vivo. Very potent carcinogen affecting forestomach, kidneys and several other organs.
Human data: Causal factor in "Chinese herb nephropathy" (kidney destructive process).
Classification: 2a (See Classification of Substances)
SCCNFP Opinion
Aristolochic acid (A.A.) is mutagenic in bacteria, in mammalian cells and in Drosophila.
A.A. binds covalently to DNA inducing similar DNA adducts in vitro and in vivo in rats.
A.A. is a very potent carcinogen affecting the forestomach and several other organs including the kidneys in mice and rats after short induction periods with low doses. In rats, the effects were shown to be time and dose dependent.
Very recently (1996) A.A. derived DNA adducts biomarkers of A.A. exposure, were found in renal tissues of patients suffering from a rapid kidney destructive fibrotic process designated as Chinese Herbal Nephropathy.
These data support SCCNFP opinion that Aristolochic acid and salts must not be used in cosmetic products. Moreover, A.A. being the active constituent of Aristolochia species, the SCC is of the opinion to extend that the ban to Aristolochia species and preparations.
Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
