Coumarin
(in 3,574 products)

Potential Risk Index®:

ISCE InhaleISCE SwallowISCE ContactISCE Environment
PRI Legend

About:

Functions:
1. Drug / Medicine - Used to treat, alleviate, cure or prevent sickness. As officially declared by a governmental drug/medicine regulatory body
2. Flavor / Flavoring / Flavor Enhancer - Provides or enhances a particular taste or smell.
3. Fragrance / Fragrance Component - Provides or enhances a particular smell or odor.
Coumarin is a fragrance ingredient with a sweet aroma that can be found in many plants such as blackberries, strawberries and cherries. It is also the primary drug precursor used to make warfarin, an anticoagulant (prevents the blood from clotting). [1]
Recent Findings:
Many studies conducted by the European Union Scientific Committee on Consumer Safety (EU SCCS) have shown that coumarin is unlikely to induce delayed contact hypersensitivity. [2] [3] [4] In cases where there is a positive response for being a skin sensitizer, "the reproducibility of test results between experiments was however low." [4]
In a separate study to determine the ingredient which causes an allergic reaction in a 44-year-old woman showed coumarin and ethyl vanillin to be responsible. [5] However this is merely a one-off event where in combination with the other ingredients of the fragrance mix, resulted in a negative patch test result. Only at concentrations of ~2% could coumarin be able to elicit allergic contact reactions.
There's limited evidence of coumarin being a skin sensitizer. However, there are some coumarin derivatives which may be more skin sensitizing than others. "Dihydrocoumarin and daphnetin were found to be moderate to strong sensitizers" while fraxetin and 7-methyl coumarin were "completely inactive". [6] Approximately the same results can be found in a similar study conducted on guinea pigs. [7] A study on coumarin conducted on 14,000 individuals showed a 0.41% chance for overall coumarin sensitivity and 0.14% chance of coumarin alone. [8] The same study also concluded that coumarin is safe to use in concentrations of up to 5-8%. [8]
Photosensitization tests showed that "topically applied coumarin was not a primary photosensitizer" [8] and that it "[does] not evoke phototoxic reactions". [9]
Due to the hydrophilic and hydrophobic character of coumarin, it is able to rapidly penetrate through the skin of rats and humans (at >75% and >95% respectively). [10] It is feared that this may lead to hepatotoxicity which has already been observed in rats. [10] However, separate studies have shown that this is due to the species differences in how coumarin is metabolized within the body. Therefore "species differences in coumarin hepatotoxicity appear to be metabolism-mediated" and that "liver toxicity in patients receiving relatively high daily doses of coumarin is very rare". [11] Animal toxicity tests on coumarin conducted on dogs and gibbons showed far less toxicity with no evidence of teratogenicity or mutagenicity. [12]
EU CosIng Annex III Restriction Information:
Regulation:
(EC) No 1223/2009
Regulated By:
2003/15/EC
Annex/Ref#:
III/77
Other:
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)g when its concentration exceeds:
- 0.001% in leave-on products
- 0.01% in rinse-off products
SCCS opinions:
0450/01 - Memorandum on the SCCNFP Opinion concerning Fragrance Allergy
0673/03 - Opinion concerning Essential Oils
0935/05 - Opinion on Coumarin (sensitisation only)
0017/98 - Opinion concerning Fragrance Allergy in Consumers - A Review of the Problem -
Analysis of the need for appropriate Consumer Information and Identification of Consumer Allergens
0202/99 - Opinion concerning the Interim Position on Fragrance Allergy
Scientific References:
2. The skin allergenic properties of chemicals may depend on contaminants. Evidence from studies on coumarin. 2006 which journal? (from EU SCCS)
3. CIT/Study No. 21214 TSS/Rhodiascent TM Coumarine/Rhodia Services –RSP 13 December 2001 (from EU SCCS)
4. INSERM U503/Société Rhodia Services. Evaluation du potential de sensibilisation cutanée des Coumarines à l’aide du Local Lymph Node Assay murin. 10 décembre 2003 (from EU SCCS)
5. Identification of coumarin as the sensitizer in a patient sensitive to her own perfume but negative to the fragrance mix. (Contact Derm., 40(4), 196–199. doi:10.1111/j.1600-0536.1999.tb06033.x)
6. The sensitizing capacity of coumarins (II). (Contact Derm., 15(5), 289–294. doi:10.1111/j.1600-0536.1986.tb01370.x)
7. Sensitization and Crossreaction of Simple Coumarins. (YAKUGAKU ZASSHI, 121(1), 97–103. doi:10.1248/yakushi.121.97)
8. The rôle of coumarin in patch testing. (Contact Derm., 39(6), 327-328.)
9. Photosensitization by coumarin derivatives (Arch. Dermatol. 1981 May;117(5):258-63.)
10. Percutaneous Absorption and Metabolism of Coumarin in Human and Rat Skin. (J. Appl. Toxicol., 17(3), 153–158. doi:10.1002/(sici)1099-1263(199705)17:3<153::aid-jat426>3.0.co;2-e)
11. Species differences in the metabolism and hepatotoxicity of coumarin. (Comp. Biochem. Physiol. C, Pharmacol. Toxicol. Endocrinol., 104(1), 1–8. doi:10.1016/0742-8413(93)90102-q)
12. Critical review of the toxicology of coumarin with special reference to interspecies differences in metabolism and hepatotoxic response and their significance to man. (Food Cosmet. Toxicol., 17(3), 277–289. doi:10.1016/0015-6264(79)90289-x)
Regulatory References:
1. EU CosIng Annex III, SUBSTANCES WITH RESTRICTIONS IN COSMETIC PRODUCTS [2018]
- Ref: III/77

Safety and Hazards (UN GHS):

1. Harmful if swallowed (H302)
2. May cause an allergic skin reaction (H317)
3. Causes damage to organs through prolonged or repeated exposure (H373)
4. Harmful to aquatic life (H402)

Potential Health Concerns For:

1. Bile Duct Diseases (PubMed ID:28803882)
2. Chemical and Drug Induced Liver Injury (PubMed ID:26946349)
3. Hepatomegaly (PubMed ID:28108177)
4. Liver Neoplasms (PubMed ID:28108177)
5. Necrosis (PubMed ID:1284839)
6. Skin Diseases (PubMed ID:1874656)
7. Thrombosis (PubMed ID:1874656)

Potential Health Benefits For:

1. Diabetes Mellitus, Type 2 (PubMed ID:19647726)
2. Kidney Diseases (PubMed ID:21630391)
3. Venous Insufficiency (PubMed ID:12708602)

User Comments:

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