Explanation of table 1
Table 1 provides an alphabetical listing of about 4350 individual chemicals and other compounds (including 675 'new' chemicals, not mentioned in the previous edition) and approximately 2000 synonyms for which concentrations and vehicles for patch testing have been documented. The table has 6 vertical columns, which contain the following information:
1:Name of the chemical
2:Synonyms/other names
3:Patch test concentrations & vehicles, and reference numbers
4:Merck Index number
5:Cosmetic Ingredient Dictionary and Handbook monograph
6:Comments
Column 1: Name of the chemical
This column lists all chemicals, both "preferred names" and "synonyms/other names" alphabetically. To help in finding the chemical name, prefixes such as numbers, p-, m-, DL-, sym-, tert-, alpha-, etc. have been placed after the name itself. "Preferred names" begin with a capital letter. "Other names/synonyms" are not capitalized, unless they are trade names (recognizable by ©), abbreviations, official plant names or they begin with the name of a country, city, or a proper name.
The choice of the "preferred name" for a chemical has (with, for practical purposes, some exceptions) been standardized according to the following rules:
- fragrance materials investigated by the Research Institute for Fragrance Materials (RIFM) have their RIFM names as "preferred names". see http://www.rifm.org/ for more information
- chemicals (RIFM fragrance materials excepted) which are monographed in the Merck Index (14th Edition, 2006) have their Merck Index designation as "preferred name". See http://www.merck.com/ for more information
- chemicals which are neither mentioned in the RIFM monographs nor in the Merck Index, but which do have INCI names (International Nomenclature Cosmetic Ingredient) and consequently have a monograph in the CTFA Cosmetic Ingredient Dictionary and Handbook (11th Edition, 2006) have their Cosmetic Ingredient Dictionary name as "preferred name". See http://www.personalcarecouncil.org/ for more information on the International Nomenclature Cosmetic Ingredient and the CTFA Cosmetic Ingredient Dictionary and Handbook.
- colors which are neither mentioned in the Merck Index nor in the Cosmetic Ingredient Dictionary and Handbook have their "common name" or "color index name" (see ref 7) as "preferred name".
- for all other chemicals the "preferred name" is the name used in the publications where information was derived from.
New in this Edition is the application of the International Nomenclature Cosmetic Ingredient (INCI) for substances used in cosmetic products. These names are used for the mandatory ingredient labeling of cosmetics in the USA and the EU. Sources are the Cosmetic Ingredient Dictionary and Handbook (for USA, EU and Japan INCI data), and for the EU the websites http://ec.europa.eu/enterprise/cosmetics/html/cosm_inci_index.htm (legislation) and http://ec.europa.eu/enterprise/cosmetics/inci/inci_2006.pdf (alphabetical INCI list, the so-called "Inventory").
This (increasingly important) nomenclature system is not (yet) perfect for the following reasons:
- it is used in the USA, the EU, Japan and various other countries, but not in many other states
- many INCI names in the USA (especially colors and botanicals) are not part of the EU Inventory. Examples of such colors are 'red 21' and 'red 28'.In the EU these are named CI 45380 and 45410, but they are not mentioned as synonyms. 'Afromomum melegueta seed extract' and 'Agastache foeniculum powder' are monographed in the CTFA Dictionary and Handbook, but these names cannot be found in the EU Inventory.
- for botanicals, in both systems, the official Genus and species names are used. In the USA system, the common name of the plant is part of the INCI name (in brackets), e.g. Eugenia caryophyllus (clove), whereas in the EU system it is not.
- the USA system for any particular plant usually lists more botanical INCI names than are mentioned in the EU inventory. For Eugenia caryophyllus for example the EU INCI recognizes an extract, leaf oil and oil, whereas the INCI used in the USA lists flower extract, flower oil, flower powder, leaf extract and leaf oil.
- names in the EU and the USA for the same chemical can be different. CI 45380 for example, used in the EU as 'cosmetic colorant', may not be used for ingredient labeling in the USA, where the name 'red 21' must be used for certified, and 'acid red 87' for non-certified batches of the color. Other examples: 'egg' (USA) is termed 'ovum' in the EU, 'beeswax' 'cera alba', 'water' is 'aqua' and 'sea salt' is 'maris sal' in the EU. Ergo: a chemical can have 2 or even more INCI names (CI 42090 = blue 1 = acid blue 9)
- sometimes in the EU for colorants different names must be used depending of the cosmetic product of which it is part. Thus, the name CI 45380 must be used for labeling all cosmetic products except for hair dyeing products, for which the name 'acid red 87' is indicated
- an INCI name may cover several chemical entities. For example: CI 15630 refers not only to pigment red 49, but also to its aluminium lake, barium lake, calcium lake and strontium lake
In spite of this, the INCI is a very valuable nomenclature that has well proven its value and will continue to become more important, useful and efficient as nomenclature differences and regulations between countries decrease or disappear (harmonization).
The distinction between RIFM, Merck Index and INCI names
It can easily be established in Table 1 whether the names mentioned are RIFM, INCI or Merck Index (MI) names:
- when the test concentration or one of the test concentrations mentioned in column 3 is followed by reference numbers 4,11,12 or 14 in brackets, the name in column 1 (the preferred name) is always the RIFM name. If there are synonyms with a Merck Index name or an INCI name, these synonyms are followed by (MI) or (INCI). If there are no synonyms, but there is a number in column 4 (indicating that there is a Merck Index Monograph), this means that the RIFM name is also the Merck Index name. If there are no synonyms but there is a "+" in column 5 (indicating that there is an INCI Monograph), this means that the RIFM name is also the INCI name
- when in column 4 a Merck Index number is mentioned, the preferred name (the entry) is the Merck Index name. If there are synonyms with an INCI name, these synonyms are followed by (INCI). If there are no synonyms but there is a "+" in column 5 (indicating that there is an INCI Monograph), this means that the Merck Index name is also the INCI name.
- when there is a "+" in column 5, no MI number and no references 4,11,12 or 14 in column 3, the preferred name is the INCI name.
Column 2: Synonyms/other names
This column may list one or more synonyms when the corresponding chemical in column 1 is a "preferred name", or refers to the "preferred name" when the corresponding chemical in Column 1 is a synonym ('see ....').
Column 3: Patch test concentrations & vehicles, and reference numbers
This column provides for each chemical ("preferred name") in Column 1 concentrations and vehicles for patch testing as recommended by various authors (references in brackets). As for the major textbooks, the concentrations and vehicles derived from references 1,2,6,8,9,10,22 and 23 are recommended as such by the authors of these books. The concentrations and vehicles derived from references 5 and 18 sometimes, and from reference 7 usually refer to other (original) publications, and consequently are not (always) implicitly recommended as such for patch testing by the authors of these books. The concentrations and vehicles derived from references 4, 11,12 and 14 are not recommended test concentrations, but such that did not cause irritation after a 48 hour closed patch test in a panel of 20 volunteers. The other references are original publications in "Contact Dermatitis", "The American Journal of Contact Dermatitis" and "Dermatitis" and the test concentrations and vehicles from these sources were the ones used (and usually recommended) by their authors.
The abbreviations used for the vehicles are as follows:
| acet | = | acetone |
| alc | = | alcohol |
| bl | = | butyrolactone |
| chlorof | = | chloroform |
| co | = | castor oil |
| comm prep | = | commercial preparation |
| dep | = | diethyl phthalate |
| DMSO | = | dimethyl sulfoxide |
| epi | = | 45% alcohol, 10% propylene glycol, 45% isopropyl alcohol |
| ethyl acet | = | ethyl acetate |
| euc anh | = | eucerinum anhydricum |
| glyc | = | glycerol |
| isopr alc | = | isopropyl alcohol |
| isopr palm | = | isopropyl palmitate |
| MEK | = | methyl ethyl ketone |
| mo | = | mineral oil |
| ol arach | = | oleum arachidis |
| oo | = | olive oil |
| paraff liq | = | paraffinum liquidum |
| peg | = | polyethylene glycol |
| pet | = | petrolatum |
| prop glyc | = | propylene glycol |
| sat sol | = | saturated solution |
| sol | = | solution |
Column 4: Merck Index number
A number in this column means that the corresponding chemical in Column 1 is monographed in the Merck Index (14th Edition, 2006), the number corresponding to the chemical's Merck Index monograph number.
Column 5: Cosmetic Ingredient Dictionary and Handbook Monograph
A "+" in this column means that the corresponding chemical in Column 1 is monographed in the CTFA Cosmetic Ingredient Dictionary and Handbook (11th Edition, 2006).
Column 6: Comments
This column contains a variety of information, all of which relates more or less directly to patch testing procedures (e.g. "test concentration may be irritant", "20 controls were negative", "no controls mentioned", "risk of patch test sensitization" etc.), When a chemical has caused photosensitivity, immediate contact reactions (contact urticaria) or patch test sensitization, relevant information and references are given under this heading.
A complete list of chemicals which have caused photosensitivity is provided in Table 5, of chemicals which have caused immediate contact reactions (contact urticaria) is provided in Table 6, and of chemicals which have caused, or are at risk of causing, patch test sensitization is provided in Table 7.
Sometimes in this column it may read: "see note A" or "see note B". These notes have the following meaning:
Note A References 4, 11, 12 and 14 relate to fragrance materials tested by the Research Institute for Fragrance Materials (RIFM). The irritant properties of each fragrance material have been evaluated by a 48-hour closed patch test on a panel of human subjects. Thus, the concentration and vehicle (which is almost always petrolatum) mentioned in column 3 is not a test advice from RIFM, but a test concentration which did not induce irritation after a 48-hour closed patch test . This concentration may consequently be (reasonably) safe for patch testing, as far as irritation is concerned.
Note B Cosmetic ingredients In a (meanwhile terminated) study, the members of the Dutch Contact Dermatitis Group and several non-member dermatologists interested and experienced in contact dermatitis have tested patients suspected of allergic cosmetic dermatitis with all ingredients of cosmetic products reacting upon patch testing. The ingredients were prepared for patch testing by the Cosmetics Division of the Food Inspection Service, PO Box 777, 7500 AT Enschede, the Netherlands (former Head: J. Willem Weyland, Ph.D.). The test concentrations and vehicles for ingredients for which there are no published patch testing data were advised by Dr. Weyland and the author, based on their experience and the chemical nature of the ingredients ("educated guess"). Test concentrations mentioned in column 3 and referring to reference 76 have been patch tested in 1-20 patients suffering from or suspected to suffer from contact allergy to cosmetic products. No irritant reactions were observed. These test concentrations and vehicles consequently should not be regarded as our "test advice", but rather should give the investigator some direction in deciding what concentration/vehicle to choose for this particular chemical.
Test advice The column "Comments" also provides for a (relatively small) number of chemicals advice for test concentration and vehicle. Such test advice (on the basis of assessment of literature data) is, with a few exceptions, given only then when Column 3 "Patch test concentrations & vehicles and reference numbers" has two or more test recommendations, which differ considerably, either in concentration or in the nature of the vehicle for testing. We have not always given test advice where more recommendations were provided, because there is usually little sound evidence for what would be the "right" concentration and vehicle. As many of these recommendations were made by experienced and authoritative investigators, it would be somewhat presumptuous to select one, except when data from the literature or personal experience would support such a choice. However, in the vast majority of cases, the reader will find no difficulty in choosing a concentration and vehicle for patch testing, on the basis of the data provided in this book.
Commercially available allergens. These are indicated by "Trolab", "Chemo", and "Brial".
Trolab
Allergens available from Trolab
Almirall Hermal GmbH
Scholtzstrasse 3
21465 Reinbek Germany
Phone: +4940727040, Telefax +49407229296.
Email: info@Hermal.de, website: http://www.hermal.com/
Chemo
Allergens available from
Chemotechnique Diagnostics
Modemgatan 9
S-235 39 Vellinge
Sweden
Phone: +4640466077, Telefax:+4640466700
Email: info@chemotechnique.se, website http://www.chemotechnique.se/
Brial
Allergens available from
Brial allergen GmbH
Bövemannstrasse 8
48268 Greven
Germany
Phone: +49257193970, Telefax +492571939720
Email: info@brial.com, website http://www.brial.com/
If only one concentration and vehicle is mentioned in column 3 and the commercial allergens have the same concentration and vehicle, only the company providing the allergens are mentioned, e.g. 'Trolab, Brial'. In all other situations, the test concentrations and vehicles of the commercial allergens are specified after the company name, e.g. 'Chemo (0.1% aqua)'


