MoCRA 2022 - Some "as-is unadulterated" references to support the contention that, as a
whole, pigments are not of concern toxicologically nor a danger to the public
in the application of tattooing. There is no evidence - zero evidence - that
pigments normally used are not dangerous as tattoo..
The Color Pigments Manufacturers Association Comments on EPA's HPV NPRM: A
Quoted from the published Letter to EPA OPPT Document Control Office Docket Number
"The CPMA has defined pigments as "Colored, black, white, or
fluorescent particulate organic or inorganic solids which usually are
insoluble in, and essentially physically and chemically unaffected by, the
vehicle or substrate in which they are incorporated. They alter appearance
by selective absorption and/or by scattering of light. Pigments are usually
dispersed in vehicles or substrates for application, as for instance in the
manufacture of inks, paints, plastics, or other polymeric materials.
Pigments retain a crystal or particulate structure throughout the coloration
"A critical characteristic of color pigments, therefore, is stability and
insolubility in the substrate which makes up the final use of the color
pigment. Indeed, this characteristic defines in large part the quality and
value of a color pigment in the marketplace. The more stable a color pigment
remains in harsh environments, including outdoor applications, the more
valuable that pigment will be in the marketplace. Such stability has
environmental benefit since stable coloring does not require re-coloring or
replacement of the colored product."
"With only a few recognized exceptions, color pigments, both organic and
inorganic, are extremely insoluble in water. As an example, copper
phthalocyanine organic pigments have a maximum solubility of less than a
part per trillion. A solubility in water could not be calculated for chrome
antimony titanate, an inorganic pigment, since the pigment cannot be
dissolved sufficiently in boiling sulfuric acid to create a calibration
curve. Color pigments are not, therefore, a threat to the environment when
disposed of with solid waste in appropriate lined landfills. Color pigments
are further protected from leaching into groundwater by the plastics, paints
and inks that make up the final products incorporating color pigments."
The single most important factor in evaluating the toxicological and
ecological properties of an organic pigment is its extreme insolubility in
water and in the application media.
“Pigments are therefore processed largely as solid, crystalline, and
therefore physiologically inert materials.
Since organic pigments are commonly combined with other materials, a
pigmented system typically contains only a small percentage of actual
pigment. It is, therefore likely that other components, such as binders,
solvents, and various agents may more severely affect the ecological and
toxicological properties of the applied product.”
p589, Industrial Organic Pigments, Production, Properties, Applications,
Third Completely Revised Edition, 2004, Willy Herbst, Krause Hunger ISBN
A comprehensive study, performed in the USA by DCMA* has show, that the
metal impurity in organic pigments is markedly below legal standardsDry
Color Manufacturers Association, now CPMA (Color Pigments Manufacturer’s
Toxicity of Organic Pigments
Organic pigments are extremely insoluble. As a result, these compounds are
non-toxic and very low in bioavailability. In the literature, there are
three published summaries concerning the acute toxicity of pigments.1
The vast majority of these LD50 values are above 5000 mg/kg and no LD50
values for pigments are known to be below 2000 mg/kg. As such, when compared
to other compounds, organic pigments are not, and should not, be assigned a
high regulatory priority based on toxicity. Since these compounds have been
found to be safe in extremely high doses, priorities and resources should be
directed toward compounds which raise concerns.
Therefore, due to their extremely low solubility, in both lipids and water,
organic pigments are not bioaccumulative nor do they bioconcentrate in the
food chain. This has been shown by extensive tests which have indicated
that, even though log P values for organic pigments may be calculated at
levels that would signal concern, in actual tests, organic pigments do not
exhibit any potential to bioaccumulate.
Synthetic colorants represent a relatively large group of chemicals met
practically everywhere in our daily life. Such potential hazardous chemicals
may have undesirable effects not only on the environment, but also on man.
To minimize the possible damage arising from production and applications of
such colorants, an international association called ETAD (Ecological and
Toxicological Association of Dystuff Manufacturing Industry) was founded in
1974, which coordinates the ecological and toxicological efforts of
organic-colorant manufacturers. …
… The following examples, are in part, based on investigations made by ETAD
groups some time ago. A survey of acute oral toxicities, as measured by the
so-called LD50 value demonstrated that of the 4,461 colorants tested, only
44 (ca. 1%) had a LD50 <250 mg/kg, but 3,669 exhibited practically no
toxicity (LD50>5g/kg). The evaluation of these colorants by chemical and
coloristic classification showed that the most-toxic compounds are found
among bisazo and cationic dyes. Pigments and vat dyes generally display very
low actual toxicities, presumably attributable to their generally poor
solubility in both hydro- and lipophilic media. Today, the LD50 test is
hardly performed anymore because of the large number of animals to be klilled.
Much more difficult to assess are chronic risks such as carcinogenicity and,
to a lesser extent, sensitization and allergies evoked by colorants. Since
long term tests with animals are difficult and ethically hard to justify,
carcinogenic risks are assessed by short-term bacteria/mammalian microsome
assays and by long-term observations of people working in dystuff
…Bisazo dyes based on benzidine are also known to be carcinogenic …
epidemiologic studies revealed an increased incidence of bladder cancer in
workmen exposed to benzidine.
…benzidine-type colorants are no longer produced by the large
dyestuff manufacturers. This policy also includes pigments. Benzidine
pigments are not really toxic, because it is very unlikely that these
insoluble materials are reduced in the intestinal tract. pp 583-6 Color
Chemistry, Heinrich Zollinger 2003
"...the most significant expansion
of the FDA's authority…since…1938:"
Westley W Wood, Pres.
Unimax Supply Co Inc.
NY NY 10013 (est. 1989)
Westley W Wood, Pres.
Unimax Supply Co Inc.
NY NY 10013