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EC number: 220-562-2
CAS number: 2814-77-9
In this study groups of 50 male and 50 female Wistar rats were
administered D&C Red No. 36 (Warner Jenkinson Company, NJ, USA; Purity >
95%) at dietary dose levels of 0, 1000, and 2000 ppm for 78 weeks
(estimated daily dose: 50 and 100 mg/kg b.w.). At week 98 all surviving
animals were killed and various organs were sampled and stored in
formalin. The organs sampled included at least lung, liver, spleen,
kidney, urinary bladder, mammary gland and thyroid gland. Survival of
rats was not affected by treatment. The number of survivors at
termination (week 98) was 50, 48 and 48 in males and 50, 47, and 50 in
females at 0, 1000, and 2000 ppm, respectively. The 7 animals which died
were excluded from evaluation since they died before week 40. Body
weight development was not affected in males but slightly, but
statistically significant lower in treated females when compared to the
control. Besides body weight data no information is available to assess
the systemic toxicity caused by PR4 and thus obtain an indication on the
bioavailability of the pigment.
Tumor incidences were reported for liver, thyroid, adrenals, urinary
bladder, and mammary gland (Table 4). The incidence of benign tumors was
low (£4%) in most tissues and not indicative of a
treatment-related effect. Higher tumor incidences were only observed in
the liver and mammary gland. The mammary tumor incidence in females and
of liver tumors in males was not indicative of an adverse effect. In
females the incidence of “liver tumors' was dose-dependently increased
(Please note: the incidences reported also include hyperplastic
nodules!). This increase was however not statistically significant. The
incidence of malignant tumors was likewise low and did not indicate a
relation to treatment.
Based on the data presented the authors conclusion was: “The results of
the present study thus demonstrated that D&C Red No. 36 at the
concentrations of 1,000 ppm and 2,000 ppm in the diet is not
carcinogenic either to male or female Wistar rats. While the occurrence
of benign liver tumors in female rats may be related to dye treatment,
the lack of any apparent dose-dependence or any statistically
significant difference from the control group (P = 0.06) suggests that
this is unlikely.”
A treatment-related increase of her tumors in females is questionable
since a) various types of her tumors and pre-neoplastic lesions were
lumped together and b) the historical background of liver tumors in the
strain of rats used in that laboratory is not known.
Furthermore, the unusual study design, 78 week testament followed by a
20 week treatment free 'recovery period', the exclusion of animals which
died pre-term as well as deficits in reporting make it impossible to
assess the validity of the study results.
A series of 14 cosmetic colors were submitted to dermal toxicity testing
in accordance with a protocol designed by the Food and Drug
Administration and agreed upon with the Cosmetic, Toiletry and Fragrance
Association (formerly the Toilet Goods Association). Dosage levels were
based on lipstick use determinations made in a group of human female
volunteers. The groups of lipstick colors were divided into three
treatment series and painted on twice weekly to an area approximately 6
cm2. A total of 1400 mice were used comprising groups of 100
mice (50 per sex) plus additional positive control group of the same
size and a vehicle control group of 300 mice (150 per sex). All colors
were prepared at 1.0% suspensions in water. The positive control
received 3.4–benzpyrene dissolved in acetone. Survival was approximately
equivalent in all experimental groups except the positive controls who
died earlier consistent with survival recorded by others for
3.4–benzpyrene treated mice. Extramedullary hematopoesis was found in
all treated groups, equivalent to the findings in the controls. The
repeated application of 0.1 ml containing 1.0% dye did not increase the
incidence of neoplasia when compared to controls in any of the groups
receiving application of the 14 dyes.
The International Agency for Research on Cancer evaluated Pigment Red 3
in 1992 and published the results in 1993. The data base for this
evaluation was the NTP study reviewed above. IARC concluded for Pigment
Red 3 that
• there is inadequate evidence in humans for the carcinogenicity of CI
Pigment Red 3, and
• there is limited evidence in experimental animals for the
carcinogenicity of CI Pigment Red 3.
Accordingly IARC grouped Pigment Red 3 in Group 3 as it ‘cannot be
classified as to its carcinogenicity to humans’.
Pigment Red 3 is one of the most widely used red pigments for
colouring of paints, inks, plastics, rubber and textiles. The pigment
was tested for carcinogenicity in rats and mice. In those species only
limited evidence for carcinogenicity was established. An overall
evaluation of the pigment, carried out by IARC, stated that it cannot be
classified as to its carcinogenicity to humans (IARC, 1993).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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