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EC number: 267-122-6
CAS number: 67801-01-8
Studies on carcinogenicity of the test item were not performed. Since both substances are Ba-salts with comparable structur and similar solubility, information on the carcinogenic potential were derived from experimental data of a structural analogue. In a longterm 2-year feeding study with Osborne-Mendel rats there was no increase in tumour incidence up to the highest feeding level. ICR mice with demal exposure for 18 months showed no increased evidence of neoplasms. In the course of a NTP bioassay conducted with rats and mice, no findings were seen in mice or female rats. Fibrosarcomas in spleen were found in high dose male rats. With regard to the absence of genotoxicity and cytotoxicity and the presence of hematotoxicity, fibrosarcoma formation in spleen in cosidered to be a secondary effect due to methemoglobin formation and excessive erythrocyte damaging. No indication of carcinogenic properties was observed upon drinking water application at 2500 ppm.
food (mean) and compound intake
Dangerous Substance Directive
The available studies are considered
reliable and suitable for classification purposes under 67/548/EEC. As
a result the substance is not considered to be classified for
carcinogenicity under Directive 67/548/EEC, as amended for the 28th time
in Directive 2001/59/EC.
Classification, Labeling, and
Packaging Regulation (EC) No. 1272/2008
The available experimental test data
are reliable and suitable for classification purposes under Regulation
1272/2008. As a result the substance is not considered to be classified
for genotoxicity under Regulation (EC) No. 1272/2008, as amended for the
second time in Directive (EC 286/2011).
Carcinogenicity of the
test substance was not examined. The test item shares high structural
similarity to an analogue substance, since both are Ba-salts which
differ in additional ethyl-group only. Both substances are poor soluble
in water and octanol and dissolve most likely in an acidic environment
(e.g. stomach). Therefore, it is acceptable to derive information on the
carcinogenic potential from experimental data of the analogue substance.
100 ICR mice received pigment red 53:1 two times per week
for 18 months at the shaven back (Carson et al 1974). Dosage levels were
based on lipstick use determinations made in a group of human female
volunteers. Twice each week a 0.1 ml dose containing 1 mg of the dye was
applied to the dorsal skin of each mouse. All animals were necropsied;
after termination of the study, tissues were selected for
histopathology, sectioned, stained and examined by a pathologist. The
repeated application of 0.1 ml containing 1 % dye did not increase the
incidence of neoplasms when compared to the vehicle controls.
Groups of 50 B6C3F1 mice received diets containing 1,000
or 2,000 ppm of test substance for 103 weeks (NTP 1982). After week 50,
the mean body weight of high-dose female mice was lower than that of the
controls. No compound-related effect on survival or clinical signs were
observed for mice of either sex. Under the conditions of this bioassay,
D & C Red No. 9 was not carcinogenic for B6C3F1 mice of either sex.
Fisher 344 rats received 0, 1000 or 3000 ppm pigment red
53:1/kg bw for 103 weeks with the daily feed (NTP 1982). In males and
females of the 3000 mg group non-neoplastic damage to the spleen (focal
and diffuse fibrosis, lesions and splenic capsule) occured. There were no
splenic sarcomas in low dose males or any of the female groups. There
were small increases in neoplastic nodules of the liver in male rats.
Osborne-Mendel rats received 0,
0.01, 0.05, 0.25 and 1% pigment red 53:1 of the daily feed for two years
(David and Fitzhugh 1962). Growth and mortality was unaffected. In the
two highest dosage groups depressed haemoglobin levels, abnormal shape
of erythrocytes and slight hyperplasia of bone marrow occurred. In the
highest dosage group moderately to strong splenomegaly as well as
haemosiderosis and partial infarction of the spleen was seen. Compared
to the untreated control animals there was no increase in tumour
a chronic drinking water study Barium chloride dihydrate
was administrated for 104 weeks to rats
and mice at concentrations of 500, 1250 or 2500 ppm (NTP 1994). Based on
drinking water consumption, the average uptake of the highest dose was
60 and 75 mg/kg bw for males and female rats, respectively and 160 and
200 mg/kg bw for male and female mice, respectively. Systemic
availability of Barium was confirmed by monitoring of serum
concentrations. For mice, a reduction in survival rate was recorded for
the highest dose group, most likely due to renal toxicity. There was no
increased evidence for tumor formation in rats or mice.
The substance was tested for its carcinogenic potential
in several studies. In one study with rats, high dose male animals
developed splenic sarcomas and neoplastic nodules of the liver. Whereas,
female animals and mice had no tumors. The neoplastic nodules in male
high dose rats were not malignant and represent an early stage in the
development of liver tumors in rats. It is not clear that any of them
would have progressed to hepatocellular carinomas even if the rats had
been allowed to live longer. Oral or dermal application of the test item
to mice for 2 years gave no hints for a carcinogenic potential. Also
oral administration to Osborne-Mendel rats for 2 years did not result in
tumor formation. However, splenomegaly, hemosiderosis and splenic
infarcts were seen at the high dose group.
Taken together, the substance has no genotoxic potential
and does not interact with DNA or genetic material. Most likely,
metabolites of the test article (1-amino-2-naphtol) cause
methemoglobinamia leading to disturbances of iron metabolism and
subsequently increased iron deposition in liver and spleen
(hemosiderosis). Moreover, the substance or metabolites are attached at
methemoglobin and transported via red blood cells into the spleen which
acts as a filter for old or damaged erythrocytes. During degradation of
methemoglobin, the substance or metabolite is released and affects
spleenic mesenchymal tissue leading to fibrosis and promotion of tumor
formation (sarcomas). Finally, the substance acts as a secondary
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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