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EC number: 241-806-4 | CAS number: 17852-98-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
Feeding studies on carcinogenic properties in rats and mice are available for the sodium salt of Pigment Red 57:1 (CTFA 1981a and b). Drinking water studies on carcinogenic properties in rats and mice are available Barium chloride (US NTP 1994). All studies are comparable to OECD testing guideline 451 and 453. No indication of carcinogenic properties was observed after life-long feeding of 0, 0.05, 1 and 5 % in the diet to mice and after 0.05, 0.3 and 2.0 % in the diet to rats. No indication of carcinogic properties were observed upon drinking water application at 2500 ppm. No indication of carcinogenic properties was observed in a skin painting study in mice with 50 mg/kg bw of Pigment Red 57:1 (Carson 1984). The substance is therefore considered to be non carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
Classification, Labelling, 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 carcinogenicity under Regulation (EC) No. 1272/2008.
Additional information
Adequate and reliable data on carcinogenicity is available for both Ba2+and the structural analogue of the organic anion.
The available experimental data on the sodium salt of the organic anion (Pigment Red 57) is adequate in design in reporting to allow hazard assessment of the organic part of the pigment. Pigment Red 57:1 differs by the absence of a chlorine substituent at the sulfonated phenyl ring.
The study in rat was designed to meet US FDA requirements for long-term feeding studies, it combines a fertility element, in-utero-exposure and long-term exposure of the offspring (CTFA 1981). All parameters required for OECD testing guideline 453 are addressed. The design of the study in mice meets all requirements of OECD testing guideline 451 (CTFA 1981). The purity of the test substance was reported to be 95% and stability in the feed was verified analytically. The studies were initiated prior to the introduction of Good Laboratory Practice in 1981. During the course of the study, GLP was introduced and so the last part was performed under GLP.
The sodium salt is of better water solubility that the divalent BONA metal laked salts and may be absorbed to a lesser extent. In the chronic feeding studies systemic availability of the sodium salt was confirmed by a dose-dependent colouration of urine. Considering the high doses applied in the feed, the studies with the sodium salt are adequate for hazard assessment of the organic anion of Pigment Red 57:1.
No indication of genotoxicity of Pigment Red 57:1 was observed in in-vitro studies.
No indication of carcinogenic properties was observed in a skin painting study in mice with Pigment Red 57:1 (1984). The investigation was performed prior to introduction of GLP. Limited details are given in the literature publication. The study was designed by thecompetent authority and an industry association to assess the safety of the use in lipstick. For 18 months, mice were given 0.1 ml of an aqueous solution of 1% onto an area of 6 cm2twice per week. This corresponds to a dose of 1 mg per mouse (50 mg/kg bw) per treatment. Full histopathology was only performed for 5 of 50 animals per dose group.
No carcinogenicity hazard of Barium is derived from two GLP-compliant chronic drinking water studies with Barium chloride dihydrate (CAS10326-27-9 ) in rats and mice at concentrations of 500, 1250 or 2500 ppm (US NTP 1994). For both species, doses were chosen based on reduction in drinking water consumption and toxicity observed after drinking water application at 4000 ppm for 13 weeks. 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. Stability of the application solution was verified analytically. Exposure was 104 weeks or longer. For mice, but not for rats, a reduction in survival rate was recorded for the highest dose group. Reduction in survival of mice was linked to renal toxicity.
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