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EC number: 231-494-8 | CAS number: 7585-41-3
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Pigment Red 48:1(Ba) is not genotoxic in vitro based on experimental data with Pigment Red 48:1(Ba) and pigments of the same category.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see the category read-across justification in the category object.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- other: clastogenicity negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- other: polyploidy positive at precipitation
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see the category read-across justification in the category object.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- no independent repeat experiment. No allowance for azo-reduction.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no independent repeat experiment
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Chemical name: 2-Naphthalenecarboxylic acid, 4-[5-chloro-4-methyl-2-sulfophenyl)azo]-3. hydroxy-, barium salt (1:1)
- Identity: SYMULER NEOTHOL RED 2BY
- Appearance: Red powder
- Storage conditions: Room temperature in the dark
- Lot number: 92688
- Expiry date: January 2003
- Date received: 11 January 2002
- Purity/Assay: >98% - Target gene:
- histidine operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 µg/plate
- Vehicle / solvent:
- water containing 0.15% agar
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-Aminoanthracene and 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Pre-incubation method, duplicate plates per dose and strain
OTHER: no independent repeat experiment - Evaluation criteria:
- Increase in mutant frequency compared to solvent control; comparison with historical controls
- Statistics:
- not required
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro mutagenicity in bacteria
Pigment Red 48:1(Ba) was found to be non-mutagenic in bacteria (DIC 2002). This study was performed following OECD testing guideline 471. No allowance was made for reductive metabolism of the azo function and no independent repeat experiment was included. The test item showed strong precipitation which is in line with the overall very low solubility.
No other data on Pigment Red 48:1(Ba) was available. Detailed experimental data is available for the analogue calcium salt Pigment Red 48:2(Ca), which is also poorly soluble, but of slightly better solubility than Pigment Red 48:1(Ba). Considering the better solubility and the absence of carcinogenic properties of soluble Barium chloride, data on Pigment Red 48:2(Ca) is adequate for read-across.
The mutagenicity of Pigment Red 48:2(Ca) in vitro was assessed in two tests applying both the standard assay with rat liver homogenate and the modified assay for azo compounds (Prival-assay). Tested samples were commercial products containing varying amounts of additives. With the limitation in the number of tester strains, the non-key study is reliable and valid in regard to design, positive and negative control and concentrations. The key study was performed following the latest OECD testing guideline (OECD 471, adopted July 12, 1997) and the principles of GLP and included the Prival assay modification to take into account reductive metabolism of the azo bond.
In vitro mutagenicity in mammalian cells
Mutagenicity in mammalian cells in vitro was investigated of Pigment Red 48:2(Ca) in a HPRT test following OECD testing guideline 476 (adopted July 21, 1997) and the principles of GLP. The test was performed with a sample synthesized without additives and a purity of 99.4%. No indication of a mutagenic effect was observed at concentrations up to 720mg/plate, at least the two highest concentrations being in the precipitating range. This is consistent with the absence of unscheduled DNA synthesis as tested with both with human fibroblasts (Puri 1985) and with primary hepatocytes prepared from arochlor1254-induced rats (Puri 1985). The latter studies were performed under GLP and in combination fulfil the requirements of OECD testing guideline 482 (adopted October 23, 1986). For the DNA-repair assays, concentrations were in similar range and also resulted in precipitation. Higher concentrations were too toxic for scoring. For these two studies, commercial samples with adequately high pigment content were tested.
In vitro clastogenicity in mammalian cells
Clastogenicity of Pigment Red 48:2(Ca) in mammalian cells was investigated in a guideline (OECD 473. adopted July 21, 1997) and GLP compliant study (Höpker 2007). The test was performed with a sample synthesized without additives and a purity of 99.4%. The highest evaluable concentrations were chosen based on visual observation of precipitates. No indication of clastogenicity or polyploidy were observed in either study.Justification for classification or non-classification
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 genetic toxicity according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.
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