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EC number: 257-776-0 | CAS number: 52238-92-3
- 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 242 (nano form): Negative (Ames, CA)
Analogue substance: Pigment Red 166 (not specified form): Negative (Ames, OECD 476, OECD 474)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Analogue substance Pigment Red 166 (not specified form): Negative (MN)
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (purity not reported)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- (1997)
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
- Species:
- hamster, Chinese
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 23-30 g, female: 21-29 g
- Housing: single cage (individually)
- Diet (e.g. ad libitum): NAFAG No. 924
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24°C
- Humidity (%): 46 - 70%
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: PEG 400
- Concentration of test material in vehicle: 62.5 , 125, 250 mg/mL
- Amount of vehicle (if gavage or dermal): 20 mL/kg - Details on exposure:
- after 48 hrs of first application animals were sacrificed
- Duration of treatment / exposure:
- 48 hrs
- Frequency of treatment:
- 2 doses per animal; once daily
- Post exposure period:
- 24 hrs
- Remarks:
- Doses / Concentrations:
1250 mg/kg bw
Basis: - Remarks:
- Doses / Concentrations:
2500 mg/kg bw
Basis: - Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis: - No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide:
- Route of administration: oral
- Doses / concentrations: 128 mg/kg in 20 mL/kg PEG 400 - Tissues and cell types examined:
- Blood cells of bone marrow
- Details of tissue and slide preparation:
- Bone marrow was harvested from the shafts of both femurs. In a siliconized pipette filled with approx. 0.5 μL rat serum the bone marrow was drawn up. Small drops of the mixture were transferred on the end of a slide, and the preparations were air-dried. After 3 hrs, the slides were stained in undiluted May-Gruenwald solution for 2 min then in May-Gruenwald solution/water 1/1 for 2 min and then in Giemsa's, 40% for 20 min. After being rinsed in methanol 55% for 5-8 s and washed off twice in water, they were left immersed in water for approx. 2 min. After rinsing with distilled water and air-drying, the slides were cleared in Xylol and mounted in Eukitt.
- Evaluation criteria:
- 1000 bone marrow cells each were scored per animal and the following anomalies were registered: a) Single Jolly bodies, b) fragments of nuclei in erythrocytes, c) micronuclei in erythroblasts, d) micronuclei in leucopoietic cells, e) polyploid cells.
- Statistics:
- Significance of differences between doses were assessed by chi-square test
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- One female animal of the low-dose group died after the 1st application. Due to lack of dose-dependency and affection of a single animal, a treatment-related but not a substance-related effect is assumed.
- Conclusions:
- Interpretation of results (migrated information): negative
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).
4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13). - Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- One female animal of the low-dose group died after the 1st application. Due to lack of dose-dependency and affection of a single animal, a treatment-related but not a substance-related effect is assumed.
- Conclusions:
- Interpretation of results (migrated information): negative
Referenceopen allclose all
In all treatments with the substance and in the negative control, the mean percentage of anormal cells was 0.1 while the positive control substance caused 10% abnormal cells, indicating the absence of a genotoxic effect in this test system and a suitable sensitivity of the test system (see table).
dose [mg/kg bw] |
average number of cell anomalies per animal |
|
negative control (PEG 400) |
0,1 | |
positive control (Cyclophosphamide) |
128 | 10 |
test substance | 1250 | 0,1 |
test substance | 2500 | 0,1 |
test substance | 5000 | 0,1 |
In all treatments with the substance and in the negative control, the mean percentage of anormal cells was 0.1 while the positive control substance caused 10% abnormal cells, indicating the absence of a genotoxic effect in this test system and a suitable sensitivity of the test system (see table).
dose [mg/kg bw] |
average number of cell anomalies per animal |
|
negative control (PEG 400) |
0,1 | |
positive control (Cyclophosphamide) |
128 | 10 |
test substance | 1250 | 0,1 |
test substance | 2500 | 0,1 |
test substance | 5000 | 0,1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
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 mutagenicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.
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.
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