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EC number: 927-895-9 | CAS number: 1168150-46-6
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 August - 29 September 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 471) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- CD 352 XX
- IUPAC Name:
- CD 352 XX
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): CD 352 XX
- Physical state: yellow solid substance
- Analytical purity: 99.0 %
- Certificate of analysis: 24 august 2011
- Lot/batch No.: 0002
- Expiration date of the lot/batch: july 2012
- Storage condition of test material: room temperature in the dark (ambient humidity)
Constituent 1
Method
- Target gene:
- S. typhimurium
TA 1537 hisC3076 rfa uvrB - Frameshift
TA 98 hisD3052 rfa uvrB pKM101 Frameshift
TA 100 hisG46 rfa uvrB pKM101 Base substitution
TA 1535 hisG46 rfa uvrB - Base substitution
TA 102 hisG428 rfa + pKM101, pAQ1 Base substitution
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Plate test: 10, 30, 100, 300, 1000 µg/plate of test substance
Preincubation method: 10, 30, 100, 300, 600 µg/plate of test substance - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-aminoanthracene, 2-Aminofluoren
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation) and the preincubation method
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 replications per concentration level - Evaluation criteria:
- The assessment and interpretation of the results follows the OECD Guideline No. 471. In
addition, the historical negative control data ranges experienced in our laboratory were also
considered though for orientating purposes only.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 300 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 100 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: 300 µg/plate plate test and Preincubation method
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Plate test
Any other information on results incl. tables
CD 352 XX did not induce an increase in the number of revertant colonies in different tester strains of S. typhimurium compared to the negative control when tested up to insoluble and/or bacteriotoxic concentrations in the plate test. Furthermore, metabolic activation by S9 mix did not alter the mutation frequency of these bacterial strains. The results were verified in an independent test using the preincubation method.
Bacteriotoxicity prohibited analysis of the number of revertants in some strains at 1000 μg/plate in the plate test.There was no indication for an increase in the number of revertants between 100 and 300 μg/plate where precipiation and signs of bacteriotoxicity were observed. Therefore, it was concluded that the concentration interval was sufficiently close and no further data are needed to confirm the Ames negative response.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation plate test and Preincubation method
negative without metabolic activation plate test and Preincubation method
CD 352 XX caused neither base-pair substitutions nor frameshift mutations in different
S. typhimurium strains in the absence and presence of metabolic activation system when
tested up to insoluble and bacteriotoxic concentrations. Based on these results it was
concluded, that CD 352 XX is "Ames negative".
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