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EC number: 607-566-3 | CAS number: 25137-84-2
- 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 12th 2000 - January 8th 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Council Directive 2000/32, Annex 4D.
- Qualifier:
- according to guideline
- Guideline:
- other: ICH S2A Genotoxicity: Specific Aspect of Regulatory Tests
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2’DEOXY-5-ETHYL-URIDINE, 3’5’-BIS(4-CHLOROBENZOATE)
- Physical state: Solid (whitish powder)
- Lot/batch No.: 2/98-G
- Expiration date of the lot/batch: 30th November 2003
- Storage: At room temperature - Target gene:
- TA1535, TA1537, TA98, TA100 and TA102
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- EXPERIMENT I: 5000, 2500, 1250, 625 and 313 µg/plate
EXPERIMENT II: 5000, 2500, 1250, 625 and 313 µg/plate - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- cumene hydroperoxide
- other: 2-Aminoanthracene
- Remarks:
- sterile distilled water
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 30 minutes at 37 °C
- Exposure duration: 72 hours at 37 °C
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity was assessed on the basis of a decline in the number of spontaneous revertants, a thinning of the background lawn or a microcolony formation. The scoring was effected by counting the number of revertant colonies on each plate - Evaluation criteria:
- For the test item to he considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose-levels or at the highest practicable dose-level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels. The effect must be reproduced in an independent experiment
- Statistics:
- A statistical evaluation of the results is not regarded as necessary
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks on result:
- other: EXPERIMENT I: 5000, 2500, 1250, 625 and 313 µg/plate
- Conclusions:
- It is concluded that the test item 2’DEOXY-5-ETHYL-URIDINE, 3’5’-BIS(4-CHLOROBENZOATE) does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions.
- Executive summary:
The test item 2’DEOXY-5-ETHYL-URIDINE, 3’5’-BIS(4-CHLOROBENZOATE) was examined for mutagenic activity by assaying for reverse mutation to histidine prototrophy in the prokaryotic organism Salmonella typhimurium.
The five tester strains TA1535, TA1537, TA98, TA100 and TA102 were used.
Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone.
Test item solutions were prepared using dimethylsulphoxide.
In the toxicity test, the test item was assayed at a maximum dose-level of 5000 µg/plate and at four lower dose-levels spaced at approximately half-log intervals: 1580, 500, 158 and 50.0 µg/plate. No signs of toxicity were observed at any dose-level tested, in any tester strain, in the absence or presence of S9 metabolic activation.
Two main experiments were performed.
In Main Assay I, using the plate incorporation method, the test item was assayed at a maximum dose-level of 5000 µg/plate and at four lower dose-levels, separated by two-fold dilutions: 2500, 1250, 625 and 313 µg/plate.
As no increases in revertant numbers were observed, all treatments of Main Assay II included a pre-incubation step and used the same dose-range employed in Main Assay I. Moderate toxicity was observed at higher dose-levels with all tester strains both in the absence and presence of S9 metabolism.
Precipitation of the test item was observed at higher dose-levels in both experiments.
The test item did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose-level, in any tester strain, in the absence or presence of S9 metabolism.
It is concluded that the test item 2’DEOXY-5-ETHYL-URIDINE, 3’5’-BIS(4-CHLOROBENZOATE) does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The test item 2’DEOXY-5-ETHYL-URIDINE, 3’5’-BIS(4-CHLOROBENZOATE) was examined for mutagenic activity by assaying for reverse mutation to histidine prototrophy in the prokaryotic organismSalmonella typhimurium.
The five tester strains TA1535, TA1537, TA98, TA100 and TA102 were used.
Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone.
Test item solutions were prepared using dimethylsulphoxide.
In the toxicity test, the test item was assayed at a maximum dose-level of 5000 µg/plate and at four lower dose-levels spaced at approximately half-log intervals: 1580, 500, 158 and 50.0 µg/plate. No signs of toxicity were observed at any dose-level tested, in any tester strain, in the absence or presence of S9 metabolic activation.
Two main experiments were performed.
In Main Assay I, using the plate incorporation method, the test item was assayed at a maximum dose-level of 5000 µg/plate and at four lower dose-levels, separated by two-fold dilutions: 2500, 1250, 625 and 313 µg/plate.
As no increases in revertant numbers were observed, all treatments of Main Assay II included a pre-incubation step and used the same dose-range employed in Main Assay I. Moderate toxicity was observed at higher dose-levels with all tester strains both in the absence and presence of S9 metabolism.
Precipitation of the test item was observed at higher dose-levels in both experiments.
The test item did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose-level, in any tester strain, in the absence or presence of S9 metabolism.
It is concluded that the test item 2’DEOXY-5-ETHYL-URIDINE, 3’5’-BIS(4-CHLOROBENZOATE) does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions.
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