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EC number: 440-850-3 | CAS number: 27311-52-0
- 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
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- 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
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- 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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to the OECD Guideline and GLP
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
- Reference Type:
- other: abstract
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 92/69, L 383 A, Annexe V, B 14
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- Ro 1525 corresponds to Colipa A 155
Ro 1525
SAT 9803 75
Batch-No.: Ro-Rn 6567-083
Method
- Target gene:
- TA1537: his C 3076; da-; uvrB- frame shift mutations
TA 98: his D 3052; rfa-; uvrB-;R-factor frame shift mutations
TA1535: his G 46; rfa-; uvrB- base-pair substitutions
TA 100: his G 46; rfa-; uvrB;R-factor base-pair substitutions
TA 102: his G 428; rfa'; uvrB';R-factor base-pair substitutions
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium strain: TA 98, TA 100, TA 102, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitallß-Naphthoflavone induced rat liver S9 is used as the metabolic activation system. The S9 is prepared from 8 - 12 weeks old male Wistar Hanlbm rats.
- Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 2500 and 5000 ug/plate
- Vehicle / solvent:
- deionised water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: sodium azide (TA1535, TA 100), 4-nitro-o-phenylene-diamine (TA 1537, TA 98), methyl methane sulfonate (TA 102). With metabolic activation: 2-aminoanthracene (all strain)
- Details on test system and experimental conditions:
- The histidine dependent strains are derived fiom S. typhimurium strain LT2 through a
mutation in the histidine locus. Additionally due to the "deep rough" (rfa-minus) mutation
they possess a faulty lipopolysaccharide envelope which enables substances to penetrate the
cell wall more easily. A hrther mutation causes an inactivation of the excision repair
system. The latter alteration includes mutational processes in the nitrate reductase and biotin
genes produced in a UV-sensitive area of the gene named "uvrB-minus". In the strains TA
98 and TA 100 and TA 102 the R-factor plasmid pKM 10 1 carries the ampicillin resistance
marker. The strain TA 102 does not contain the uvrB--mutation and is excision repair
proficient. Additionally, TA 102 contains the multicopy plasmid pAQ 1 carrying the hisG428
mutation (ochre mutation in the hisG gene ) and a tetracycline resistance gene. - Evaluation criteria:
- Regular checking of the properties of the strains regarding the membrane permeability,
ampicillin- and tetracycline-resistance as well as spontaneous mutation rates is performed in
the laboratory of RCC Cytotest Ce11 Research according to Ames et al. (1). In this way it
was ensured that the experimental conditions set down by Arnes were fulfilled.
Results and discussion
Test results
- Species / strain:
- other: TA 98, TA 100, TA 102, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Salmonella typhimurium
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described mutagenicity test and under the
experimental conditions reported, the test article did not induce gene mutations by base pair
changes or fiamechifis in the genome of the strains used.
with S9 mix
/
without S9 mix
1000 - 5000
Therefore, Ro 1525 is considered to be non-mutagenic in this Salmonella typhimurium
reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of Ro 1525 to induce gene mutations
according to the plate incorporation test (experiment I) and the pre-incubation test
(experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98,
TA 100. and TA 102.
The assay was performed in two independent experiments both with and without h e r
microsomal activation. Each concentration, including the controls, was tested in triplicate.
The test article was tested at the following concentrations:
33; 100; 333; 1000; 2500; and 5000 pg/plate
The background growth was reduced at concentrations as low as 333 pglplate in the first
and at 100 pg/plate and above in the second experiment without metabolic activation.
No substantial increase in revertant colony numbers of any of the five tester strains was
observed following treatment with Ro 1525 at any dose level, neither in the presence nor
absence of metabolic activation (S9 mix). There was also no tendency of higher mutation
rates with increasing concentrations in the range below the generally acknowledged border
of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase
of induced revertant colonies.
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