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EC number: 685-519-6 | CAS number: 93183-15-4
- 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
No data is available for the target substance Guanosine, 5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxy-N-(2-methyl-1-oxopropyl)-, 3′-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite]. Thus, data from a suitable read-across partner was used to assess the genotoxic potential of the target substance.
The mutagenic potential of 5’-O-[bis(4-methoxyphenyl)phenylmethyl]-2’-deoxythymidine, 3’-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite] (source substance) was investigated in a bacterial reverse gene mutation assay conducted according to OECD 471 with and without metabolic activation. There was no increase of mutant colonies compared to the negative control observed in all strains. Consequently, the test item is considered to be non-mutagenic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102, TA1535 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. Precipitation of the test item was observed in all tester strains used in experiments I and II at the higher concentrations of 2500 µg and 5000 µg/plate (with and without metabolic activation).
No toxic effects of the test item were noted in any of the five tester strains up to the highest concentration evaluated with and without metabolic activation inexperiments I and II. No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the test item at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II. All criteria of validity were met. - Remarks on result:
- other: Experiment II, precipitation was observed in all tester strains at 2500 and 5000 µg/plate
- Conclusions:
- Under the experimental conditions reported, 5’-O-[bis(4-methoxyphenyl)phenylmethyl]-2’-deoxythymidine, 3’-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite] did not cause gene mutations in an Ames Test conducted according to OECD 471. Therefore, the test item is considered to be non-mutagenic in this bacterial reverse gene mutation assay.
- Executive summary:
In a bacterial reverse gene mutation assay conducted according to OECD guideline 471, strains TA98, TA100, TA102, TA1535 and TA1537 of Salmonella typhimurium were exposed to 5’-O-[bis(4-methoxyphenyl)phenylmethyl]-2’-deoxythymidine, 3’-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite] (99.7% purity) in DMSO at concentrations of 31.6, 100, 316, 1000, 2500 and 5000 µg/plate in the presence and absence of mammalian metabolic activation. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background in all tester strains in both experiments (plate incorporation and pre-incubation). Based on the results, the test item is considered to be non-mutagenic in the bacterial reverse gene mutation assay.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.51001; OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across report (see IUCLID section 13).
Reference
Table 2: Results of the pre-experiment
Substance |
Dose (µg/plate) |
TA98 |
TA100 |
||||||
Mutation Factor |
Mutation Factor |
||||||||
without S9 |
with S9 |
without S9 |
with S9 |
||||||
Solvent Control (DMSO) |
|
1.0 |
|
1.0 |
|
1.0 |
|
1.0 |
|
4-NOPD |
10.0 |
23.2 |
|
- |
|
- |
|
- |
|
NaN3 |
10.0 |
- |
|
- |
|
8.3 |
|
- |
|
2-AA |
2.50 |
- |
|
58.3 |
|
- |
|
22.0 |
|
Test Item |
3.16 |
0.7 |
|
0.9 |
|
1.2 |
|
1.1 |
|
10.0 |
0.9 |
|
0.8 |
|
1.1 |
|
1.1 |
|
|
31.6 |
1.2 |
|
0.8 |
|
1.0 |
|
1.1 |
|
|
100 |
1.1 |
|
0.9 |
|
1.1 |
|
1.1 |
|
|
316 |
0.8 |
|
1.1 |
|
1.0 |
|
1.0 |
|
|
1000 |
1.3 |
|
0.9 |
|
0.9 |
|
1.2 |
|
|
2500 |
0.8 |
|
0.8 |
|
1.2 |
|
1.2 |
|
|
5000 |
0.6 |
|
0.9 |
|
1.1 |
|
1.1 |
|
*Mutation factor= mean revertants (test item)/ mean revertants (vehicle control)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data is available for the target substance Guanosine, 5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxy-N-(2-methyl-1-oxopropyl)-, 3′-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite]. Thus, data from a suitable read-across partner was used to assess the genotoxic potential of the target substance. Details on the the read-across rationale are provided in IUCLID section 13.
The mutagenic potential of 5’-O-[bis(4-methoxyphenyl)phenylmethyl]-2’-deoxythymidine, 3’-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite] (source substance) was investigated in a bacterial reverse gene mutation assay conducted according to OECD 471 with and without metabolic activation. There was no increase of mutant colonies compared to the negative control observed in all strains. Consequently, the test item is considered to be non-mutagenic.
Justification for classification or non-classification
Based on the available data, the target substance Guanosine, 5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxy-N-(2-methyl-1-oxopropyl)-, 3′-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite] does not warrant classification for mutagenicity.
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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