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EC number: 801-520-8 | CAS number: 102212-98-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-10-23 to 2020-01-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 July 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 5′-O-(4,4′-dimethoxytrityl)-2′-deoxythymidine-3′-O-[O-(2-cyanoethyl)-N,N′-diisopropylphosphoramidite]
- EC Number:
- 685-410-3
- Cas Number:
- 98796-51-1
- Molecular formula:
- C40H49N4O8P
- IUPAC Name:
- 5′-O-(4,4′-dimethoxytrityl)-2′-deoxythymidine-3′-O-[O-(2-cyanoethyl)-N,N′-diisopropylphosphoramidite]
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was placed into an appropriate container on a tared balance and DMF was added (weight per weight). The different test item concentrations were prepared individually. The preparations were made freshly before each dosing occasion.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc, Postbus 6174, 5960 AD Horst, The Netherlands
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks (pre-test), 8 weeks (main study)
- Weight at study initiation: 19.5-20.8 (pre-test), 16.5-20.7 g (main study)
- Housing: Animals were housed in a group, Makrolon Type II (pre-test) / III (main study) cages, with wire mesh top
- Diet: ad libitum, 2018C Teklad Global 18% protein rodent diet (certified)
- Water: ad libitum, tap water
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (20-24)
- Humidity (%): approx. 45-65
- Photoperiod (hrs dark / hrs light): 12/12, artificial light (6.00 a.m.-6.00 p.m.)
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5%, 10%, 25%, 50% (w/w)
- No. of animals per dose:
- - Pre-test: 2 female mice/group
- Main experiment: 5 female mice/group - Details on study design:
- See "Any other information on materials and methods incl. tables" below.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables. Where appropriate, the EC3 value were calculated according to the equation EC3 = (a-c) [(3-d)/(b-d)] + c, where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the S.I. value of 3 on the local lymph node assay dose response plot. All calculations conducted on the DPM values and the ear weights, were performed with a validated test script of “R”, a language and environment for statistical computing and graphics.
Within the program a statistical analysis conducted on the DPM values and the ear weights in order to assess whether the difference was statistically significant between the test item groups and negative control group. Statistical significance was set at the five per cent level (p< 0.05). Additionally, for the DPM values, the Dean-Dixon-Test and Grubb’s Test were used for identification of possible outliers. No outliers were detected in both statistical tests. However, both biological and statistical significance will be considered together.
Results and discussion
- Positive control results:
- α-hexyl cinnamaldehyde dissolved in acetone/olive oil (4+1 v/v) was used as a positive control. The positive control substance exceeded the stimulation index of 3 confirming the sensitivity and reliability of the experimental technique (see Table 2 in box "Any other information on results").
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- mean of five animals
- Value:
- 1.8
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Remarks:
- mean of five animals
- Value:
- 1.4
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Remarks:
- mean of five animals
- Value:
- 2
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Remarks:
- mean of five animals
- Value:
- 1.8
- Test group / Remarks:
- 50%
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
- Please see Table 2 in box "Any other information on results incl. Tables".
EC3 CALCULATION
- The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
CLINICAL OBSERVATIONS:
- No deaths occured during the study period. No signs of systemic toxicity were observed during the study period. From day 1 to 6, the animals showed an erythema of the ear skin (Score 1 to 2). Additionally, scaly ears and fur loss was observed.
BODY WEIGHTS:
- The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Any other information on results incl. tables
Results of vehicle and dose selection:
Solubility test:
The maximum concentration of test item which could be technically used was a 50% solution in DMF.
Pre-test: Irritation and toxicity test:
Two mice were treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 25 and 50% once daily each on three consecutive days. At the tested concentrations the animals did not show any signs of systemic toxicity. From day 2 to 6, the animals showed an erythema of the ear skin (Score 1 to 2). Additionally, fur loss, stiffened ears, scaly ears and erythema of scalp were observed in the animal treated with the high dose of the test item. In the animal treated with the low dose, substance residuals and scaly ears were observed. A maximum increase in ear thickness of 10.4% (animal 1) and 7.5 % (animal 2) was observed. No excessive increase in ear weights was observed in both animals.
Results of the main study:
Table 2: Results of the positive control group
Test item (alpha-Hexylcinnamaldehyde) Concentration [%] | Group | Result Stimulation Index |
- | background | - |
- | background | - |
0 | 1 | 1.00 |
5 | 2 | 1.68 |
10 | 3 | 1.78 |
25 | 4 | 8.19 |
Table 3: Results of the main experiment
Group calculation | ||||||||
Test item (DMT-dT-Phosphoramiditite) concentration [%] | Group Number | Animal Number | DPM values measured | DPM−BG per animal (2 lymph nodes) | Stimulation Index | Mean DPM per animal (2 lymph nodes) | standard deviation | Stimulation Index |
- | - | background 1 | 13 | - | - | - | - | - |
- | - | background 2 | 21 | - | - | - | - | - |
Vehicle Control Group (DMF) | 1 | 1 | 1457 | 1440 | - | 2378.0 | 709.0 | 1.0 |
1 | 2 | 2352 | 2335 | - | ||||
1 | 3 | 2588 | 2571 | - | ||||
1 | 4 | 3414 | 3397 | - | ||||
1 | 5 | 2164 | 2147 | - | ||||
5% DMT-dT-Phosphoramidite | 2 | 6 | 3310 | 3293 | 1.4 | 4323.0 | 1598.8 | 1.8 |
2 | 7 | 2841 | 2824 | 1.2 | ||||
2 | 8 | 3492 | 3475 | 1.5 | ||||
2 | 9 | 6526 | 6509 | 2.7 | ||||
2 | 10 | 5531 | 5514 | 2.3 | ||||
10% DMT-dT-Phosphoramidite | 3 | 11 | 1863 | 1846 | 0.8 | 3287.8 | 1085.6 | 1.4 |
3 | 12 | 3225 | 3208 | 1.3 | ||||
3 | 13 | 2798 | 2781 | 1.2 | ||||
3 | 14 | 4716 | 4699 | 2.0 | ||||
3 | 15 | 3922 | 3905 | 1.6 | ||||
25% DMT-dT-Phosphoramidite | 4 | 16 | 2049 | 2032 | 0.9 | 4849.0 | 1867.8 | 2.0 |
4 | 17 | 4839 | 4822 | 2.0 | ||||
4 | 18 | 4394 | 4377 | 1.8 | ||||
4 | 19 | 6138 | 6121 | 2.6 | ||||
4 | 20 | 6910 | 6893 | 2.9 | ||||
50% DMT-dT-Phosphoramidite | 5 | 21 | 2528 | 2511 | 1.1 | 4270.4 | 1302.9 | 1.8 |
5 | 22 | 5766 | 5749 | 2.4 | ||||
5 | 23 | 3460 | 3443 | 1.4 | ||||
5 | 24 | 5165 | 5148 | 2.2 | ||||
5 | 25 | 4518 | 4501 | 1.9 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, in a mouse local lymph node assay, the test item DMT-dT-Phosphoramidite is not to be considered a skin sensitizer under the test conditions of this study.
- Executive summary:
In a dermal sensitization study conducted according to OECD 429, five young adult female CBA/CaOlaHsd mice per dose group were dermally exposed to DMT-dT-Phosphoramidite in DMF at concentrations of 5%, 10% and 25% and 50% (w/w) by topical application to the dorsum of each ear for three consecutive days and observed until day 6 in a local lymph node assay (LLNA). α-hexyl cinnamaldehyde dissolved in acetone/olive oil (4+1 v/v) was used as a positive control. The positive control substance exceeded the stimulation index of 3 at the highest dose tested (25%).
No signs of systemic toxicity were observed during the study period. From day 1 to 6, the animals showed an erythema of the ear skin (Score 1 to 2). Additionally, scaly ears and fur loss was observed.
No mortality or effects on body weight occurred during the study. None of the four tested concentrations exceeded a stimulation index of 3 (1.8 (5%), 1.4 (10%) and 2.0 (25%) and 1.8 (50%)). As a consequence, an EC3 value could not be calculated. In this study, DMT-dT-Phosphoramidite is not a dermal sensitizer.
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