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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 31st, 2000 - December 15st, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Uridine, 2'-deoxy-5-ethyl-, 3',5'-bis(4-chlorobenzoate)
- EC Number:
- 607-566-3
- Cas Number:
- 25137-84-2
- Molecular formula:
- C25H22Cl2N2O7
- IUPAC Name:
- Uridine, 2'-deoxy-5-ethyl-, 3',5'-bis(4-chlorobenzoate)
- Test material form:
- solid: particulate/powder
Constituent 1
- 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 crystalline powder)
- Lot/batch No.: 2/98-G
- Expiration date of the lot/batch: 30th November 2003
- Storage: At room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: supplied by, Charles River Italia S.p.A., (Como) and bred by P.O.A.D.A. Mandello Lario (CO)
- Age at study initiation: approximately 8 to 10 weeks
- Sex: females
- Weight at study initiation: 2 Kg
- Housing: stainless steel cages measuring 69 x 45 x 51 cm
- Diet: anti-biotic free pelleted laboratory diet (Altromin MSK, A. Rieper, Bolzano, Italy) ad libitum
- Water: drinking water ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 21
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light : 12 hours light /12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0,5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 hours after dosing
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
A 0.5 g aliquot of the test item was mixed to a paste using 2.0 mL of distilled water and spread evenly over a gauze square measuring 2.5x2.5 cm. The gauze square was then placed onto the animal’ s skin with the test item in direct contact with the skin. A strip of aluminium foil was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: The treated site was cleaned by gentle swabbing of the skin with cotton wool soaked in water at approximate body temperature.
- Time after start of exposure: 4 h
SCORING SYSTEM:
Erythema and eschar formation Value
No erythema 0
Very slight erythema (barely perceptibie) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema 4
Oedema formation Value
No oedema 0
Very slight oedema (barely perceptibie) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritation or other reaction was apparent on the treated skin of any animal.
- Other effects:
- - Other adverse systemic effects: There was no indication of a systemic effect of treatment
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of this study indicate that the test item, 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate), has no irritant effect on the skin of the rabbit.
- Executive summary:
The acute dermal irritation of 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate) was investigated in the rabbit.
A 0.5 g aliquot of the substance was applied to the prepared dorsal skin of 3 animals for a period of 4 hours. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours after the end of the exposure period.
No irritation was apparent following a 4 hour period of exposure to the substance.
There was no indication of a systemic effect of treatment.
Body weight changes were not remarkable.
These results indicate that 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate) has no irritant effect on the skin of the rabbit.
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