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EC number: 618-507-6 | CAS number: 90213-66-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 17, 2007 to February 23, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2,4-dichloro-7H-pyrrolo[2,3-d]pyrimidine
- EC Number:
- 618-507-6
- Cas Number:
- 90213-66-4
- Molecular formula:
- C6H3Cl2N3
- IUPAC Name:
- 2,4-dichloro-7H-pyrrolo[2,3-d]pyrimidine
- Test material form:
- solid
- Details on test material:
- White to yellow tan colour
Constituent 1
- Specific details on test material used for the study:
- Identity: CP-902684
Batch No.: E010005632 or 166-TNN-73
Aggregate state at room temperature: Solid
Colour: Tan
Purity: 98 %
Stability in solvent: Not indicated by the sponsor
Storage: At room temperature
Expiration Date: March 21, 2009
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Test system: Mice, CBA/CaOlaHsd
Rationale: Recognised as the recommended test system
Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst / The Netherlands
Number of animals for the pre-test: 2 females
Number of animals for the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Age: 10 - 12 weeks (beginning of treatment)
Identification: Single caging. The animals were distributed into the test groups at random and identified by cage number.
Acclimatisation: 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.
Housing: single
Cage Type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
Bedding: granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen)
Feed: pelleted standard diet, ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen)
Water: tap water, ad libitum, (Gemeindewerke, D-64380 Rossdorf)
Environment: temperature 22 +3°C, relative humidity 30-70%, artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 5, 10 and 25 %
- No. of animals per dose:
- 4 females (nulliparous and non-pregnant)
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which can be technically used was a 25 % solution in dimethylsulfoxide.
- Irritation: To determine the highest non-irritant test concentration, a pre-test was performed in two animals. Two mice were treated with concentrations of 2.5, 5, 10, and 25 % on one ear each on three consecutive days. Clinical signs were recorded 24 ± 4 hours after each application. At the tested concentrations the animals did not show any signs of irritation or systemic toxicity.
- Systemic toxicity: The test item in the main study was assayed at 5, 10, and 25%. The top dose is the highest technically achievable concentration; this concentration also avoided systemic toxicity and excessive local irritation. No severe irritant effects were tolerated choosing the test concentrations.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT : The animals were distributed into the test groups at random and identified by cage number. 4 animals were assigned per group. Animals were distributed to the respective dose groups starting with the vehicle control and continuing with increasing test item concentrations.
- Name of test method: LLNA
- Criteria used to consider a positive response: A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 5, 10, and 25% (w/v) in dimethylsulfoxide. The application volume, 25 Rl, was spread over the entire dorsal surface (~ 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals). - 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, a statistical analysis will be conducted for assessment of the dose-response relationship, and the EC3 value will be 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.
Results and discussion
- Positive control results:
- Calculation
Measurement DPM DPM-BG No. of lympt nodes DPM per lymph node
5421 5384 8 672.9
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.29
- Test group / Remarks:
- 5 % (w/v)
- Key result
- Parameter:
- SI
- Value:
- 3.03
- Test group / Remarks:
- 10 % (w/v)
- Key result
- Parameter:
- SI
- Value:
- 6.32
- Test group / Remarks:
- 25 % (w/v)
- Cellular proliferation data / Observations:
DETAILS ON STIMULATION INDEX CALCULATION
EC3 CALCULATION : the EC3 value is calculated according to the equation:
EC3 = (a-c) [(3-d)/(b-d)] + c
The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
CLINICAL OBSERVATIONS: The animals did not show any clinical signs of toxicity after the first and second application. After the third application the low dose (5%) induced slight redness of the ear skin of all 4 animals of the group. At higher concentrations a similar effect was not observed.
BODY WEIGHTS: The body weight of the animals, recorded prior to the first application and prior to treatment with and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item CP-902684 was found to be not a skin sensitiser under the described conditions.
- Executive summary:
In the study the test item CP-902684 dissolved in dimethylsulfoxide was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25%. The animals did not show any clinical signs of toxicity after the first and second application. After the third application the low dose (5 %) induced slight redness of the ear skin of all 4 animals of the group. At higher concentrations similar effects were not observed. In this study Stimulation Indices (S.I.) of 1.89, 1.86 and 2.21 were determined with the test item at concentrations of 5, 10, and 25% in dimethylsulfoxide, respectively. The test item CP-902684 was not a skin sensitiser in this assay.
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