Registration Dossier
Registration Dossier
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EC number: 616-036-0 | CAS number: 73963-42-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study had been performed in accordance with OECD Giudeline No.:406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The studies were carried out in 2009.
Test material
- Reference substance name:
- 5-(4-chlorobutyl)-1-cyclohexyl-1H-1,2,3,4-tetrazole
- EC Number:
- 616-036-0
- Cas Number:
- 73963-42-5
- Molecular formula:
- C11H19ClN4
- IUPAC Name:
- 5-(4-chlorobutyl)-1-cyclohexyl-1H-1,2,3,4-tetrazole
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Cilostazol Starting Material 2
- Substance type: Pharmaceutical intermediate
- Physical state: white crystalline powder
- Date of analysis: 2009.03.
- Lot/batch No.: PL2488
- Storage condition of test material: in well-closed brown vial at up to 25°C.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LAB-ÁLL Bt. Budapest
- Weight at the beginning of the study: 287-372 g
- Housing: 2-3 animals in 42x42x19 cm macrolon cages
- Diet (e.g. ad libitum): ad libitum,CuniFort Intensive Rabbit Diet Mixture
- Water (e.g. ad libitum): ad libitum, tap water containing 50 mg/100 ml Ascorbic acid.
- Acclimation period: 8 days
- Test group: 10 animals
- Control group: 5 animals
-Sex: male
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: sunflower oil
- Concentration / amount:
- For the intradermal application 0.1 ml formulated test item was injected at concentrations of 0.01, 0.1, 1 and 5% (w/v).
For the dermal application 0.5 ml formulated test item was applied onto the skin of the animals at concentrations os 10, 25 and 50 % (w/v).
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sunflower oil
- Concentration / amount:
- For the intradermal application 0.1 ml formulated test item was injected at concentrations of 0.01, 0.1, 1 and 5% (w/v).
For the dermal application 0.5 ml formulated test item was applied onto the skin of the animals at concentrations os 10, 25 and 50 % (w/v).
- No. of animals per dose:
- In the range finding study: 2-2 animals for intra-dermal and dermal application.
Main study: test groups - 10 animals
control group - 5 animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 % . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information EU
- Conclusions:
- Challenge with test item evoked no positive responses in the test animals sensitised previously. At the same time, none of the animals proved to be positive in the control group. The net response value represented an incidance rate of 0% and the net score value of 0.00. According to the results the substance was classified as a non-sensitizer.
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