Registration Dossier
Registration Dossier
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EC number: 413-410-3 | CAS number: 88150-62-3
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Phthaloyl Amlodipine
- Substance type: Pharmaceutical intermediate
- Physical state: pale yellow crystalline substance
- Purity test date: 09-05-2006
- Lot/batch No.: 130306
- Expiration date of the lot/batch: May 2007
- Storage condition of test material: in brown powder-flask, at room temperature and dry
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LAB-ÁLL Bt. Budapest
- Weight at study initiation: 280-348 g
- Housing: 2-3 animals in 42x42x19 cm macrolon cages
- Diet (e.g. ad libitum): ad libitum, PURINA-Base - Lap gr. diets for rabbits
- Water (e.g. ad libitum): ad libitum, potable water containing 50 mg/100 ml Ascorbic acid.
- Acclimation period: 20 days
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:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75 (w/v) % in carboxymethyl cellulose 1 % aqueous solution for dermal induction treatment, and 25 % for the challenge treatment
1 % for the intradermal treatment
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75 (w/v) % in carboxymethyl cellulose 1 % aqueous solution for dermal induction treatment, and 25 % for the challenge treatment
1 % for the intradermal treatment
- No. of animals per dose:
- In the range finding study: 2 animals / 2 concentrations (2 concentrations in 1 animal: one on the right side and the other on the left side)
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:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- 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: 25 % . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- 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: 25 %. 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:
- 25 %
- 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: 25 %. 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:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
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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