Registration Dossier
Registration Dossier
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EC number: 601-680-7 | CAS number: 120202-68-8
Toxicological information
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: Well documented study according to international accepted guidelines and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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 substance name:
- [(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonic acid; methyl (2S)-2-(2-chlorophenyl)-2-{4H,5H,6H,7H-thieno[3,2-c]pyridin-5-yl}acetate
- EC Number:
- 601-680-7
- Cas Number:
- 120202-68-8
- Molecular formula:
- C16H16ClNO2S.C10H16O4S
- IUPAC Name:
- [(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonic acid; methyl (2S)-2-(2-chlorophenyl)-2-{4H,5H,6H,7H-thieno[3,2-c]pyridin-5-yl}acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Clopidogrel 5th intermediate (K-salt)
Batch No: CL-141
Appearance: almost white, crystalline powder
Storage: at room temperature
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, Hungary
- Weight at study initiation: 305-365 g
- Housing: 2-3 animals in 42x42x19 cm macrolon cages
- Diet (e.g. ad libitum): ad libitum, PUNIPLUS standard diet for rabbits (AGRIBRAND)
- Water (e.g. ad libitum): ad libitum, potable water containing 50 mg/100 ml Ascorbic acid.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Rate of air exchange: 13-17/hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: methylcellulose (1 %)
- Concentration / amount:
- 75 (w/v) % in ethyl alcohol 20 % aqueous solution for dermal induction treatment and for the challenge treatment,
0.01 % for the intradermal treatment using Freund's complete adjuvant and physiological saline.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: methylcellulose (1 %)
- Concentration / amount:
- 75 (w/v) % in ethyl alcohol 20 % aqueous solution for dermal induction treatment and for the challenge treatment,
0.01 % for the intradermal treatment using Freund's complete adjuvant and physiological saline.
- 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 - Details on study design:
- 10 test animals were subjected to sensitization procedures in a two stage operation, i.e. intradermal treatment and a topical application.
The test item was used in concentration of 0.01% for intradermal injections and in concentration of 75 % (w/v) for dermal sensitization treatment. Before Before the dermal exposure the test area was painted with 0.5 ml of 10% sodium lauryl sulphate in vaseline 24 h prior to the topical induction application, in order to create a local irritation.
Two weeks following the last induction exposure, a challenge dose (in concentration 75%) was administered. Challenge was performed by dermal application of the test item - Challenge controls:
- 5 control guinea pigs were simultaneously exposed to vehicle during induction treatments and they were treated with the test item on the challenge day only.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 w/v%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 w/v%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 w/v%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 w/v%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 w/v%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 w/v%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 w/v%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 w/v%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the result of the present study, the test item was classified as no sensitizer.
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