Registration Dossier
Registration Dossier
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EC number: 682-385-0 | CAS number: 917805-74-4
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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The studies were carried out in 2010.
Test material
- Reference substance name:
- tert.butyl amine salt of (+)-(3R, 5S)-7[4-(4-Fluorophenyl)-6-Isopropyl-2 [methyl-(methylsulfonyl amino] pyrimidin-5-yl]-3,5- dihydroxy-6(E)- heptenoic acid
- Cas Number:
- 917805-74-4
- Molecular formula:
- C26H39FN4O6S
- IUPAC Name:
- tert.butyl amine salt of (+)-(3R, 5S)-7[4-(4-Fluorophenyl)-6-Isopropyl-2 [methyl-(methylsulfonyl amino] pyrimidin-5-yl]-3,5- dihydroxy-6(E)- heptenoic acid
- Test material form:
- solid: particulate/powder
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 study initiation: 278-342 g
- Housing: animals were housed in macloron cages, size II., with 3 or 2 animals / cage (42*42*19 cm)
- Diet (e.g. ad libitum): ad libitum, CuniFort Intensive Rabbit Diet Mixture (Tendre Ltd.)
- Water (e.g. ad libitum): ad libitum containing 50 mg/100 ml Ascorbic acid
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- Range finding study: 2 animals/two concentrations (in one animal two concentrations were tested: one concentration in the left side, and other concentration in the right side).
Main study:
- Test groups 10 animals
- Control group 5 animals - Details on study design:
- 10 test animals were subjected to sensitisation procedures in a two-stage operation, i.e. an intra-dermal treatment and a topical application. The test item was used at concentration of 1 % for intra-dermal injections and at concentration of 75 % for dermal sensitisation treatment. Before the dermal exposure the test area was painted with 0.5 ml of 10 % sodium dodecyl 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 (at concentration of 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 the sensitisation phase and they were treated with the test item (at concentration of 75 %) only in the case of challenge.
Results and discussion
- Positive control results:
- Incidence Rate
Positive response was observed in 30% of the test animals after challenge with the test item. Positive response was observed in one control animal (20%) 24 hours after the patch removal.
Intensity of Sensitisation Response
Challenge with the test item elicited discrete erythema in three out of ten animals (30%) on the skin surface of previously sensitized guinea pigs. The mean of the scores were 0.3 and 0.0 according to the 24th and 48th hour observations.
In the control group the mean of the scores were 0.2 and 0.0.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible change
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- discrete or patchy erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no viible change
Applicant's summary and conclusion
- Interpretation of results:
- other: non sensitiser
- Conclusions:
- According to the net percentage value of positively responded animals and to the net score value of the skin reactions, the test item Rosuvastatin TBA salt (EGIS-14660-3) was classified as a non-sensitiser.
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