Registration Dossier
Registration Dossier
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EC number: 280-349-5 | CAS number: 83261-15-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Isobutyl (S)-2-chloropropionate
- EC Number:
- 280-349-5
- EC Name:
- Isobutyl (S)-2-chloropropionate
- Cas Number:
- 83261-15-8
- Molecular formula:
- C7H13ClO2
- IUPAC Name:
- isobutyl (S)-2-chloropropanoate
- Details on test material:
- - Name of test material (as cited in study report): L-Chlorpropionsaeureisobutylester
- Analytical purity: 99.8 corr.-area-%
- Lot/batch No.: B 762 of 28.05.08
- Storage condition of test material: The stability under storage conditions over the study period was guaranteed by the manufacturer, and the manufacturer holds this responsibility.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: 6 – 12 weeks
- Weight at study initiation: 18.7 g – 22.9 g
- Housing: single housed, Makrolon cage type II
- Diet: Kliba-Labordiaet (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: 14 days before the first test-substance application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 3%, 10%, 50%
- No. of animals per dose:
- 5
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION: The test-substance preparation was produced on a weight per weight basis shortly before the application. After stirring on a magnetic stirrer the test substance was soluble in the vehicle.
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- When applied as 50% preparation in MEK, the test substance induced a biologically relevant response (increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts. There was no concentration response relation. There was a definitive increase in lymph node weights as well, without clear cut concentration response relation. Contrary to the cell count, the concentration-dependent increase of 3H-thymidine incorporation into the cells was not biologically relevant (no increase above the cut off stimulation index of 3) at the high concentration. All test-substance preparations did not cause an increase in ear weights. Due to the biologically relevant increases in lymph node cell counts and due to the concentration-response relationship in 3H-thymidine incorporation all without the presence of ear skin reaction the results indicate that a skin sensitizing potential of the test substance cannot be excluded. The estimated concentration that leads to the SI of 1.5 for cell count (EC 1.5) and the estimated concentration that leads to the SI of 3.0 for 3H-thymidine incorporation (EC 3) was calculated by linear regression from the results of the 30% and 50% concentrations to be 43.8% and 65.0%, respectively.
Any other information on results incl. tables
| Test group | Treatment | Cell Count Stimulation Index | 3H-thymidine Incorporation Stimulation Index | Lymph Node Stimulation Index | Ear Weight Stimulation Index |
| 1 | vehicle | 1 | 1 | 1 | 1 |
| 2 | 3% | 0.91 | 0.92 | 0.93 | 0.98 |
| 3 | 10% | 0.98 | 1.14 | 1.09 | 1.02 |
| 4 | 50% | 1.73 | 2.2 | 1.55 | 0.99 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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