Registration Dossier
Registration Dossier
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EC number: 608-497-1 | CAS number: 3056-13-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.02.2004 - 02.04.2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- [(2S,3R,5S)-3-[(4-methylbenzoyl)oxy]-5-(5-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)tetrahydrofuran-2-yl]methyl 4-methylbenzoate
- EC Number:
- 608-497-1
- Cas Number:
- 3056-13-1
- Molecular formula:
- C26 H26 N2 O7
- IUPAC Name:
- [(2S,3R,5S)-3-[(4-methylbenzoyl)oxy]-5-(5-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)tetrahydrofuran-2-yl]methyl 4-methylbenzoate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Germany
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 15.5 - 20.5 g
- Housing: Animals were housed individually in Makrolon type II cages and aspen wood chips as bedding material.
- Diet: Altromin 1324 forte (Altromin, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22.1
- Humidity (%): average of 42.5
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5% (v/v), 10% (v/v) and 18.7% (w/v) test substance in DMF
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 18.7% is the maximum achievable concentration suitable for administration.
- Irritation: No excessive local skin irritation was observed up to the highest dose tested (18.7%).
MAIN STUDY
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance was solved in N,N-Dimethylformamide (DMF) and was administered to three groups of 5 female CBA/Ca mice. Administration was performed epicutaneously to the dorsal surface of both ears, once a day on three consecutive days (Days 1-3). The volume administered was 25 μL per ear. On Day 6, 20 µCi ³HTdR was injected to all mice via tail vein. After 5 h, the drainig auricular lymph nodes were excised and pooled for each group. A single cell suspension was prepared and incorporation of ³HTdR was determined with a β-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: group A (5% test substance): 0.9 group B (10% test substance): 1.6 group C (18.7% test substance): 1.8 negative control group: 1.0 positive control group: 10.1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: group A (5% test substance): 1422 dpm group B (10% test substance): 2546 dpm group C (18.7% test substance): 2936 dpm negative control group: 1608 dpm positive control group: 16228 dpm
Any other information on results incl. tables
All animals survived until the end of the study period. No adverse effects were noted in all animals of all test substance groups and the negative control group. Moderate erythema formation was noted in all animals of the positive control group on Days 2 and 3, indicating slight local skin irritation.
No skin irritating effects were observed in the test substance groups and the negative control group throughout the whole study period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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