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EC number: 204-464-7 | CAS number: 121-32-4
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 29 apr 2003 to 06 oct 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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:
- 3-ethoxy-4-hydroxybenzaldehyde
- EC Number:
- 204-464-7
- EC Name:
- 3-ethoxy-4-hydroxybenzaldehyde
- Cas Number:
- 121-32-4
- Molecular formula:
- C9H10O3
- IUPAC Name:
- 3-ethoxy-4-hydroxybenzaldehyde
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L'Arbresle, France.
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: 21.7 +/- 1.4 g
- Housing: individually in disposable crystal polystyrene cages (22*8.5*8 cm)
- Diet (e.g. ad libitum): free access to A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (e.g. ad libitum): free access to tap water (filtered using a 0.22 micron filter) contained in bottles.
- Acclimation period: at least 5 days before the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): 12 cycles per hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12h / 12h
IN-LIFE DATES: From 05 jun 2003 to 10 jun 2003
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 2.5, 5, 10, 25 and 50 %
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: the test item was freely soluble in the vehicle, consequently, the concentrations selected for the preliminary test were 5, 10, 25 and 50%.
- Irritation: no cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals of the treated groups.
- Lymph node proliferation response: no. No positive lymphoproliferative response was noted and no dose-related increase in the stimulation index was observed at the tested concentrations.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: animals will be assigned to the treatment groups by hand procedure. Identification is individually by a number on the tail using an indelible marker.
- Criteria used to consider a positive response: The test item should be regarded as a skin sensitizer when the SI for a dose group is >=3. Other relevant criteria such as cellularity, radioactivity levels and ear thickness will be also taken into account to evaluate the data.
When appropriate, the EC3 value (theoretical concentration resulting in a SI value of 3) will be determined by linear interpolation of points on the dose-response curve, immediately above and below the 3-fold threshold. The equation used for calculation of EC3 will be:
EC3 = c + [(3 - d)/(b - d)] x (a - c)
Where a = the lowest concentration giving stimulation > 3; b = the actual stimulation index caused by a; c = the highest concentration failing to produce a stimulation index of 3; and d = the actual stimulation index caused by c.
TREATMENT PREPARATION AND ADMINISTRATION: 28 female mice were allocated to 7 groups: five treated groups (2.5, 5, 10, 25 and 50%), one negative control group (vehicle), one positive control group (HCA).
On days 1, 2 and 3, a dose-volume of 25 µL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No
Results and discussion
- Positive control results:
- SI = 13.5 with 25% of hexyl cinnamic aldehyde
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Per node: from 135 to 116.
- Parameter:
- SI
- Value:
- 1.87
- Test group / Remarks:
- 2.5% / 4 animals
- Parameter:
- SI
- Value:
- 1.71
- Test group / Remarks:
- 5% / 4 animals
- Parameter:
- SI
- Value:
- 1.44
- Test group / Remarks:
- 10% / 4 animals
- Parameter:
- SI
- Value:
- 1.42
- Test group / Remarks:
- 25% / 4 animals
- Parameter:
- SI
- Value:
- 1.61
- Test group / Remarks:
- 50% / 4 animals
Any other information on results incl. tables
Groups | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Concentrations (%) | 0 (Acetone/olive oil) |
2,5 | 5 | 10 | 25 | 50 | HCA at 25% |
Cell count viable | 66 | 100 | 142 | 78 | 118 | 102 | 192 |
Cell count dead | 10 | 9 | 14 | 9 | Il | 10 | 27 |
Viability (%) | 86.84 | 91.74 | 91.03 | 89.66 | 91.47 | 91.07 | 87.67 |
Amount of cells (*106) cells) | 3.3 | 5.00 | 7.10 | 3.90 | 5.90 | 5.1 | 19.2 |
Cellularity index | 1.52 | 2.15 | 1.18 | 1.79 | 1.55 | 5.82 | |
Number of nodes per group | 8 | 8 | 8 | 8 | 8 | 8 | 8 |
Disintegrations per min per gp (dpm) | 579.34 | 1083.16 | 989.82 | 833.98 | 822.97 | 930.8 | 7820.28 |
Disintegrations per min per node (dpm) | 72.42 | 135.4 | 123.73 | 104.25 | 102.87 | 116.35 | 977.54 |
stimulation index (SI) | 1.87 | 1.71 | 1.44 | 1.42 | 1.61 | 13.5 | |
Increase in ear thickness (% between day 1 and day 6) | 0.00 | 1.98 | 6.86 | 7.84 | 4.85 | -2.91 | |
EC3 value | NA |
- Positive control results:at the concentration of 25%, a moderate increase in cellularity and a stimulation index exceeding the threshold value of 3 (SI=13.50) was noted. The study was therefore considered valid.
Local irritation:
No cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals at any of the tested concentrations.
Proliferation assay:
In the treated groups, no positive lymphoproliferative response was noted and no dose-related increase in the stimulation index was observed at the tested concentrations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not sensitizing
- Executive summary:
In a dermal sensitization study (Klein, 2003) with Ethylvanillin in acetone/olive oil (4/1), female CBA/J mice (4 animals per dose) were tested in LLNA, according to the guideline OECD 429 at doses: 0, 2.5, 5, 10, 25 and 50 %.
During the study, no cutaneous reactions (ears irritation) were observed, nor a positive lymphoproliferative response.
In absence of effect no EC3 value could be calculated.
Based on these results, Ethylvanillin is not sensitizing according to CLP 1272/2008/EC criteria.
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