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EC number: - | CAS number: -
- Life Cycle description
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- Endpoint summary
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study initiation date - 30 April 2021; Experiment start date - 30 April 2021; Experiment end date - 17 June 2021; Study completion date - 02 July 2021.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test Item: FAT 75637/B TE
Physical Appearance: Light yellow powder
Purity: 99.4 % all organic constituents; 95.0 % main constituent
Batch No: AT-0063765400
Manufactured Date: 21st April 2020
Expiry Date: May 27th, 2025
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Mice were housed in an environment-controlled room at 20 to 23 °C and relative humidity of 65 to 67 percent. The photoperiod was 12 hours light and 12 hours darkness, light hours being 06:00 to 18:00 hours approximately. Adequate fresh air supply of 12.8 air changes/hour was maintained in the experimental room. The maximum and minimum temperature and relative humidity in the experimental room were recorded once daily. The relative humidity in the experimental room was calculated daily from dry and wet bulb temperature recordings. Animals were housed individually (to avoid licking of test item by cage mates) in solid floor standard polysulfone cages (Size: Approximately L 360 x B 205 x H 140 mm), with stainless steel top grill having facilities for providing pelleted food and drinking water in polycarbonate bottle with stainless steel sipper tubes. Steam sterilized corn cob was used as bedding and changed along with the cage once a week. Cages were placed on tiered racks. Mouse huts were provided in the cages as environment enrichment to minimize animal stress and promote overall well-being during the in-life phase of the study.
Study design: in vivo (LLNA)
- Vehicle:
- other: 1 % Pluronic® L92 (1% L92)
- Concentration:
- 1 % v/v
- No. of animals per dose:
- 5 groups
Vehicle control (G1)
Positive control (G2)
Test item: Three concentrations (G3 to G5)
Six female mice per dose - Details on study design:
- LLNA main study: Six female CBA/Ca mice per group received the vehicle (1 % L92) or 25 % α-hexylcinnamaldehyde (HCA: positive control in 1 % L92) or 10, 25 and 50 % w/v of test item in 1 % L92 on days 1 to 3. On day 6, the uptake of 3H-methyl thymidine into the auricular lymph nodes draining the site of test item application was measured five hours post administration. Proper conduct of the LLNA was confirmed via a positive response using 25 % α-hexylcinnamaldehyde, a contact sensitizer, which elicited proliferation with a Stimulation Index (SI) value of 6.39, in comparison to vehicle-treated mice.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A mean dpm value ± SD (standard deviation) was calculated for each group and the stimulation index (SI) was calculated using the absolute dpm value for each mouse as the numerator, and the mean dpm value from the vehicle-treated mice as the denominator.
1. The % increase in ear thickness was calculated for each ear using the following equation:
% Ear swelling = (B – A)/A x 100
Where, A = ear thickness measurement on Day 1 (µm); B = ear thickness measurement on Day 3 or 6 (µm)
2. The SI was calculated for each mouse using the following equation:
SI = Disintegrations per minute (dpm) of individual mouse/ Average dpm of the vehicle control mice.
Means and SD were generated for body weight data (absolute and gain) and LLNA response (dpm and SI values). The body weight and dpm data were analysed by one-way analysis of variance. When the differences were indicated by the ANOVA, a comparison of treated vs. control groups was done using a Dunnett’s t-test (p <0.05).
Results and discussion
- Positive control results:
- 25 % α-hexylcinnamaldehyde, a contact sensitizer, which elicited proliferation with a Stimulation Index (SI) value of 6.39, in comparison to vehicle-treated mice.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.08
- Test group / Remarks:
- 10 %
- Parameter:
- SI
- Value:
- 1.22
- Test group / Remarks:
- 25 %
- Parameter:
- SI
- Value:
- 1.5
- Test group / Remarks:
- 50 %
Any other information on results incl. tables
Irritation Screening Test: Once daily topical applications of vehicle – 1 % Pluronic L92 (1 % L92), 5, 10, 20, 35 and 50 % w/v test item in 1 % L92 were performed to one animal at each dose level for 3 days. There were no clinical signs, no erythema at the site of application, no significant increase in the ear thickness and ear punch weights and no effect on body weight. Results from this screening study were used to determine the dosing concentrations of FAT 75637/B for the main LLNA study.
Main LLNA Study
The analyzed radioactivity of ³H-TdR working solution was 77 μCi/mL against the nominal concentration of 80 μCi/mL. There were no clinical signs, no erythema at the site of application and no significant effect on body weight gains. The sensitivity of this LLNA test was demonstrated via the response from the positive control (25 % HCA in 1 % L92), which elicited a stimulation index (SI) of 6.39, in comparison with the vehicle-treated mice. The Mean SI values for 10, 25, and 50 % w/v test item in 1 % L92 were 1.08, 1.22 and 1.50, respectively.
Irritation Screening Test
Body Weights (g) and clinical Signs
Mice Nos. | Dose Concentration | Day 1 (pre-dose) | Day 6 | Body wt. gain (g) | Clinical Signs |
Mh1911 | Vehicle: 1 % L92 | 19.2 | 20.2 | 1.0 | NAD |
Mh1912 | 5 % w/v | 18.9 | 19.9 | 1.0 | NAD |
Mh1913 | 10 % w/v | 19.5 | 20.4 | 0.9 | NAD |
Mh1914 | 20 % w/v | 20.1 | 21.0 | 0.9 | NAD |
Mh1915 | 35 % w/v | 20.0 | 21.0 | 1.0 | NAD |
Mh1916 | 50 % w/v) | 19.8 | 20.7 | 0.9 | NAD |
NAD: No Abnormality Detected
Erythema Scores (for both ears)
Mice Nos. | Dose Concentration
| Day 1 (pre-dose) | Day 2 | Day 3 | Day 6 |
Mh1911 | Vehicle: 1 % L92 | 0 | 0 | 0 | 0 |
Mh1912 | 5 % w/v | 0 | 0 | 0 | 0 |
Mh1913 | 10 % w/v | 0 | 0 | 0 | 0 |
Mh1914 | 20 % w/v | 0 | 0 | 0 | 0 |
Mh1915 | 35 % w/v | 0 | 0 | 0 | 0 |
Mh1916 | 50 % w/v) | 0 | 0 | 0 | 0 |
Erythema scores – 0: No erythema
Ear thickness measurement and ear punch weight
Mice Nos. | Dose Concentration
| Ear thickness (µm) | Ear punch weight (g) | ||||||
Day 1 (pre-dose) | Day 3 | Day 6 | Day 6 | ||||||
L.E | R.E | L.E | R.E | L.E | R.E | L.E | R.E | ||
Mh1911 | Vehicle: 1 % L92 | 249 | 250 | 250 | 251 | 250 | 251 | 0.009 | 0.009 |
Mh1912 | 5 % w/v | 263 | 262 | 264 | 264 | 264 | 264 | 0.010 | 0.010 |
Mh1913 | 10 % w/v | 268 | 269 | 270 | 271 | 270 | 270 | 0.009 | 0.009 |
Mh1914 | 20 % w/v | 257 | 256 | 259 | 258 | 259 | 258 | 0.009 | 0.009 |
Mh1915 | 35 % w/v | 253 | 254 | 255 | 256 | 255 | 255 | 0.010 | 0.009 |
Mh1916 | 50 % w/v) | 260 | 259 | 262 | 261 | 261 | 261 | 0.010 | 0.010 |
1 % L92: 1 % Pluronic L92
L.E: Left ear
R.E: Right ear
TABLE 1 contd. Irritation Screening Test
D. Percent change in ear thickness
Mice Nos. | Dose concentration
| % change in ear thickness | |||
Day 3 | Day 6 | ||||
L.E | R.E | L.E | R.E | ||
Mh1911 | Vehicle: 1 % L92 | 0.40 | 0.40 | 0.40 | 0.40 |
Mh1912 | 5 % w/v | 0.38 | 0.76 | 0.38 | 0.76 |
Mh1913 | 10 % w/v | 0.75 | 0.74 | 0.75 | 0.37 |
Mh1914 | 20 % w/v | 0.78 | 0.78 | 0.78 | 0.78 |
Mh1915 | 35 % w/v | 0.79 | 0.79 | 0.79 | 0.39 |
Mh1916 | 50 % w/v) | 0.77 | 0.77 | 0.38 | 0.77 |
1 % L92: 1 % Pluronic L92
L.E: Left ear
R.E: Right ear
TABLE 2. Summary of Body Weight, Body Weight Changesand Clinical signs
|
|
|
| |||
Group and Dose concentration
| No. of mice |
| Body weight (g) | |||
Day 1 (Initial)
| Day 6 | Weight change (day 6 – Initial) | Clinical signs | |||
G1 Vehicle: 1 % L92 |
6 |
|
|
|
|
|
Mean | 21.267 | 22.367 | 1.100 | NAD | ||
SD | 1.338 | 1.320 | 0.063 | |||
|
|
|
|
| ||
G2 25 % v/v HCA |
6 |
|
|
|
|
|
Mean | 21.233 | 22.167 | 0.933 | NAD | ||
SD | 1.209 | 1.174 | 0.052 | |||
|
|
|
|
| ||
G3 10 % w/v test item |
6 |
|
|
|
|
|
Mean | 21.133 | 22.117 | 0.983 | NAD | ||
SD | 1.029 | 1.026 | 0.041 | |||
|
|
|
|
| ||
G4 25 % w/v test item |
6 |
|
|
|
|
|
Mean | 21.183 | 22.133 | 0.950 | NAD | ||
SD | 0.960 | 0.999 | 0.055 | |||
|
|
|
|
| ||
G5 50 % w/v test item |
6 |
|
|
|
|
|
Mean | 21.150 | 22.083 | 0.933 | NAD | ||
SD | 0.855 | 0.854 | 0.082 | |||
|
|
|
|
|
1 % L92:1 % Pluronic L92
NAD: No Abnormality Detected
HCA: α – Hexylcinnamaldehyde
TABLE 3. Summary of Local Reaction Scores at the Site of Application
Group and Dose concentration
| No. of Mice |
| Erythema Score of both ears (Mean ± SD) | |||
Pre-treatment | Day 2 | Day 3 | Day 6 | |||
G1 Vehicle: 1 % L92 | 6 | Mean SD | 0 0 | 0 0 | 0 0 | 0 0 |
G2 25 % v/v HCA | 6 | Mean SD | 0 0 | 0.83 0.41 | 1.00 0.00 | 1.00 0.00 |
G3 10 % w/v test item | 6 | Mean SD | 0 0 | 0 0 | 0 0 | 0 0 |
G4 25 % w/v test item | 6 | Mean SD | 0 0 | 0 0 | 0 0 | 0 0 |
G5 50 % w/v test item | 6 | Mean SD | 0 0 | 0 0 | 0 0 | 0 0 |
1 % L92: 1 % Pluronic L92
HCA: α – Hexylcinnamaldehyde
Summary of Disintegrations Per Minute (DPM) for ³H-Methyl Thymidine Incorporation in Auricular Lymph Nodes and Stimulation Index (SI)
|
|
| ||
Group and Dose concentration
| No. of mice |
| DPM / Mouse
| SI
|
G1 Vehicle: 1 % L92 | 6 |
|
|
|
Mean | 716.500 | 0.998 | ||
SD | 53.795 | 0.076 | ||
|
|
| ||
G2 25 % v/v HCA | 6 |
| + |
|
Mean | 4575.500 | 6.387 | ||
SD | 841.411 | 1.177 | ||
|
|
| ||
G3 10 % w/v test item | 6 |
| + |
|
Mean | 776.667 | 1.085 | ||
SD | 53.541 | 0.073 | ||
|
|
| ||
G4 25 % w/v test item | 6 |
| + |
|
Mean | 876.833 | 1.225 | ||
SD | 84.353 | 0.118 | ||
|
|
| ||
G5 50 % w/v test item | 6 |
| + |
|
Mean | 1075.667 | 1.502 | ||
SD | 217.467 | 0.306 | ||
|
|
|
+: Significantly higher than the vehicle control group
1 % L92 : 1 % Pluronic L92
HCA: α – Hexylcinnamaldehyde
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A topical application with 10, 25 and 50 % w/v of test item in 1 % Pluronic L92 (1 % L92) elicited a stimulation index (SI) of 1.08, 1.22 and 1.50, respectively. The test item FAT 75637/B did not demonstrate dermal sensitization potential in the mouse LLNA, as the lymph nodes draining the area of topical application did not elicit a proliferative response greater than the 3X threshold.
- Executive summary:
Local Lymph Node Assay (LLNA) was conducted to evaluate the potential of the test item FAT 75637/B to cause contact sensitization by measuring the lymphocyte proliferative response from auricular lymph nodes following topical application to the female CBA/Ca mouse ear. This study was conducted according to OECD test guideline 429 in a GLP-certified laboratory.
Screening Study: Once daily topical application of the vehicle 1 % Pluronic L92 (1 % L92) and 5, 10, 20, 35 and 50 % w/v test item in 1 % L92 were performed on one animal at each dose level. There were no clinical signs, no erythema at the site of application, no significant increase in the ear thickness and ear punch weights and no effect on body weight. The results of this screening test were used to determine the dosing concentration for the main study.
LLNA main study: Six female CBA/Ca mice per group received the vehicle (1 % L92) or 25 % α-hexylcinnamaldehyde (HCA: positive control in 1 % L92) or 10, 25 and 50 % w/v of test item in 1 % L92 on days 1 to 3. On day 6, the uptake of ³H-methyl thymidine into the auricular lymph nodes draining the site of test item application was measured five hours post administration. Proper conduct of the LLNA was confirmed via a positive response using 25 % α-hexylcinnamaldehyde, a contact sensitizer, which elicited proliferation with a Stimulation Index (SI) value of 6.39, in comparison to vehicle-treated mice. There were no clinical signs, no local skin reactions at the tested concentrations and treatment had no significant effect on body weight gain. The test item FAT 75637/B at dose concentrations of 10, 25 and 50 % w/vof test item in 1 % L92 elicited proliferative response with SI of 1.08, 1.22 and 1.50, respectively, in comparison with the vehicle-treated mice. The test item FAT 75637/B did not demonstrate dermal sensitization potential in the mouse LLNA, as the lymph nodes draining the area of topical application did not elicit a proliferative response greater than the 3X threshold.
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