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EC number: 811-207-8 | CAS number: 1497420-94-6
Very slight erythema was noted for the animals treated at 100% on Days 2 and 3. No irritation was observed on the animals treated at 50% and no signs of systemic toxicity were observed in any of the animals examined. Variations in ear thickness during the observation period were less than 25% from Day 1 pre-dose values for all animals.
Based on these results, the highest test substance concentration selected for the main study was a 100% concentration.
Clinical Observations, Bodyweight and Mortality Data – Preliminary Screening Test
0= No signs of systemic toxic
Local Skin Irritation – Preliminary Screening Test
Local Skin Irritation
Measurement of Ear Thicknessand Mean Ear Thickness Changes – Preliminary Screening Test
Ear Thickness Measurement (mm)
overall mean (mm)
overall meanear thickness change (%)
na= Not applicable
Individual Disintegrations per Minute and Stimulation Indices
Mean dpm/Animal(Standard Deviation)
Vehicleacetone/olive oil 4:1
Test Item25% v/vinacetone/olive oil 4:1
Test Item50% v/vinacetone/olive oil 4:1
Positive Control Item
25% v/v inacetone/olive oil4:1
dpm=Disintegrations per minute
N/A= Not applicable
a= Total number of lymph nodes per animal is 2
b= Stimulation Index of 3.0 or greater indicates a positive result
Summary of Positive Control Data for the Local Lymph Node Assay
α‑Hexylcinnamaldehyde, technical grade
Acetone/Olive oil (4:1 v/v)
α‑Hexylcinnamaldehyde, technical grade
a= Ratio of test to control lymphocyte proliferation
b= Stimulation index greater than 3.0 indicates a positive result
Individual Clinical Observations and Mortality Data
Vehicleacetone/olive oil 4:1Å
0= No signs of systemic toxicity
Calculation of EC3Value
These results show that the test substance elicits a SI ≥ 3. Although, the data do not permit the use of linear interpolation, calculation of EC3 values (the estimated test substance concentration that will give a SI =3) by loglinear extrapolation can provide a reliable estimation of sensitization potency class for use in risk assessment and can avoid the need for repeat animal testing. The data show a clear doseresponse and a slope ratio of 0.38 was calculated indicating that extrapolation can provide a reliable estimation of the EC3 value according to Ryan et al 2007. An estimated EC3 value of 23.9% was calculated.
Individual Bodyweights and Bodyweight Changes
Bodyweight Change (g)
Clinical Observations and Mortality Data
No irritation of the ears was observed in any of the animals examined. No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. The majority of auricular lymph nodes were considered normal in size, except for the nodes of one animal at 100% which were considered enlarged. No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
The skin sensitisation potential of FRET 09 -0035 has been tested according to OECD TG 429: Local Lymph Node Assay" method and GLP principles. At 25, 50 and 100% the substance showed SI values of 1.8, 2.2 and 4.1, respectively. The majority of auricular lymph nodes were considered normal in size, except for the nodes of one animal at 100% which were considered enlarged. These results show that the test substance elicits a SI ≥ 3 and an estimated EC3 value of 71.1% was calculated. The test item was considered to be a sensitiser and should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction. A NOAEL of 12500 µg/cm2 is derived.
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