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EC number: 943-080-0 | CAS number: -
Vehicle: cotton seed oil
Test item concentration %
number of lymph nodes
DPM per lymph nodeb)
1 = Control Group
2-4= Test Group
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
No deaths occurred during the study period.
No signs of systemic toxicity were observed during the study period.On days 1 to 4, the animals treated witha test item concentration of10% showed an erythema of the ear skin (Score 1). The animals treated with a test item concentration of 5% showed an erythema of the ear skin on day 3 only. An erythema of the scalp (score: 1) was noted in the animals treated with 5 and 10%, respectively, on day 3 only. Animals treated with 2.5% test item concentration did not show any signs of local skin irritation.
The body weight of the animals, recordedprior to the first application and prior to treatment with3HTdR, was within the range commonly recorded for animals of this strain and age.
Results of the GLP Positive Control
Experiment performed in April 2015 (Harlan study number 1690900). Positive control substance: α-Hexylcinnamaldehyde
Vehicle: acetone:olive oil (4+1, v/v)
a) = The value was taken from the figure BG
Calculation of the EC3 value:
Test Group 3
Test Group 4
EC3 = (a-c) [(3-d)/(b-d)] + c = 10.8% (w/v)
a,b,c,d = Co-ordinates of the two pairs of data lying immediately above and below the S.I. value of 3 on the LLNA dose response plot.
In the study the test item formulated in cotton seed oil was assessed for its possible skin sensitising potential.
For this purpose a local lymph node assay was performed using test item concentrations of 2.5, 5, and 10%. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by two pre-experiments.
The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. On days 1 to 4, the animals treated witha test item concentration of10% showed an erythema of the ear skin (Score 1). The animals treated with a test item concentration of 5% showed an erythema of the ear skin on day 3 only. Furthermore, erythema of the scalp was noted in the animal treated with 5 and 10%, respectively. Animals treated with 2.5% test item concentration did not show any signs of local skin irritation.
In this study Stimulation Indices (S.I.) of 1.36, 0.93 and 2.08 were determined with the test item at concentrations of 2.5, 5, and 10% in cotton seed oil, respectively.
The substance was not a skin sensitiser under the test conditions of this study.
In one LLNA study in mice, in accordance with OECD TG 437, no adverse effects were observed at concentration of 2.5, 5, 10%. Additionally, stimulation indexes were found very low. Substance is not classified for skin sensitisation according to CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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