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EC number: 203-458-1
CAS number: 107-06-2
The potential of the test item,
1,2-dichloroethane, to induce delayed contact hypersensitivity, was
the murine Local Lymph Node Assay (LLNA).
Evaluation of local irritation was also carried out in parallel.
A preliminary test was first performed
in order to define the concentrations of test item to be used in the
In the main test, twenty female CBA/J
mice were allocated to five groups:
treated groups of four animals receiving the test item at the
concentration of 25, 50 or 100% in a mixture acetone/olive oil (4/1;
negative control group of four animals receiving the vehicle,
positive control group of four animals receiving the reference item, a-hexylcinnamaldehyde
(HCA), a moderate sensitizer, at the concentration of 25% in the vehicle.
During the induction phase, the test
item, vehicle or reference item was applied over the ears (25 µL per
ear) for 3 consecutive days (days 1, 2 and 3). After 2 days of resting,
the proliferation of lymphocytes in the lymph node draining the
application site was measured by incorporation of tritiated methyl
thymidine (day 6). The obtained values were used to calculate
Stimulation Indices (SI).
The irritant potential of the test
item was assessed in parallel by measurement of ear thickness on days 1,
2, 3 and 6.
The test item was soluble in the first
recommended vehicle, acetone/olive oil (4/1, v/v).A solution was
obtained at the maximum tested concentration of 50%.
Consequently, the concentrations
selected for the preliminary test were 10, 25, 50 and 100%.
Since the test item was non-irritant
in the preliminary test, the highest concentration retained for the main
test was the maximal practicable concentration (100%).
Neither mortality nor clinical signs
were observed during the study.
No cutaneous reactions and no notable
increase in ear thickness were observed in the animals of the treated
A significant lymphoproliferation was
noted in the positive control group given HCA at 25%. The study was
therefore considered valid.
No notable lymphoproliferation was
noted at any tested concentration.
The results are presented in the
Under the experimental conditions of
this study, the test item, 1,2-dichloroethane, (batch No. R1104 du
17/02/2010), did not induce delayed contact hypersensitivity in the
murine Local Lymph Node Assay.
The potential of EDC to induce delayed contact hypersensitivity, was evaluated in the murine Local Lymph Node Assay (LLNA, OECD 429) (Rokh, 2010). This study is a well-conducted LLNA according to OECD guideline and under GLP. Since EDC was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximal practicable concentration (100%). In the main test, neither mortality nor clinical signs were observed. No cutaneous reactions and no notable increase in ear thickness were observed in the animals of the treated groups. The SI (Stimulation Index) were 0.46, 0.86 and 2.16 for the following EDC concentrations: 25 %, 50 % and 100%. Therefore, ethylene dichloride was not a sensitiser in the LLNA.
EU directive 67/548/EEC and EU Regulation (EC) N0. 1272/2008 (CLP), the
substance is not classified for skin sensitisation.
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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