Registration Dossier
Registration Dossier
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EC number: 480-340-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
not a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitising potential of the substance was assessed in the LLNA test according to the OECD Guideline 429. Groups of five female mice were treated daily for three consecutive days with the test item at concentrations of 10, 25, and 50 % (w/v) by topical application to the dorsum of each ear lobe. A control group was treated with the vehicle only. Five days after the first topical application the mice were injected intravenously with radio-labelled thymidine (3HTdR). Five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. The proliferative capacity of pooled lymph node cells was determined by the incorporation of3HTdR measured in a β- scintilltion counter.
The animals did not show any clinical signs during the course of the study and no cases of local irritation or test item related mortality were observed. One animal of the vehicle control group (animal 1) was found dead on the day of preparation. In this study Stimulation Indices (S.I.) of 1.05, 0.85, and 0.74 were determined with the test item at concentrations of 10, 25, and 50 % respectively. The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. In this study the EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3. The substance is not a skin sensitiser under the tested conditions.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance was assessed for its allergic potential in the in-vivo LLNA study. According to CLP Regulation a substance is classified in sub-category 1 A if the EC3 is ≤ 2 % and in sub-category 1B if the EC3 is > 2. In the present study the EC3 value could not be determined as the Stimulation Index (S.I) in all the tested concentrations was below 3. Having a S.I. below 3 means that no significant effect and neither a sensitising potential can be identified.
Taking in consideration the above, the substance should not be classified as a skin sensitiser according to CLP Regulation.
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