Registration Dossier
Registration Dossier
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EC number: 406-370-3 | CAS number: 58890-25-8 MDI/CHA
Endpoint summary
Administrative data
Description of key information
The substance was shown to have no sensitisation potential (non-sensitiser) in the Buehler test, as well as in the Local Lymph Node Assay.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a Buehler-Test, performed according to OECD guideline 406 and GLP, an epicutaneous exposure of 25% (w/w) MDI/CHA caused no sensitization reaction to guinea pig skin in the re-challenge phase (sensitization rate of 0%).
The skin sensitisation potential of the substance was also tested in a Local Lymph Node Assay (LLNA) performed in CBA/J@Rj mice according to OECD Guideline 429 and Commission Regulation (EC) B.42. No mortality or systemic clinical signs were observed during the study. No treatment related effect on body weight was observed. Additionally, no irritation or other local effects were observed. Stimulation index values of the test item were 0.5, 0.5 and 0.7 at treatment concentrations of 10 %, 5 % and 2.5 %, respectively. Thus, no significant lymphoproliferative response (SI ≥ 3) was noted. Further, there was no dose-related response. The results of the latest reliability check (performed within an interval of no longer than six months), was used to demonstrate the appropriate performance of the assay in accordance with the OECD guideline 429.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the study results, MDI/CHA does not have to be classified for skin sensitisation according to Regulation (EC) No 1272/2008 and its amendments.
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