Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Key study: Read-across approach from experimental data on the analogue substance MPKO:

A skin sensitization study was performed using the method of Ritz & Buehler and according with OECD Guideline 406 (GLP study). Based on the experimental data on the analogue substance MPKO, the hydrolysis product of OS3600 (non-sensitizer since after the challenge, erythema was absent to faint in the induced group and absent in the naive control group), the substance OS3600 was also determined to be non-sensitizer.

Key study: Read-across approach from experimental data on the analogue substance MPKO:

A Local Lymph Node Assay was performed with MPKO in accordance with OECD Guideline 429 (GLP study). Based on the experimental data on the analogue substance MPKO, hydrolysis product of OS3600 (non-sensitizer since the SI values calculated for concentrations 25, 50 and 100% were 1.5, 1.1 and 1.3 respectively (SI < 3)), the substance OS3600 was also considered to be non-sensitising to the skin.


Migrated from Short description of key information:
Based on the read-across approach from the analogue substance MPKO, OS3600 was determined to be non-sensitizer to the skin in both guinea pig (Buehler) and LLNA studies.

Justification for selection of skin sensitisation endpoint:
No study has been selected since both studies (Buehler and LLNA tests) are negative.

Justification for classification or non-classification

Based on the available experimental results, the substance OS3600 is not classified for skin sensitization in accordance with CLP Regulation (EC) no. 1272/2008.