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:

A reliable Local lymph node assay was performed on J-37 accoriding to OECD Guideline 429 ((NOTOX, 2010). Three experimental groups of five females CBA/J mice were treated with test substance concentration of 5, 10 or 25% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (Acetone/Olive(4:1 v/v)). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurement was performed.

Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 10, and 25% were 417, 713 and 361 DPM respectively. The mean DPM/animal value for the vehicle control group was 509 DPM. The SI values calculated for the substance concentrations 5, 10 and 25% were 0.8, 1.4 and 0.7 respectively. Since there was no indication that the test substance could elicit an SI 3 when tested up to 25%, it was established that the EC3 value (the estimated test substance concentration that will give a SI=3) (if any) exceeds 25%.


Migrated from Short description of key information:
A key skin sensitisation study (LLNA) on J-37 showed no sensitisation potential to human skin.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
This information is not available.

Justification for classification or non-classification

According to DSD and CLP classification criteria for skin sensitisation, no classification is required for J-37.