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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The study was performed to assess the skin sensitization potential of JNJ-31052047-ABI using the local lymph node assay (LLNA).

Preliminary investigations were performed at 10 and 25% w/v JNJ-31052047-ABI in dimethylsulphoxide with 2 female mice per concentration to establish the highest concentration of test substance which did not lead to systemic toxicity or excessive

local irritation.

The study comprised three treated groups, each comprising four female mice receiving JNJ-31052047-ABI at concentrations of 5, 10 or 25% w/v in dimethylsulphoxide. Similarly constituted groups received the vehicle (dimethylsulphoxide) or positive control substance (25% v/v hexyl cinnamic aldehyde). The mice were treated by daily application of 25 µl of the appropriate concentration or control (vehicle or positive), to the dorsal surface of both ears for three consecutive days.

The proliferative response of the lymph node cells (LNC) from the draining auricular lymph nodes was assessed five days following the initial application, by measurement of the incorporation of 3H-methyl thymidine (3HTdR) by beta-scintillation counting of

LNC suspensions. The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio), termed as Stimulation Index (SI).

The results of preliminary investigations indicated that 25% w/v was the highest feasible concentration for use on the main study. The SI obtained for 5, 10 and 25% w/v were 1.9, 4.6 and 8.4 respectively which indicated that JNJ-31052047-ABI showed the potential to induce skin sensitization. The EC3 value was calculated to be 7% w/v. The SI for the positive control substance hexyl cinnamic aldehyde was 3.9, which demonstrated the validity of this study.

JNJ-31052047-ABI is regarded as a potential skin sensitizer. The EC3 value was calculated to be 7% w/v.

Migrated from Short description of key information:
In a LLNA test according to OECD Guideline 429 and EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay) , the test item was observed to be sensitising to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study results and the criteria of the DSD and CLP Regulation, JNJ-31052047 -ABI should be classified as skin sensitising substance R43 and category 1B (H317).