Registration Dossier

Administrative data

Description of key information

BAL0001024, tested in DMF, did not show any sensitisation potential (non-sensitizer) 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:

The aim of this study was to determine the skin sensitisation potential of BAL0001024 following dermal exposure in mice.

A Preliminary Irritation/Toxicity Test was performed in CBA/CaOlaHsd mice using four doses (2 animals/dose): 100, 50, 25 and 10 % (w/v) in DMF and based on the results, 25 % (w/v) was selected as top dose for the main test.

In the main assay, twenty female CBA/CaOlaHsd mice were allocated to five groups, each group comprised four animals:

-groups (three) of animals received BAL0001024 (formulated in DMF) at either 25, 10 or 5 % (w/v),

-a negative control group received the vehicle (DMF) only,

-a positive control group received 25 % (w/v) HCA (dissolved in DMF). (To minimize animal use, the positive control was part of a parallel study (17/219-037E)

 

There was no mortality or signs of systemic toxicity observed during the study. A minimal amount of test item precipitate was observed on the ears of the 25 % (w/v) dose group animals from Day 2 up to Day 3 (4 out of the 4 animals).

No marked group mean body weight losses (≥5%) were observed in any groups. 

The SI values were 0.7, 1.1 and 1.0 at concentrations of 25, 10 and 5 % (w/v), respectively.

 

In conclusion, under the conditions of the present assay, BAL0001024, tested in DMF, did not show any sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

BAL0001024, tested in DMF, did not show any sensitisation potential (non-sensitizer) in the Local Lymph Node Assay. 

No classification/labelling is triggered according to Regulation (EC) No 1272/2008 (CLP) / GHS (rev. 7) 2017.