Registration Dossier

Administrative data

Description of key information

BAL0001026, 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 object of this study was to determine the skin sensitisation potential of BAL0001026 following dermal exposure in mice. The study was being performed with vertebrate animals as the applied regulatory in vitro alternative tests showed inconclusive/equivocal results. Therefore, an in vivo study was being run to provide reliable information about the skin sensitisation potential of the test item for regulatory acceptance.

 

Based on the results of the Preliminary Compatibility Test, the test item characteristics, its usage and on the recommendations of the OECD Guideline, the best vehicle for the test item was N,N-dimethylformamide (DMF). The 50 % (w/v) formulation was the highest concentration suitable for the test. The 50% (w/v) formulation appeared, by visual examination, to be a suspension and the 25 and 10 % (w/v) formulations appeared to be solutions.

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

-groups (three) of animals received BAL0001026 (formulated in DMF) at either 50, 25 or 10 % (w/v),

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

-a positive control group received 25 % (w/v) HCA (dissolved in DMF). (To minimise 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. Test item precipitation / minimal amount of test item precipitation was observed on the ears in the 50 and 25 % (w/v) treatment groups from Day 1 to Day 5 in all animals. In addition, a minimal amount of test item precipitation was observed on the ears in the 10 % (w/v) treatment group on Day 3 in 3 out of the 4 animals. No marked group mean body weight losses (≥5%) were observed in any groups.

The SI values were 0.6, 0.8 and 0.8 at concentrations of 50, 25 and 10 % (w/v), respectively.

 

In conclusion, under the conditions of the present assay, BAL0001026, 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

BAL0001026, 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.