Registration Dossier
Registration Dossier
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EC number: 609-462-3 | CAS number: 376653-37-1
Endpoint summary
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.
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