Registration Dossier

Administrative data

Description of key information

Acute toxicity: oral

LD50 > 2000 mg/kg bw in female CRL:(WI) rats.

 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
K1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute Toxicity: oral

Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. The test item was administered formulated in Poly (ethylene glycol) 400 (PEG 400) at a concentration of 200 mg/mL at a dosing volume of 10 mL/kg bw. A single oral treatment was carried out by gavage for each animal after food had been withdrawn overnight. Food was made available again 3 hours after the treatment. Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0 and 7 and Day 14. All animals were subjected to a necropsy and a macroscopic examination.

As no mortality was observed in group 1 a second group (Group 2) of 3 animals was treated at the same dose level using the methods described for group 1.

 

Results

Mortality: BAL0001024 did not cause mortality at a dose level of 2000 mg/kg bw.

Clinical Observations: Clinical signs were observed in all animals treated at the dose level of 2000 mg/kg bw with BAL0001024 and included decreased activity (6/6), hunched back (6/6) and eyelids partially closed (6/6). All symptoms had fully reversed in all animals by the 6 hours and/or Day 1 observation time points.

Body Weight and Body Weight Gain: Two animals at dose level 2000 mg/kg bw (No: 630, 634) showed a reduced body weight gain (0.39 and 2.61 %) in the second week of the observation period. This change was considered incidental and minimal and not ascribed to treatment. There were no treatment related effects on body weight or body weight gain during the observation period.

Macroscopic Findings: There was no evidence of treatment-related macroscopic changes at necropsy in animals given 2000 mg/kg bw.

 

Conclusion: In the absence of any acute toxicity, BAL0001024 can be ranked as "Category 5" or "Unclassified" for acute oral toxicity according to the GHS criteria. Although this study was not designed to determine the acute oral LD50, under the conditions of this study, it is assumed for BAL0001024 to be above 2000 mg/kg bw in female CRL:(WI) rats.

Justification for classification or non-classification

In the absence of any acute toxicity, BAL0001024 can be ranked as "Category 5" or "Unclassified" for acute oral toxicity according to the GHS criteria.