Registration Dossier

Diss Factsheets

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
Value:
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 A single oral treatment was carried out by gavage for each animal after food had been withdrawn overnight.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: BAL0001022 did not cause mortality at a dose level of 2000 mg/kg bw.

Clinical Observations: Treatment with BAL0001022 at the dose level of 2000 mg/kg bw did not cause any adverse clinical signs.

Body Weight and Body Weight Gain: There was no relevant treatment related effects on body weight or body weight gain during the observation period. One animal given 2000 mg/kg bw (No: 627) showed a reduced body weight gain (0.39%) in the second week of the observation period. This change was considered incidental and not ascribed to treatment.

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

 

Conclusion:Although this study was not designed to determine the acute oral LD50, under the conditions of this study, it is assumed for BAL0001022 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, BAL0001022 can be ranked as "Category 5" or "Unclassified" for acute oral toxicity according to the GHS criteria.