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.

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

 

Results

Mortality: BAL0001026 did not cause mortality at a dose level of 2000 mg/kg bw.

Clinical Observations: Treatment with BAL0001026 at the dose level of 2000 mg/kg bw did not cause any adverse clinical signs. 

Body Weight and Body Weight Gain: 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, BAL0001026 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 BAL0001026 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, BAL0001026 can be ranked as "Category 5" or "Unclassified" for acute oral toxicity according to the GHS criteria.