Registration Dossier
Registration Dossier
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EC number: 609-463-9 | CAS number: 376653-41-7
Endpoint summary
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.
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.
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