Registration Dossier
Registration Dossier
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EC number: 701-295-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on a GLP compliant acute toxic class study (OECD 423) in female rats the median lethal dose (LD50) of the test substance after oral administration was found to be greater than 2000 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
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
In an acute oral toxicity study performed according to the Acute Toxic Class Method, doses of 2000 and 300 mg/kg bw of the test item (undiluted or preparations in corn oil Ph.Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females and 300 mg/kg bw in 3 females).
The following test substance-related clinical observations were recorded, clinical signs occurred within the first 4 hours after administration:
Experiments were conducted with 3 test groups (1st and 2nd test group for 2000 mg/kg bw, 3rd test group 300 mg/kg bw)
2000 mg/kg (first test group):
- No mortality occurred
- No clinical signs were observed
2000 mg/kg (second test group):
- No mortality occurred
- Impaired general state in all animals
- Dyspnoea in all animals
- Piloerection in all animals
- Cowering position in all animals
300 mg/kg (single test group):
- No mortality occurred
- No clinical signs were observed
All animals gained weight in a normal range throughout the study period.
There were no macroscopic pathological findings in any animal sacrificed at the end of observation period (9 females).
The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.
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