Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity (OECD TG 423 Acute Toxic Class Method; GLP): LD50 > 2000 mg/kg bw (BASF SE 2021; 10A0281/20X062).
Key value for chemical safety assessment
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 oral toxicity
In the chosen key study for acute oral toxicity according to OECD TG 423 (Acute Toxic Class Method) and GLP (BASF SE 2021; 10A0281/20X062), a dose of 2000 mg/kg bw of the undiluted test item Santalol oil was administered by gavage to two test groups of three fasted Wistar rats each (6 females). The following test substance-related clinical observations were recorded, clinical signs occurred within the first 3 hours after administration:
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 one animal
- Piloerection in one animal
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 the observation period (6 females). The acute oral LD50 was assessed to be > 2000 mg/kg bw in rats.
Justification for classification or non-classification
The present data on acute oral toxicity do not fulfill the criteria laid down in regulation (EU) 1272/2008, and therefore, a non-classification is warranted. According to UN-GHS, the test substance does not need to be classified as acute oral toxicant.
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