Registration Dossier

Administrative data

Description of key information

Acute Oral  toxicity study in male and female Wistar rats 
Testing facility: RCC Ltd, Switzerland
Study no. 842956 performed on July 29,2002
Acute Dermal toxicity study in male and female Wistar rats
Testing facility: RCC Ltd, Switzerland
Study no. 842957 performed on May 6, 2002.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
The study was conducted under GLP, in accordance with OECD no.423 "Acute oral Toxicity - Acute Toxic Class Method" and Annex IVB, Part B.1 tris (Acute toxicity oral - Acute Toxic Class Method) to Directive 67/548/EEC..

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The study was conducted under GLP in accordance with OECD no.402 "Acute dermal Toxicity" and Directive 92/69/EEC, B.3 "Acute toxicity dermal, July 31, 1992.

Additional information

A group of six fasted Wistar rats (3 males and 3 females) received a single oral gavage dose of 2000 mg/kg bw. The test item was diluted in PEG 300 at a concentration of 0.2 g/ml and administered at a volume dosage of 10 ml/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at app. 1,2,3,5 hrs after treatment on day 1 and once daily during test days 2 -15. Mortality/viability was recorded twice daily during test days 1 -15 .

All animals survived until the end of the study period. No clinical signs were observed during the course of the study.No macroscopic findings were recorded.

One group of five male and five female HanBrl: Wist (SPF) rats was treated by dermal application at 2000 mg/kg. The test item was diluted in PEG 300 at a concentration of 0.5 g/ml and administered at a volume dosage of 4 ml/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at app. 1,2,3,5 hrs after treatment on day 1 and once daily during test days 2 -15. Mortality/viability was recorded twice daily during test days 1 -15 .

No deaths occurred during the study. No clinical signs were observed during the course of the study.

No macroscopic findings were recorded.


Justification for selection of acute toxicity – oral endpoint
One available study

Justification for selection of acute toxicity – dermal endpoint
One available study

Justification for classification or non-classification

The LD50 of FEBA 1 after single oral administration to rats of both sexes, observed over a period of 14 days is > 2000 mg/kg b.w.

The LD50 of FEBA 1 after single dermal administration to rats of both sexes, observed over a period of 14 days is > 2000 mg/kg b.w.

Based on the study, the test substance is to be regarded as relatively non toxic and not to be classified.