Registration Dossier

Diss Factsheets

Administrative data

Description of key information

LD50 acute oral in the rat is > 2000 mg/kg bw 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: test procedure meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
original language: German
GLP compliance:
Test type:
other: following old standard method
Details on test animals or test system and environmental conditions:
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 7-9 weeks
- Weight at study initiation: mean males 172 g, mean females 161 g
- Fasting period before study: approximately 16 hours
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
Route of administration:
oral: gavage
other: water and cremophor
1000, 1500, 1750, 2000, 2500, 3000, 3500, and 5000 mg/kg bw
No. of animals per sex per dose:
10 males/dose
Control animals:
Details on study design:
- Duration of observation period following administration: 21 days
- Observation for clinical signs and mortality, feces
- Frequency of weighing: before administration, after one week and et the end of the 14-day observation period
Probit-Analysis (Fink and Hund, Arzneimittelforschung 15, 624, 1965)
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Probit-Analysis revealed an LD50 of 2057 mg/kg
1000 mg/kg: 0/10
1500 mg/kg: 2/10
1750 mg/kg: 4/10
2000 mg/kg: 5/10
2500 mg/kg: 6/10
3000 mg/kg: 9/10
3500 mg/kg: 9/10
5000 mg/kg: 10/10
Clinical signs:
general bad condition
Body weight:
reduced at 3500 and 5000 mg/kg bw
Other findings:
brown-red feces, increased water consumption and elimination
LD50 was calculated to be greater than 2000 mg/kg bw
Executive summary:

The acute oral toxicity of the test item was evaluated in a study on male Wistar rats. Single oral doses of 1000 to 5000 mg/kg bw were given to groups of 10 male rats. Mortality occurred at doses of 1500 mg/kg bw and above. The LD50 of the test item was calculated with 2057 mg/kg bw and thus is > 2000 mg/kg bw. According to EU Regulation 1272/2008 no classification for acute oral toxicity is warranted.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Additional information

Justification for classification or non-classification

The acute oral LD50 of the test item in rats is determined with > 2000 mg/kg bw. According to EU Regulation 1272/2008 no classification for acute oral toxicity is warranted.