Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1980-03-06 to 1980-05-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study similar to OECD TG 401 (Acute Oral Toxicity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: 8 weeks old
- Weight at study initiation: 165-198 g
- Fasting period before study: 16-20 h prior to dosing
- Housing: 5/cage in suspended wire mesh cages
- Diet (e.g. ad libitum): Fresh Purina rat chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 1980-03-06 To: 1980-03-20

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 5.4 mL/kg
Doses:
5.0 g/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 3-4 hours after dosing and once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
The LD50 was calculated according to the method of Litchfield JTJ & Wilcoxon F, JPET 96-99, 1949.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the observation period of 14 days.
Clinical signs:
Isolated instances of diarrhea , chromorhinorrhea and emaciation were noted during the early part of the study. All animals were normal on days 6 through 13. One instance of chromorhinorrhea was noted on day 14.
Gross pathology:
All animals, sacrificed on day 14, were normal.

Applicant's summary and conclusion

Interpretation of results:
other: EU CLP criteria
Remarks:
not classified
Conclusions:
The substance was acutely not toxic to rats in an acute oral toxicity test with an LD50 value of 5000 mg/kg bw. No classification according to CLP is required.
Executive summary:

Ten healthy male Wistar rats with initial body weights between 165-198 grams were treated with 5000 mg/kg bw test substance orally. The animals were fasted prior to dosing. Clinical observations for mortality and/or systemic effects were made daily up to 14 days post dosing. Isolated instances of diarrhea, chromorhinorrhea and emaciation were noted during early part of the study. All animals survived up to end of study and were sacrificed on day 14. No effects were observed at gross necropsy. The LD50 was > 5000 mg/kg bw.