Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tragacanth (0.5%)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 11.2; 13.6; 15; 16.5; 18.1 mg/L
- Amount of vehicle (if gavage): 2.15 ml/kg
- Justification for choice of vehicle: test substance not soluble in water


Doses:
0.024-0.038 mL/kg corresponding to 24.1-39.0 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
Probit analysis

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
33.7 mg/kg bw
95% CL:
31.1 - 36.5
Sex:
male
Dose descriptor:
LD50
Effect level:
31.6 mg/kg bw
95% CL:
28.6 - 34.8
Sex:
male/female
Dose descriptor:
LD50
Effect level:
32.7 mg/kg bw
95% CL:
30.8 - 34.4
Mortality:
Mortality (if any) was observed within 30 min after administration
males: 24.5 mg/kg bw: 0/5
29.6 mg/kg bw: 1/5
35.7 mg/kg bw: 4/5
38.8 mg/kg bw: 5/5

females: 29.6 mg/kg bw: 0/5
32.6 mg/kg bw: 2/5
35.7 mg/kg bw: 3/5
38.8 mg/kg bw: 5/5
Clinical signs:
clonic (and tonic) convulsions, tremor, decrease of  muscle tone, general loss of reflexes, dyspnea, redness of the skin in females. Symptoms appeared 2 min after administration and persisited in surviving animals 1 to 6 h.
Body weight:
no data
Gross pathology:
Only red decoloration of mucosa of the gastrointestinal tracts observed in some animals. No other changes were found.

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Remarks:
Migrated information