Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study report, basic information given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1958
Report Date:
1958

Materials and methods

Principles of method if other than guideline:
The approximative dose (ALD50) was determined according to the methods of Behrens (cited in J.H. Burn: Bthol. Standardization, 1937).
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further data

Test animals

Species:
rat
Strain:
other: "normal"
Sex:
female
Details on test animals and environmental conditions:
The mean body weights of the rats was 135.8 g.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous emulsion with 1% Traganth
Doses:
2.0, 7.9, 15.9, 20.4, 25.1, 31.6, 40, 63, 316 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
ca. 25 mg/kg bw
Mortality:
All high-dosed animals died after 48 hours. No deaths were observewd in the three low dose groups (for details see table below).
Clinical signs:
The animals showed no remarkable symptoms before application.
The toxic symptoms were unspecific. The animals were apathetic and atonic after the application, breathing was accelerated and frequently intermittent.
Body weight:
no remarkable changes
Gross pathology:
The lethal contaminated animals died not acutely, but within 1 - 4 days. The surviving animals were killed after 14 days and necropsied. No pathological changes were observed macroscopically at the organs.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg)  Mortality after        untreated control
   24 hours  48 hours  7 hours  
 316  3/5  5/5  5/5  
 63 (first dosage)  3/5  5/5  5/5  
 63 (second dosage)  0/5  0/5  1/5  
 40 (first dosage)  0/5  1/5  2/5  
 40 (second dosage)  5/5  5/5  5/5  12/12
 31.6  0/5  4/5  4/5  7/8
 25.1  0/5  0/5  1/5  3/8
 20.4  0/5  1/5  2/5  2/10
 15.9  0/5  0/5  0/5  
 7.9  0/5  0/5  0/5  
 2.0  0/5  0/5  0/5  

Applicant's summary and conclusion

Interpretation of results:
highly toxic
Remarks:
Migrated information