Registration Dossier

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: Comparing to guidelines/standards, basic data is given.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: no data (see comments)
Principles of method if other than guideline:
In this acute oral toxicity study, no details test guideline was presented. However, it is indicated that 10 animals (unspecified sex) per dose and 4 dose levels: 1730 mg/kg, 2470 mg/kg, 3510 mg/kg, and 5000 mg/kg. The results provided were: mortality, time of death of individual animals at different dose levels, signs of toxicity at each dose, and necropsy findings at each dose.
GLP compliance:
not specified
Test type:
other: no data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Aldehyde AA (Triplal)

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Doses:
1730 mg/kg, 2470 mg/kg, 3510 mg/kg, and 5000 mg/kg
No. of animals per sex per dose:
10 anmials per dose and unspecific sex
Control animals:
no
Details on study design:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 900 mg/kg bw
95% CL:
>= 2 900 - <= 5 100
Mortality:
At 1730 mg/kg: 3/10 deaths (2 animals by day 1 and 1 anmial by day 4);
At 2470 mg/kg: 1/10 deaths (by day 1);
At 3510 mg/kg: 3/10 deaths (2 animals by day 1 and 1 animal by day 2).
At 5000 mg/kg: 9/10 deaths (6 animals by day 1, 2 animals by day 2 and 1 animal by day 3)
Clinical signs:
At 1730 mg/kg: diarrhea, lethargy;
At 2470 mg/kg: lethargy, piloerection, diarrhea, ptosis;
At 3510 mg/kg: lethargy, diarrhea, piloerection, comatose;
At 5000 mg/kg: lethargy, piloerection, chromorhinorrhea

Any other information on results incl. tables

Table 1: Necropsy observation

Doses (mg/kg)  1730 2470  3510  5000 
Normal    4  
Cannibalized      1  
Exudate, nose/mouth, red 1    1  
Exudate, nose/mouth, yellow        5
Exudate, nose/mouth, clear     1  
Exudate, nose/mouth, brown   1 1 6
Intestines, areas red 2   10 
Intestines, areas yellow
Intestines, bloated   1 9
Stomach bloated       1
Liver dark 3  
Liver mottled   6 1 1
Lungs, areas dark 3  
Lungs, dark       6
Lungs, fourescent red        1
Kidney dark  4  4
Kidney mottled    
Spleen dark    
Spleen large      2  3
Spleen mottled       
Bladder, blood contained    

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal oral doses (LD50) and their 95% confidence limits to rats of test substance was estimated to be:
LD 50: 3900 mg/kg bw (2900 - 5100 mg/kg bw; 95% C.I)
Executive summary:

In an acute oral toxicity study (1699 02/03), 40 rats (10 per group) were given single oral doses of Ligustral/Cyclal C/Trigustral at 1730, 2470, 3510 and 5000 mg/kg bw and observed after dosing.

Oral LD 50: 3900 mg/kg bw (2900 - 5100 mg/kg bw; 95% C.I)

The following treatment-related effects were noted: clincal signs (lethargy, diarrhea with piloerection, chromorhinorrhea and ptosis noted with higher doses); mortality (at the lowest dosage, 3/10 animals dies; at the highest dosage, only one animal survived during 4 days observation period); necropsy observations (intestines, liver, lungs, kidney and spleen showed abnormalities that appeared dose related. The stomach and bladder showed sporadic abnormalities).