Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Rats were dosed at 1.22, 1.95, 3.12, 5 g/Kg
GLP compliance:
no
Remarks:
Test performed prior to the GLP guideline
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Sample marking: 77-182, Freskomenthe

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
1.22 mg/kg
1.95 mg/kg
3.12 mg/kg
5.00 mg/kg
No. of animals per sex per dose:
10 males per group (per dose)
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 400 mg/kg bw
Based on:
test mat.
95% CL:
ca. 1 900 - ca. 3 000
Remarks on result:
other: 95% confidence limits
Mortality:
1220 mg/kg - 0/10 animals died.
195 mg/kg - 4/10 animals died.
3120 mg/kg - 8/10 animals died.
5000 mg/kg - 10/10 animals died.
Clinical signs:
All doses: lethargy, ataxia, coma, ptosis, piloerection, diarrhea (see details in "Any other information on results" field below)
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Any other information on results incl. tables

Dose: 1.22 g/kg; clinical signs:

 Clinical signs observed included lethargy, ataxia, coma, ptosis, chromorhinorrhea, piloerection, diarrhea and chromodacryorrhea. Necropsy revealed 9/10 animals were normal; red exudate in the nose/mouth in 1/10 animals.

Dose: 3.12 g/kg clinical signs; lethal

8/10 deaths; Deaths occurred on days 1 and 2. Clinical signs observed included coma, prostration, ataxia, chromorhinorrhea, chromodacryorrhea, lethargy, diarrhea and emaciation. Necropsy revealed 2/10 animals were normal; red exudate in the nose/mouth in 8/10 animals; brown anogenital exudate in 3/10 animals; red areas in the intestines in 8/10 animals; yellow areas in the intestines in 8/10 animals; gelatinous intestines in 3/10 animals; bloated intestines in 5/10 animals; yellow fluid in the intestines in 3/10 animals; red areas in the stomach in 5/10 animals; mottled liver in 8/10 animals; dark areas in the lungs in 8/10 animals; mottled kidney in 7/10 animals; white nodule on the outer surface of the kidney in 1/10 animals; dark spleen in 3/10 animals; mottled spleen in 5/10 animals; creamy yellow fluid in stomach in 2/10 animals.

Dose: 1.95 g/kg clinical signs; lethal

4/10 deaths; Deaths occurred on days 2 and 12. Clinical signs observed included coma, prostration, ataxia, chromorhinorrhea, diarrhea, chromodacryorrhea, ptosis and emaciation. Necropsy revealed 3/10 animals were normal; 1/10 animals cannibalized; red exudate in the nose/mouth in 3/10 animals; yellow exudate in the nose/mouth in 2/10 animals; brown anogenital exudate in 3/10 animals; red areas in the intestines in 3/10 animals; yellow areas in the intestines in 3/10 animals; gelatinous intestines in 3/10 animals; orange fluid in the stomach in 2/10 animals; yellow fluid in the stomach in 1/10 animals; mottled liver in 3/10 animals; dark lungs in 3/10 animals; dark kidney in 4/10 animals; mottled kidney in 1/10 animals; mottled spleen in 3/10 animals; bladder-blood contained in urine in 1/10 animals.

Dose: 5 g/kg clinical signs; lethal

10/10 deaths. Deaths occurred on days 1 and 2. Clinical signs observed included coma, ataxia, lethargy, ptosis and chromorhinorrhea. Necropsy revealed red exudate in the nose/mouth in 2/10 animals; brown anogenital exudate in 1/10 animals; red areas in the intestines in 5/10 animals; yellow areas in the intestines in 10/10 animals; bloated intestines in 7/10 animals; red areas in the stomach in 9/10 animals; stomach, area approximately 10% bubbled out and thin in 4/10 animals; dark liver in 1/10 animals; mottled liver in 8/10 animals; dark liver in 3/10 animals; dark areas in the lungs in 7/10 animals; mottled kidney in 5/10 animals; pale kidney in 2/10 animals; mottled spleen in 5/10 animals; creamy yellow fluid in the stomach in 7/10 animals.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
In conclusion the LD50 has been detrmined to be LD50(rat)= 2400 mg/kg bw (1900-3000 mg/kg bw).
Freskomenthe meets the criteria to be classified Category 5 according to the GHS classification.
Executive summary:

LD50 has been detrmined to be LD50(rat)= 2400 mg/kg bw (1900-3000 mg/kg bw).

Freskomenthe meets the criteria to be classified Category 5  according to the GHS classification.