Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals

Species:
rat
Strain:
other: Tif. RAI rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 160 to 180 g
-Fasting: one night before starting the treatment
- Housing: segregated and housed in Macrolon cages (Type 3)
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 50

Administration / exposure

Route of administration:
other: oral intubation
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
Concentration % of formulation: 30 %
Doses:
- 4640, 6000 and 7750 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
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: sedation, dyspnoea, curved position and ruffled fur

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 750 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was seen throughout the course of the study.
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. All animals had recovered within 7 to 8 days.
Gross pathology:
No substance-related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of FAT 40061/A in rats of both sexes, observed over a period of 14 days is greater than 7750 mg/kg bw.
Executive summary:

The test was performed to determine the acute oral toxicity of FAT 40061/A using a method equivalent or similar to OECD Guideline 401 (Acute Oral Toxicity). Three groups of rats, each containing 5 males and 5 females, were administered the test item at 4640, 6000 and 7750 mg/kg bw. The rats used were of 6 -7 weeks of age and weighing 160 to 180 g. No animals died during the experiment. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. All animals had recovered within 7 to 8 days. No substance related gross organ changes were seen at the autopsy. In conclusion, the acute oral LD50 of FAT 40061/A in rats of both sexes, observed over a period of 14 days is greater than 7750 mg/kg bw.