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:
other: Basic data given, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

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
Principles of method if other than guideline:
None
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 (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 1 C
- 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 mg/kg
- 6000 mg/kg
- 7750 mg/kg
No higher doses were possible.
No. of animals per sex per dose:
15 males and 15 females per dose.
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
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 700 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
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.
Body weight:
No data
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of FAT 40061/A in rats of both sexes, observed over a period of 14 days is greater than 7700 mg/kg.
Executive summary:

The test was performed to determine the acute oral toxicity of FAT 40061/A according to the equivalent or similar OECD guideline 401 (Acute Oral Toxicity). It was tested on 30 Tif. RAI rats which were 6 to 7 weeks old and weighed about 160 to 180 g.

FAT 40061/A was tested at different doses: 4640 mg/kg, 6000 mg/kg and 7750 mg/kg.

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. They were killed and autopsied after an observation period of 14 days which did not execute any gross organ changes. No animals died during the experiment.

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 7700 mg/kg.