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Administrative data

Description of key information

Based on the data  it can be concluded that the test substance FAT 40061 is not toxic by oral route. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
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
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 %
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
Preliminary study:
None
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

None

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
7 700 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A Key study was conducted to assess the acute oral toxicity of the test substance in Wistar rats according to OECD Guideline 401.

No mortality occurred and no significant macroscopic abnormalities were seen at necropsy. Under the study conditions, the oral LD50 of the test substance was found to be > 7700 mg/kg bw in rats.

Analysis of our substance does not indicate any harm upon oral exposure and neither the chemical structure of the substance nor any toxicokinetic results raise any concern about the toxic behavior of the substance upon dermal absorption, we will not perform any test on this endpoint in in vitro or in vivo test systems.


Justification for selection of acute toxicity – oral endpoint
Detailed study conducted as per guideline.

Justification for classification or non-classification

Based on the above stated assessment of the acute oral toxicity the substance does not need to be classified for Acute Oral toxicity according to CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.