Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
One animal was inadvertently dosed at 1875 mg/kg body weight.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTDID 7145
- Physical state: Liquid
- Analytical purity :~ 94.5%
- Lot/batch no.: 142072.43
- Expiration date of the lot/batch:30 December 2007
- Stability under test conditions: Stable
- Storage condition of test material: At room termperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 9 weeks old
- Weight at study initiation: 165-192 grams
- Fasting period before study: yes,(overnight)
- Housing:- Diet (e.g. ad libitum): adlibitum
- Water (e.g. ad libitum):adlibitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 deg C
- Humidity (%): 47-92%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: To: August to September 2006

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Neat
- Amount of vehicle (if gavage): 1.111 ml/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: Day 1, 8 and 15
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: There were no abnormalities in remaining clinical observations, body weight and macroscopic post mortem examination.
Mortality:
none
Clinical signs:
There were no abnormalities clinical observations. Unched posture and piloerection were observed on day 1 after dose administration, only
Body weight:
no abnormalities
Gross pathology:
There were no abnormalities in the macroscopic post mortem examination.

Applicant's summary and conclusion

Interpretation of results:
Category 1 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The oral LD50 of FC-770 in Wistar rats was >2000 mg/kg body weight.
Executive summary:

The acute oral toxicity of FC-770 (liquid, batch 142072-43) was assessed in female 9 week old Wistar rats following OECD guideline No. 423 (2001), “Acute Toxicity-Oral, Acute Toxic Class Method.” Five animals were given a single undiluted oral gavage dose of 2000 mg/kg body weight. One additional animal was inadvertently dosed at 1875 mg/kg body weight. The results from this inadvertent dose were consistent with the 2000 mg/kg dose group and for the purposes of this study that animal was considered as receiving the 2000 mg/kg dose. Animals were observed daily for 15 days. Body weights were recorded on day 1, 8 and 15. A necropsy was performed on day 15. Hunched posture and piloerection were observed on day 1 after dose administration. There were no abnormalities in remaining clinical observations, body weight and macroscopic post mortem examination. The oral LD50 of FC-770 in Wistar rats was >2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Based on these results FC-770 does not have to be classified and has no obligatory labeling requirement for oral toxicity according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations and EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).