Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 April 2010 - 10 July 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions and OECD Guideline 423

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTDID 21721, TFEE-5
- Substance type: clear colorless liquid
- Physical state: liquid
- Lot/batch no.: TFEE5-276/12/09-1
- Expiration date of the lot/batch: 12 Dec 2012
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark under nitrogen

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: approximately 8 weeks
- Weight at study initiation: 143 - 165 g
- Fasting period before study: overnight
- Housing: Macrolon cages, 3 animals per cage, sterilized sawdust bedding, paper as cage enrichment
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3.0
- Humidity (%): 40-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 13 Apr 2010 To: 29 Apr 2010

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.23 ml/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs daily; body weight on days 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: LD50 > 2000 mg/kg bw
Mortality:
none
Clinical signs:
hunched posture and/or piloerection in all animals on Day 1
Body weight:
normal
Gross pathology:
no abnormalities noted

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
rat oral LD50 > 2000 mg/kg bw
Executive summary:

OBJECTIVE: The acute oral toxicity of TFEE-5 (MTDID 21721, batch TFEE5-276/12/09-1) was evaluated in female Wistar rats.

METHODS: This study was performed in compliance with OECD GLP (1997). The study design was based on OECD 423 (2001), EC 440/2008, B1, USEPA OPPTS 870.1100 (2002) and JMAFF guidelines (2000) including the most recent partial versions. TFEE-5 was tested as received. Two groups (3 females each) received 2000 mg/kg TFEE-5 via oral gavage. The rats were observed immediately and at 2 and 4 hours postdose and then once daily for 14 days. Body weights were recorded pretest, weekly, and at termination. All animals were examined for gross pathology.

RESULTS: All animals survived. Hunched posture and/or piloerection were noted in all animals on Day 1. There were no abnormal body weight changes or necropsy findings in any animals.

CONCLUSION: Based on the results of this study, the acute oral LD50 of TFEE-5 in female rats was greater than 2000 mg/kg.