1,1,1,2,3,3-hexafluoro-2-[1,1,2,3,3,3-hexafluoro-2-[1,1,2,3,3,3-hexafluoro-2-[1,1,2,3,3,3-hexafluoro-2-(1,1,2,2,3,3,3-heptafluoropropoxy)propoxy]propoxy]propoxy]-3-(1,2,2,2-tetrafluoroethoxy)propane

Acute Toxicity: oral

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

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 or test system 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:

other: hunched posture and/or piloerection in all animals on Day 1

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.