1,1,2,2,3,3-hexafluoro-1,3-bis[(trifluorovinyl)oxy]propane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was not conducted in compliance with GLP regulations but was well documented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Custom protocol

Principles of method if other than guideline:

Male rats (3/group) were exposed, whole body, to MTDID 34177 at 92.2 ppm (1.30 mg/L, vapor) or 899.5 ppm (12.66 mg/L, vapor) for a single, 1 hour exposure. Control animals were not utilized. Clinical observations (during and post exposure, daily thereafter) and body weights (Days 1, 8, and 15) were recorded. Limited necropsy was performed on all surviving animals on Day 15 post dose.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

MTDID 34177

IUPAC Name:

MTDID 34177

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): MTDID 34177
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 98.8%
- Purity test date: 01 October, 2012
- Lot/batch No.: No data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 170-191 grams
- Fasting period before study: No data
- Housing: Group housed in standard solid-bottom plastic cages with bedding
- Diet (e.g. ad libitum): Harlan Teklad Rat/Mouse 2018 Diet (Harlan Teklad, Madison, WI) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6-23.9
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16 January 2013 To: 30 January 2013

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 40-liter plexiglass chamber
- Exposure chamber volume: 40 liter
- Method of holding animals in test chamber: None: whole body exposure

TEST ATMOSPHERE
- Brief description of analytical method used: Gas chromatographic-electron caputre detector (GC-ECD) method.
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 1 h

Concentrations:

92.2 ppm (1.30 mg/L, vapor) and 899.5 ppm (12.66 mg/L, vapor)

No. of animals per sex per dose:

3 males/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made through out exposure and daily thereafter. Body weights were recorded on Days 1, 8, and 15.
- Necropsy of survivors performed: yes, limited gross necropsy.
- Other examinations performed: clinical signs, body weights

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

> 6.33 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

1

Remarks on result:

other: 4 hour equivalent LC50 calucalted from 1 hr exposure at 12.66 mg/L with no deaths or adverse clinical signs.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No abnormal clinical signs were observed.

Body weight:

All animals in both groups gained weight during the study.

Gross pathology:

No gross lesions or significant findings were noted in any animal upon necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Low dose tested not suitable for classification

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on the results of the study, the 1-hour LC50 of the test article was >899.5 ppm (12.66 mg/L, vapor) and the 4-hour equivalent LC50 is > 6.33 mg/L, vapor.

Executive summary:

 The acute inhalation toxicity of the test article (Colorless liquid, Purity 98.8%, Lot: DVE-3-AH194-ANL0033902) was evaluated in Sprague Dawley rats. The study was not conducted under GLP conditions. The test method was based on a custom protocol. Male rats (3/group) were exposed, whole body, to the test article at 92.2 ppm (1.30 mg/L, vapor) or 899.5 ppm (12.66 mg/L, vapor) for a single, 1 hour exposure. Control animals were not utilized. Clinical observations (during and post exposure, daily thereafter) and body weights (Days 1, 8, and 15) were recorded. Limited necropsy was performed on all surviving animals on Day 15 post dose. All animals in both groups survived to scheduled necropsy. No abnormal clinical signs were observed in any animal during the study period. All animals in both groups gained weight during the study. No gross lesions or significant findings were noted in any animal upon necropsy. Based on the results of the study, the 1-hour LC50 of the test article was >899.5 ppm (12.66 mg/L, vapor) and the 4-hour equivalent LC50 is > 6.33 mg/L, vapor.