2,3,3,4,4-pentafluoro-5-methoxy-2,5-bis[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]tetrahydrofuran

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Principles of method if other than guideline:

- Principle of test: Repeated-dose inhalation toxicity.
- Short description of test conditions: The test method was based on a custom protocol. Rats (3 males) were exposed, whole body, to 100 ppm (vapor) of the test article for 6 hours per day for 5 consecutive days. Control rats (3 males) were treated in a similar manner with the exclusion of exposure to the test material.
- Parameters analysed / observed: Clinical observation were recorded continuously during each exposure period. Body weights were recorded for all animals each day prior to exposure. Animals were euthanized immediately following Day 5 exposure and gross necropsy, liver tissue collection, serum collection and body weight measurements were performed.

GLP compliance:

no

Test type:

other: Screening study.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,3,3,4,4-pentafluoro-2,5-bis(1,1,1,2,3,3,3-heptafluoropropan-2-yl)-5-methoxyoxolane

EC Number:

812-244-2

Cas Number:

957209-18-6

Molecular formula:

C11H3F19O2

IUPAC Name:

2,3,3,4,4-pentafluoro-2,5-bis(1,1,1,2,3,3,3-heptafluoropropan-2-yl)-5-methoxyoxolane

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, NB#159571-76, Purity: 99.9%
- Expiration date of the lot/batch: Not specified
- Purity test date: 17 February, 2012

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was unchanged.

FORM AS APPLIED IN THE TEST: A vapor of the test article was generated.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 170-178 g
- Fasting period before study: None
- Housing: All rats were group housed in solid bottom cages after each daily exposure.
- Diet (e.g. ad libitum): Harlan Tedland 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: 12 March, 2012 To: 16 March, 2012

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
Vapor was generated by adding a calculated amount of the test article to a test chamber of known volume containing the animals. The atmosphere was supplemented with oxygen if necessary to maintain a level of at least 18%. No other parameters specified in the study report.

TEST ATMOSPHERE
- Brief description of analytical method used: Not specified.
- Samples taken from breathing zone: Not specified

VEHICLE: Air

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

ca. 6 h

Concentrations:

0 (control), 100 ppm

No. of animals per sex per dose:

3 males per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: Animals were dosed for 6 hours a day for 5 days and necropsied following the final exposure.
- Frequency of observations and weighing: Observations were made continually during exposures and body weights were recorded daily prior to exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, liver weights were recorded, serum samples collected for clinical chemistry analysis.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LC0

Effect level:

100 ppm

Based on:

test mat.

Exp. duration:

6 h

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No treatment-related clinical signs were observed during the study.

Body weight:

There was no statistically significant difference in average group body weight gain.

Gross pathology:

No macroscopic abnormalities were observed in any of the treated animals at necropsy.

Other findings:

Clinical chemistry: A statistically significant increase in calcium was noted in treated rats compared to controls.
Liver weights: Liver weights were similar between treated and control animals.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Based on the results of the study, the 6 hour, 5-day inhalation LD50 value of the test article is greater than 100 ppm (2.16 mg/L, vapor).

Executive summary:

The acute inhalation toxicity of the test article was evaluated in a 5-day repeat inhalation toxicity test in Sprague-Dawley rats. Rats (3 males) were exposed, whole body, to 100 ppm (vapor) of test article for 6 hours per day for 5 consecutive days. Control rats (3 males) were treated in a similar manner with the exclusion of exposure to the test material. Rats were weighed daily and were euthanized immediately following the Day 5 exposure. Animals were subject to a gross necropsy, livers collected and weighed, and serum samples collected for clinical chemistry evaluation. All animals survived the 5-day exposure period and showed no clinical signs of toxicity or macroscopic abnormalities at necropsy. The test article treated rats showed statistically significant increases in calcium blood serum levels as compared to the controls (p<0.05); however, it should be noted that both the control and exposed groups serum calcium values were above those recognized as the normal range for Wistar rats. Liver weights and body weights were in normal ranges and similar for all animals. Based on the results of the study, the 6 hour, 5-day inhalation LC50 value of the test article is greater than 100 ppm (2.16 mg/L, vapor).