Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 December 1995 to 26 December 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD Guideline-conform study conducted under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1150 (Acute inhalation toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

EC Number:

500-537-5

EC Name:

Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Cas Number:

161075-00-9

Molecular formula:

R-O(C3F6O)m-R with R= - CF3, - C2F5, -CF2H

IUPAC Name:

1,1,1,2,3,3-hexafluoro-2,3-bis(1,1,2,2,2-pentafluoroethoxy)propane; 1,1,1,2,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)-3-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)-2-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-{[1,1,1,2,3,3-hexafluoro-3-(trifluoromethoxy)propan-2-yl]oxy}-2-(trifluoromethoxy)propane; 1,1,1,3,3,4,6,6,7,9,9,10,12,12,12-pentadecafluoro-4,7,10-tris(trifluoromethyl)-2,5,8,11-tetraoxadodecane; 1-(difluoromethoxy)-1,1,2,3,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)propane; 2,2,3,5,5,6-hexafluoro-3,6-bis(trifluoromethyl)-1,4-dioxane; 2-(difluoromethoxy)-1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)propane

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): GALDEN HT 70
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: >99%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 3217RE
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: Room temperarture, in the original container.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: livestock farming
- Age at study initiation: about 8 weeks
- Weight at study initiation: males: 320-337 g, females: 216-246 g
- Fasting period before study: not reported
- Housing: 5 rat of same sex/cage. Cage size: 35cm x 53 cm x 25 cm, suspended on a movable rack.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the day of exposure

ENVIRONMENTAL CONDITIONS
- Temperature (°C): within the limit of 12°C - 22°C
- Humidity (%): betwen 36% and 53%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hour cicle (8 a.m.-8 p.m.)

IN-LIFE DATES: From: To: not reported

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
- System of atmosphere generation: The test atmosphere was generated by vaporising GALDEN LMW in a stream of air flowing through a heated coppel coil (vaporiser) immersed in a water bath. The test substance was delivered to the vaporiser at a constant flow rate from a stainless steel reservoir by a metering pump. The air supplied to the vaporiser was dried, filtered and oil free.

- Exposure apparatus: The test atmosphere entered through a port at the top of the chamber and passed out through a port in the base of the chamber.
- Exposure chamber volume: approximately 70 litres

- Description of exposure chambers: The whole-body exposure chambers used for the exposures were of square section and were fitted with pyramidal tops. The chambers were made of acrylic polymer. Each chamber was divided by wire mesh partitions to provide 10 separate animal compartements. Each chamber was positioned inside a large cabinet equipped with an extract fan exhausting to atmosphere through a collection filter.
The rats to be exposed were placed into separate compartments of the exposure chambers.

- Temperature in air chamber: 24 °C +- 0.6 (Test group), 23 °C +- 0.4 (Control group);
- Oxygen concentration in air chamber: 20% +- 0.2 (Test group), 20% +- 0.1 (Control group);

TEST ATMOSPHERE
- Brief description of analytical method used: Analysis was carried out by gas chromatography and standardised by using preparations of the test substance vapour in gas bags. (Pye Unicam PU4550 Gas Chromatograph fitted with gas injection valve; Detector: Flame Ionisation)
- Samples taken from breathing zone: Yes. Six air samples were taken from the chamber during the exposure. The air samples, obtained using a polypropylene syringe, were directed straight to the Gas Chromatograph.

VEHICLE
- Composition of vehicle (if applicable): air.
- Concentration of test material in vehicle (if applicable): 9.47 % (v/v) +- 0.623
- Lot/batch no. (if required): n.a.
- Purity: n.a.

PROCEDURE
The test material was pumped from the reservoir, mixed with a supply of clean dried air and passed through the vapour generator. The flow rate of test material was 14ml/minute and the air supply pressure was adjusted to give a flow rate of 14 litres per minute through the generator.
The pump and air supplies were switched on and the exposure time for 4 hours, following a 12-minute equilibration period (12 minutes is the theoretical time required for the concentration of vapour in the chamber to reach 90% of its final value under the conditions of exposure employed).
The control group was treated similarly but exposed to clean air only for 4 hours. The control rats were returned to the holding room at the end of the exposure procedure.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

9.47 % (v/v) +- 0.623 (target concentration : 10% v/v)

No. of animals per sex per dose:

10 (5 males + 5 females)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the rats were observed continuously for signs of reaction to the test substance during exposure and at least twice daily throughout the observation period. The clinical signs were recorded at the end of the chamber equilibration period, at 0.25, 0.5 and 1.0 hours and then at hourly intervals during the exposure. During the observation period the clinical signs were recorded once in the morning and then as necessary following a later check for clinical signs.
All rats were weighed daily from the day of delivery to the testing laboratory until the end of the observation period.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, lung weights, gross pathology.

Results and discussion

Preliminary study:

Not performed.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 94 700 ppm

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: analytical mean value

Remarks:

ppm (v/v)

Mortality:

There were no deaths in the group of rats exposed to the test material.

Clinical signs:

other: There were no clinical signs during the exposure or following exposure to the test material.

Body weight:

There were no effect on the rate of bodyweight gain for rats exposed to the test material.

Gross pathology:

There were no macroscopic abnormalities in test and control rats.

Other findings:

The lung weight to bodyweight ratio was within normal limit for all rats.

Any other information on results incl. tables

Food and water consumption was not affected by exposure to the test material.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute inhalation LC50 (4-hour) of GALDEN LMW to rats was in excess of 9.47% (v/v) in air.
Based on MW range 350-500 this is equivalent to 1355-1936 mg/L.

Executive summary:

The objective of this study was to establish the acute inhalation toxicity of Galden LMW to rats.

The study design was in compliance with the OECD guideline Method No. 403 and EEC guideline Method B2.

One group of five male and five female Sprague Dawley CD rats was exposed to an atmosphere containing 9.47% (v/v) of GALDEN LMW. Exposure was continuous for 4 hours using a whole body exposure system. An additional group of 5 males and 5 females acted as controls and were exposed to air only for 4 hours.

Animals were observed during the exposure period and for 14 days post exposure. Group food and water consumption were measured daily throughout. Each animal was subjected to post mortem examination.

There were no deaths following exposure to GALDEN LMW.

No clinical signs were observed during and after exposure.

Bodyweight gain for the rats exposed to GALDEN LMW was similar to that of the control rats.

Food and water consumption were no affected following exposure to GALDEN LMW.

Lung weight to bodyweight ratios for the rats exposed to GALDEN LMW were within normal limits.

There were no macroscopic abnormalities in rats exposed to GALDEN LMW.

In conclusion the acute inhalation LC50 (4-hour) of GALDEN LMW to rats was in excess of 9.47% (v/v) in air (corresponding to 1355 - 1936 mg/L).