[No public or meaningful name is available]

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Principles of method if other than guideline:

- Principle of test: Acute inhalation screening study.
- Short description of test conditions: Two groups of male Sprague Dawley rats (3/group) were exposed to the test article at a target vapor concentration of 200 and 1000 ppm in a static, whole-body, inhalation exposure chamber for 1 hour and then evaluated for 14 days.
- Parameters analysed / observed: Clinical observations, body weights and limited necropsy.

GLP compliance:

no

Remarks:

This study was not conducted in compliance with GLP but was deemed acceptable for hazard communication.

Test type:

traditional method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5-hexafluoro-5-iodopent-1-ene

Cas Number:

1601491-27-3

Molecular formula:

C5H3F6I

IUPAC Name:

3,3,4,4,5,5-hexafluoro-5-iodopent-1-ene

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 160034-77
- Purity, including information on contaminants, isomers, etc.: 94.1%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the dark at room temperature.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The test article was warmed on the way to the exposure chamber to aid in vapor formation.

FORM AS APPLIED IN THE TEST (if different from that of starting material) : Dosed neat.

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
- Females (if applicable) nulliparous and non-pregnant:
- Rationale for use of males (if applicable)
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 186-200 g
- Fasting period before study: None
- Housing: Group housed in solid bottom cages with bedding.
- Historical data: Maintained by the lab.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days.
- Microbiological status when known : No data
- Method of randomisation in assigning animals to test and control groups: No data

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: 30 April 2012 To: 14 May 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
- Exposure apparatus: 40 liter plexiglass chamber
- Exposure chamber volume: 40 liters
- Method of holding animals in test chamber: None
- Source and rate of air (airflow):
- Method of conditioning air: Test article was introduced into and air samples were withdrawn from the recirculating airstream via separate septum fittings in the copper tubing. The tubing passed through warm water baths just upstream and downstream from the sample injection port to help volitalize the test article. Chamber tempreature, humidity, oxygen concentration and test article concentration were monitored during the exposures.

TEST ATMOSPHERE
- Brief description of analytical method and equipment used: HP 6890 GC.
- Samples taken from breathing zone: No
- Time needed for equilibrium of exposure concentration before animal exposure : No data

VEHICLE : None

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 1 h

Concentrations:

Target concentrations were 200 and 1000 ppm. Analytically verified concentrations were 227.4 and 1113.5 ppm (2.5 mg/L and 12.4 mg/L, vapor).

No. of animals per sex per dose:

3 males per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed during and at the end of the exposure periods, approximately 2 hours following exposure, and at least once daily thereafter during the 14-day observation period.
- Necropsy of survivors performed: Yes, limited
- Clinical signs including body weight : Animals were weighed on day 1, 8 and 15. Animals were observed daily for clinical signs.
- Other examinations performed: clinical signs, body weights, gross necropsy.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

> 6.9 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: See 'Remarks'

Remarks:

4-hour equivalent exposure calculated from the 1-hour exposure data.

Mortality:

No mortality was observed during the study.

Clinical signs:

other: See 'Remarks'

Remarks:

'Hyperactivity and agitation' were observed during the exposure period in the 1000 ppm group. No clinical signs were observed in either dose group after exposure.

Body weight:

All animals gained weight during the study.

Gross pathology:

Upon necropsy, one animal in the 200 ppm group and one animal in the 1000 ppm group had slightly mottled lungs. The two remaining animals at 1000 ppm had slightly red and mottled lungs.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of the study, the 1-hour LC50 of the test article was > 13.8 mg/L (1113 ppm). The equivalent 4-hour LC50 is > 6.9 mg/L.

Executive summary:

The acute inhalation toxicity of the test article was evaluated in Sprague Dawley rats. The study was intended for screening purposes and was therefore not performed in full compliance with GLP guidelines. The test method was similar to OECD No 403 (1981). The test article was administered as a vapor. Rats (3 male/group) were exposed, whole body, to the test article at 200 or 1000 (equivalent doses are 2.5 mg/L and 12.4 mg/L respectively) for a single 1 hour exposure. Actual measured concentrations were 222.74 +/- 14.1 ppm and 1113.5 +/-53.2 ppm (equivalent doses are 2.8 mg/L and 13.8 mg/L respectively). Clinical observations were made during and at the end of exposure, approximately 2 hours following exposure and at least once daily until Day 14. Animals were weighed on Day 1, 8, and 15. Limited necropsies were performed on all animals at termination.   All animals in both exposure groups survived until scheduled termination. Hyperactivity and agitation were observed in the 1000 ppm exposure group during exposure. No clinical signs were observed after exposure. All animals gained weight during the study. At necropsy, one animal at 200 ppm and one animal at 1000 ppm had slightly mottled lungs. The two remaining animals at 1000 ppm had slightly red and mottled lungs.  Under the conditions of the study, the 1-hour LC50 for the test article was > 13.8 mg/L (1113 ppm). The equivalent 4-hour LC50 is > 6.9 mg/L.