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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2008
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:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: The acute inhalation toxicity of MTDID 7908 was evaluated in male Sprague Dawley rats following a 30 minute or 4 hour exposure. The study design followed a custom protocol. Male rats (3/group) were whole body exposed to the vaporized test material at concentrations of 800 or 2400 ppm for 30 minutes; 280 and 850 ppm as 4-hour equivalents, respectively.
- Parameters analysed / observed: Clinical signs were noted during exposure and daily thereafter. Gross necropsy was conducted following a 14 day observation period.
GLP compliance:
no
Test type:
other: Custom protocol
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Perfluoropropionyl fluoride
EC Number:
207-019-5
EC Name:
Perfluoropropionyl fluoride
Cas Number:
422-61-7
Molecular formula:
C3F6O
IUPAC Name:
pentafluoropropanoyl fluoride
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 9
- Expiration date of the lot/batch: No data
- Purity test date: 13 July, 2008

FORM AS APPLIED IN THE TEST: The liquid test article was heated to form a vapor.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan
- Females (if applicable) nulliparous and non-pregnant: NA
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: Group houses in standard solid-bottom cages
- Diet (e.g. ad libitum): Harlan Teklad Rat/Mouse 2018 Diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 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: 14 July, 2008 To: 30 July 2008

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 40 liter test chamber
- Exposure chamber volume: 40 liters
- Method of holding animals in test chamber: None, whole body exposure
- Source and rate of air: No data
- Method of conditioning air: No data

TEST ATMOSPHERE
- Brief description of analytical method used: No data
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 30 - ca. 240 min
Remarks on duration:
Two exposures were conducted, one for 30 minutes and the other for 4 hours.
Concentrations:
Male rats (3/group) were whole body exposed to the vaporized test material at concentrations of 800 or 2400 ppm for 30 minutes; 280 and 850 ppm as 4-hour equivalents, respectively. Additional male rats (3/group) were whole body exposed to the vaporized test material at concentrations of 100 or 300 ppm for 4 hours.
No. of animals per sex per dose:
3 males per group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
> 300 ppm
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occurred during the study.
Clinical signs:
other: Irregular respiration rate, lethargy and labored breathing were noted in animals exposed for 30 minutes at 800 or 2400 ppm.  No other abnormal clinical signs were noted in any groups throughout the study.  
Body weight:
No abnormal body weight changes were identified during the study.
Gross pathology:
There were no abnormal pathological findings upon necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: The classification cannot be determined from this study alone. See endpoint summary for weight of evidence conclusion.
Remarks:
The classification cannot be determined from this study alone. See endpoint summary for weight of evidence conclusion.
Conclusions:
 The 4-hour inhalation LC50 for MTDID 7908 is considered to be greater than 300 ppm in rats.
Executive summary:

The acute inhalation toxicity of MTDID 7908 (a gas) was evaluated in male Sprague Dawley rats following a 30 minute or 4 hour exposure. The study design followed a custom protocol.  Male rats (3/group) were whole body exposed to the test material at concentrations of 800 or 2400 ppm for 30 minutes; 280 and 850 ppm as 4-hour equivalents, respectively.  Additional male rats (3/group) were whole body exposed to the test material at concentrations of 100 or 300 ppm for 4 hours.  The rats were terminated at 14 days post-exposure.  Parameters evaluated: clinical observations, body weights, food consumption, and macroscopy.  Irregular respiration rate, lethargy and labored breathing were noted during exposure in animals exposed for 30 minutes at 800 or 2400 ppm; animals appeared normal after exposure termination.  No other abnormal clinical signs, body weight changes, food consumption changes or macroscopic observations were noted in any groups throughout the study.  The 4-hour inhalation LC50 for MTDID 7908 is considered to be greater than 300 ppm in rats.

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