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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study reported within the assessment for National Industrial Chemicals Notification according to the Industrial Chemicals (Notifiation and Assessment) Act 1989 (an Act of the Commonwealth of Australia) and performed according to OECD Guideline 403.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FM200
- Molecular formula (if other than submission substance): not reported
- Molecular weight (if other than submission substance): not reported
- Smiles notation (if other than submission substance): not reported
- Substance type: halogenated hydrocarbon
- Physical state: gaseous
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Lot/batch No.: CN-1742
- Stability under test conditions: Yes
- Storage condition of test material: stored in gas cylinders at room temperature

Test animals

Species:
rat
Strain:
other: Crl:CD/BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Inc, Portage Michigan, US
- Age at study initiation: young adult
- Weight at study initiation: 236-298 grams
- Fasting period before study: not reported
- Housing: individual suspended wire mesh cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-70 °F
- Humidity (%): 54-72%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: From: 17/07/1991 To: 31/07/1991

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
The acute whole body inhalation toxicity of HFC-227ea was assessed in 10 Crl:CD/BR rats (5/sex/dose) at an exposure level of 788696 ppm. The test material was administered continuously in oxygen to the test chamber for 4 hours. Animals were monitored for a 14 day period post exposure and terminally necropsied.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Atmosphere samples were collected through a valve port located on the front of the exposure chamber with a disposable 10 ml B-D syringe. The sample was then injected into a gas chromatograph.
Duration of exposure:
4 h
Concentrations:
788,696 ppm
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Statistics:
not performed

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 788 696 ppm
Based on:
test mat.
Remarks:
measured concentration
Exp. duration:
4 h
Mortality:
No deaths occurred during the study.
Clinical signs:
All animals showed signs of anaesthesia during the study (including decreased motor activity, decreased respiration, ataxia and prostration).
Lacrimation was observed in one animal and tail chewing in another.
Body weight:
During the observation period, a decrease in mean body weight (1.4%) was observed in female animals, while males exhibited a reduction in mean body weight gain.
Gross pathology:
There were no significant lung weight differences in any of the animals during the course of the study. Necropsy revealed red foci in the lung of one animal, and a mottled lung in another.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU