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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
471-480-0
EC Name:
-
Cas Number:
1645-83-6
Molecular formula:
Hill formula: C3H2F4 CAS formula: C3H2F4
IUPAC Name:
(1E)-1,3,3,3-tetrafluoroprop-1-ene

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Kingston, New York
- Age at study initiation: Approximately 10 weeks
- Weight at study initiation: Males 320 - 368 g; females 211- 262 g
- Fasting period before study:
- Housing: individually in suspended stainless steel cages during study
- Diet: ad libitum
- Water : ad libitum
- Acclimation period:approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 to 22.1
- Humidity (%): 42.16 to 56.35
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Method of holding animals in test chamber: nose only exposure chambers
- Source and rate of air: 5 litres/min
- Temperature, humidity, pressure in air chamber: 16 to 20 °C, humidity 35 to 60 %


TEST ATMOSPHERE
- Brief description of analytical method used: total carbon analyser
- Samples taken from breathing zone: yes


Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Remarks on duration:
5 minutes added for t99
Concentrations:
103300 ppm (481378 mg/m3) and 207000 ppm (964620 mg/m3)
No. of animals per sex per dose:
5
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,organ weights
Statistics:
None - all animals survived the exposures

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 207 000 ppm
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: no lethality at highest concentration tested equivalent to 964620 mg/m3
Mortality:
No mortality observed
Clinical signs:
other: No clinical signs of toxicity observed
Body weight:
No effects on body weight observed
Gross pathology:
No gross pathology observed

Any other information on results incl. tables

No mortality, no clinical signs of toxicity, no treatment-related changes to body weight, and no food consumption changes were observed. At termination, gross necropsy observations were normal and there were no treatment-related or statistically significant differences in organ weights (kidneys, liver and lungs) or organ weight ratios.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality was observed so the 4 hour LC50 value of vapour fo HFO-1234ze was higher than 207000 ppm for both sexes. In addition, immediately after exposure at this high level, signs of narcosis were not seen.