(1E)-1,3,3,3-tetrafluoroprop-1-ene

Acute Toxicity: inhalation

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: OECD guideline study conducted under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report Date:

2004

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Remarks:

US laboratory, no certificate available

Test type:

standard acute method

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals 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 - 368g; females 211-262g
- 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°C
- 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
- Exposure chamber volume:
- Method of holding animals in test chamber: nose only exposure chambers
- Source and rate of air: 5 liters/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 analyzer
- 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:

103,300 and 207,000 ppm

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

Sex:

male/female

Dose descriptor:

LC0

Effect level:

> 207 000 ppm

Exp. duration:

4 h

Remarks on result:

other: no lethality at highest concentration tested

Mortality:

No mortality observed

Clinical signs:

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:

practically nontoxic

Remarks:

Migrated information expert judgement

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.