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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No mortality at inhalation exposure concentrations as high as 207000 ppm (964620 mg/m3)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

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

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
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

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.

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
> 207 000 ppm air
Physical form:
inhalation: gas
Quality of whole database:
GLP compliant OECD TG 403 study

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a GLP compliant OECD TG 403 study, 10 Sprague Dawley rats (5 males and 5 females) were exposed to 100000 or 207000 ppm HFO-1234ze in atmosphere for 4 hours. No mortality or other signs of toxicity were observed within 14 days after the exposure. The lowest lethal dose (LDLo) was > 207000 ppm (964620 mg/m3) (highest dose tested) for this study.

Justification for classification or non-classification

Based on the information on the acute oral, acute dermal and acute Inhalation toxicity study classification for acute toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.