Registration Dossier

Administrative data

Description of key information

No mortality at inhalation exposure concentrations as high as 207 000 ppm (965 153 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:
other: OECD guideline study conducted under GLP
Reference:
Composition 0
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 information:
Composition 1
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

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
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

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:
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an OECD guideline 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 (highest dose tested) for this study.

Justification for classification or non-classification

No lethality or significant toxicity was observed up to 207 000 ppm. No classification is deemed necessary for this endpoint.