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Diss Factsheets

Administrative data

Description of key information

HFO-1234ze did not cause skin irritation in rabbit skin following 60 sec, 3 minutes, or 4 hours of exposure.  No dedicated studies are available for the evaluation of the eye irritating potential of HFO-1234ze. However, acute exposure up to 270000 ppm and repeated inhalation exposure up to 15000 ppm HFO-123ze did not show signs of eye, skin or respiratory irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The dosing volume was limited to 0.4 mL due to the volatility of the test substance.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc (Denver, CO)
- Age at study initiation:
- Weight at study initiation: 2.7 - 2.9 kg
- Housing:individually in suspended cages with paper bedding beneath the cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature controlled
- Humidity controlled
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 mL
Duration of treatment / exposure:
60 sec, 3 minutes, 4 hours
Observation period:
72 hours post exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 mm (Hill top chamber)
- Type of wrap if used: porous dressing large enough to cover the dose site with at least 5 cm square on all sides. Wrap kept in place with non-irritating tape encircling the animal

REMOVAL OF TEST SUBSTANCE
- Washing : not needed

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
HFO-1234ze was not irritating to rabbit skin
Other effects:
No other effects observed
Interpretation of results:
GHS criteria not met
Conclusions:
HFO-1234ze is not irritating to rabbit skin following 60 sec, 3 minute, or 4 hours of exposure.
Executive summary:

In a skin irritation study performed in accordance with GLP and OECD guideline 404 three New Zealand White rabbits were exposed semi-occlusive to the test substance. The test substance was found not to be irritating to rabbit skin following 60 sec, 3 minute, or 4 hours of exposure.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No skin irritation was observed in rabbit skin following 60 sec, 3 minute or 4 hour dermal exposure to HFO-1234ze. Therefore classification and labelling for irritation/corrosion is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments.