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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
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

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:
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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.