1-Propene, 1,3,3,3-tetrafluoro-

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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.