Registration Dossier

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:
other: OECD study conducted under GLP. The dosing volume was limited to 0.4 ml due to the volatility of the test substance.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
0.4 ml test substance
GLP compliance:
yes
Remarks:
US laboratory, no certificate available

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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/1 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
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
0
Reversibility:
other: no irritation observed so no reversibility noted
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
HFO-1234ze is not irritating to rabbit skin following 60 sec, 3 minute, or 4 hours of exposure.