Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
A historical in vivo primary dermal irritation study was conducted on the test substance in the year 2000, prior to in vitro test methods being required.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
An historical in vivo primary dermal irritation study was conducted on the test substance in the year 2000, prior to in vitro test methods being required.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,1,2,3,3-hexafluoro-2-(heptafluoropropoxy)-3-[(trifluorovinyl)oxy]propane
EC Number:
216-703-2
EC Name:
1,1,1,2,3,3-hexafluoro-2-(heptafluoropropoxy)-3-[(trifluorovinyl)oxy]propane
Cas Number:
1644-11-7
Molecular formula:
C8F16O2
IUPAC Name:
1,1,1,2,2,3,3-heptafluoro-3-({1,1,1,2,3,3-hexafluoro-3-[(1,2,2-trifluoroethenyl)oxy]propan-2-yl}oxy)propane
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch: 19B 2059
- Expiration date of the lot/batch: 14 January, 2001
- Purity test date: 14 January, 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Darkness at approximately 20C in a fume cupboard under inert conditions (N2)
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: Test article used neat
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

FORM AS APPLIED IN THE TEST: The test article was applied neat

In vitro test system

Vehicle:
unchanged (no vehicle)
Control samples:
not specified
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

VEHICLE: None
Duration of treatment / exposure:
4 hours
Duration of post-treatment incubation (if applicable):
NA
Number of replicates:
NA

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
SOURCE ANIMAL
- Source: Charles River Deutschland GmbH
- Sex: Female
- Age at study initiation (in days): No data
- Weight at study initiation: 2.3-3.6 kg
- Housing: Individually
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25 C
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 March, 2000 To: 10 March, 2000

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

VEHICLE: None
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 square centimeters
- Type of wrap if used: Semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test article was removed following the 4 hour exposure with warm tap water.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS: 30-60 minutes, 24, 48, and 72 hours.

SCORING SYSTEM:
- Method of calculation: DRAIZE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema or edema was observed in any animal at any observation point.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the test article is not a dermal irritant.
Executive summary:

The primary skin irritation potential of the test article was evaluated in New Zealand albino rabbits. This study was performed in accordance with OECD GLP (1999). The study design was based on OECD 404 (1992) and Directive 92/69/EEC guideline B.4 (1992). The hair was clipped from the dorsal skin of three rabbits exposing an area of approximately 25 square centimeters. The test material (0.5 mL) was applied over the surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was affixed to the prepared area on the intact rabbit skin and covered with a semi-occlusive bandage. At the end of the 4-hour exposure all wrappings were removed and the skin was cleaned of residual test substance using tap water. Observations for skin irritation (erythema and edema) were recorded at approximately 30-60 minutes and 24, 48 and 72 hours after unwrapping. There were no abnormal clinical signs, erythema or edema throughout the study. Based on the results of this study, the test article is not a dermal irritant.