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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
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in compliance with OECD GLP (1999) regulations.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Perfluorpropylvinylether
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 98.1%
- Purity test date: 14 January, 2000
- Lot/batch No.: 10B1001
- Expiration date of the lot/batch: 14 January 2001
- Stability under test conditions: No data
- Storage condition of test material: Under darkness at approximately 20 C in a fume cupboard under inert conditions (N2)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation:
- Weight at study initiation: 2.6-3.0 kg
- Housing: Separately
- Diet (e.g. ad libitum): Ssniff K-H (V2333), ad libitum and hay (approximately 15 g daily).
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 C
- Humidity (%): 30-70 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14 March, 2000 To: 17 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:
The test article was left on the skin for 4 hours.
Observation period:
Examinations took place after 30-60 minutes as well as 24, 48, and 72 hours after patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: a 2.5 x 2.5 cm area on the dorsal region of each rabbit
- Type of wrap if used: The test article was admistered over a cellulose patch on a piece of surgical plaster that was fixed with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure area was washed with warm tap water.
- Time after start of exposure: 4 hours.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: All erythema scores were 0 for all animals at all time points.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: All edema scores were 0 for all animals at all time points.
Irritant / corrosive response data:
No signs of irritation were observed during the study. All erythema and edema scores were 0 at 24, 48 and 72 hours in all animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test article is not irritating to skin.
Executive summary:

The primary dermal irritation potential of the test article was determined in New Zealand White rabbits. The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD 404 (1992). The test article (0.5 mL) was administered unchanged to clipped skin on a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster on the dorsal region of each rabbit. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The test article was left on the skin for a 4 hour exposure. After the exposure period, all remnants of the test article were carefully removed from the skin by washing with warm tap water. Examinations of the skin took place after 30 -60 minutes as well as 24, 48, and 72 hours after patch removal. Erythema, eschar formation and edema were evaluated and scored according to the Draize scale. No signs of irritation were observed during the study. All erythema and edema scores were 0 at 24, 48 and 72 hours in all animals. Based on the results of the study, the test article is not irritating to skin.