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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:
27 Nov 2001 to 30 Nov 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in accordance with good laboratory practice (GLP) regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

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
Reference substance name:
Perfluormethoxypropylvinylether
IUPAC Name:
Perfluormethoxypropylvinylether
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Perfluormethoxypropylvinylether
- Substance type: Clear colorless liquid
- Physical state: Liquid
- Analytical purity: 98%
- Purity test date: 30 Jul 2000
- Lot/batch no.: Lot 3
- Expiration date of the lot/batch: 31 Dec 2002
- Storage condition of test material: Darkness at approximately 5 °C in a refrigerator under nitrogen atmosphere

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Sex: Female
- Age at study initiation: Not reported
- Weight at study initiation: 2.7-3.8 kg
- Fasting period before study: None
- Housing: Single animal per cage
- 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): 17-23
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27 Nov 2001 To: 30 Nov 2001

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hour exposure to the test article
Observation period:
72 hours
Number of animals:
3 females were exposed
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Substance was adminstered ona piece of surgical plaster which was fixed to the area and covered with a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remnants of the test substance were removed from the skin with warm tap water.
- Time after start of exposure: 4 hours after beginning the exposure.
SCORING SYSTEM: Erythema and edema was scored according to the DRAIZE method.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours.
Score:
ca. 0
Reversibility:
fully reversible
Remarks on result:
other: Scale 4. No erythema or edema was observed in any animal at any observation time during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
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 dermal irritation potential of the test article was evaluated in New Zealand White rabbits (3 female). The study was conducted according to OECD GLP (1999). The test method was based on OECD 404 (1992), EEC Method B.4. (1992) and US EPA OPPTS 870.2500 (1998). Prior to exposure (24 hours) the hair on the left flank of each animal (25 mm2) was clipped. Each animal was treated with 0.5 mL of the test article dosed on a 2.5 cm2 cellulose patch, placed on a piece of surgical plaster and covered with a semi-occlusive bandage. The patch was left in place for 4 hours, after which the remaining test article was removed from the exposure site with warm water. The skin was examined for erythema and edema at 1, 24, 48, and 72 hours. Animals were observed daily for clinical signs and mortality. No abnormal clinical signs were observed in any animals during the study period. No erythema or edema was observed in any animal at any time period during the study. Based on the results of the study, the test article is not irritating to skin.