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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:
07-DEC-1999 to 18-JAN-2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This GLP-compliant study was conducted in accordance with OECD guideline 404 and EU method B.4.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Substance type: monoconstituent 
- Physical state: colourless liquid
- Analytical purity: 100%
- Density: 1.64
- Lot/batch No.: 6-99
- Manufacturing date: 24 May 1999
- Expiration date of the lot/batch: May 2001
- Storage condition of test material: at room temperature
Specific details on test material used for the study:
- Name of test material (as cited in study report): Perfluorosulfonyl vinyl-ether
- Purity: 100%
- Impurities, purity test date: no data available
- Physical state: colourless liquid
- Lot/batch No.: 6-99
- Manufacturing date: 24 May 1999
- Expiration date of the lot/batch: May 2001
- Storage condition of test material: at room temperature, away from humidity

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Conelli S.n.c. / Via Milano, 61 - 28041 ARONA (Novara) / ITALY
- Age at study initiation: 2-3 months old when received
- Weight at study initiation: 2.5-2.8 kg when received; on arrival at RBM, all animals were clinically observed and 20% of them were weighed: their weight conformed to that required.
- Housing: in the same room in which the treatment was performed; in metal cages with stainless steel feeders
- Diet: ad libitum with a diet coded "2 RB 15 GLP Certificate" (Charles River Italia's feed licensee Mucedola S.r.l., Settimo Milanese) supplemented by the producer with vitamins and trace elements
- Water: ad libitum, filtered water from municipal water main system
- Acclimation period: from 14-JUL-1999 to 07-DEC-1999

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2°C
- Humidity: 55 ± 10%
- Air changes: about 15-20 per hour filtered on HEPA 99.97%
- Photoperiod: 12 hrs dark / 12 hrs light (7 a.m. - 7 p.m.)

IN-LIFE DATES: From 14-JUL-1999 to 10-DEC-1999

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL/site

VEHICLE
Not applicable
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
Immediately and 72 hrs after the 3-min and the 1-hr exposure period in the first rabbit and at 1, 24, 48 and 72 hrs after the 4-hr exposure period (all rabbits)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: approximately 24 hours before the test, fur was clipped from the trunk of the animals. Care was taken not to abrade the skin. Only animals with intact skin were 0.5 mL of the test article were applied to a small area (approximately 6 cm²) of skin.
- % coverage: no data available
- Type of wrap if used: gauze patch

Firstly one rabbit was used and three treatment sites of the skin were prepared. On the first site the test article was applied for an exposure period of 3 minutes. Since no gross skin reactions were noted, the test article was applied for an exposure period of 1 hour on the second site. The application area was covered with a gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (occlusive patch). Since no gross reactions were observed after the one-hour exposure periods the test article was applied for an exposure period of 4 hours on the third skin site. This area was covered with a gauze patch as above. The test was completed using two additional animals with a 4-hour exposure period.
Adjacent areas of untreated skin of each animal served as control for the test.

REMOVAL OF TEST SUBSTANCE
- Washing: residual substance was wiped off.
- Time after start of exposure: at the end of each exposure period

SCORING SYSTEM:
The skin reaction was scored according to the scale presented in Table 1 below in "any other information on materials and methods incl. tables".
The dermal irritation was evaluated in conjunction with the nature and reversibility or otherwise of the responses observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 3 min and 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: exposure period: 3 min
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hr and 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: exposure period: 1 hr
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
other: 60 min, 24, 48 and 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: exposure period: 4 hrs
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 3 min and 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: exposure period: 3 min
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hr and 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: exposure period: 1 hr
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3
Time point:
other: 60 min, 24, 48 and 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: exposure period: 4 hrs
Irritant / corrosive response data:
No changes were seen at any test article application site.
Other effects:
Neither mortality nor adverse general clinical modifications were seen during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to this study, the test article was not classified as a dermal irritant.
Executive summary:

In a dermal irritation study performed according to OECD guideline 404 and in compliance with good laboratory practices (GLP), New-Zealand rabbits (3 males) were dermally exposed to 0.5 mL of test article (purity: 100 %) applied as such on 6 cm2 body surface area, on the skin of the trunk. Test sites were covered with an occlusive dressing for up to 4 hours. Irritation was scored based on erythema and oedema observed 3 min, 1, 24, 48 and 72 hrs after the end of application.

 

No general clinical signs were noted in any rabbit. No skin reactions were observed during the study. The mean score for the reading times 24, 48 and 72 hours of the 3 rabbits for both erythema and oedema was equal to 0. Therefore, in this study, the test article was not a dermal irritant.