Iodonium, bis[4-(1,1-dimethylethyl)phenyl]-, hexafluorophosphate(1-) (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 Dec 2011 - 08 Jan 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test material

Test material information

Constituent 1

Reference substance name:

bis(4-tert-butylphenyl)iodanium; hexafluoro-λ⁵-phosphanuide

EC Number:

620-341-4

Cas Number:

61358-25-6

Molecular formula:

C20H26F6IP

IUPAC Name:

bis(4-tert-butylphenyl)iodanium; hexafluoro-λ⁵-phosphanuide

Details on test material:

- Name of test material (as cited in study report): PF-6
- Physical state: white powder
- Analytical purity: 98.5%
- Purity test date: 2010-08-12
- Lot/batch No.: 20101020
- Expiration date of the lot/batch: 2012-04-12
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rabbit

Strain:

other: New Zealand White (Hsdlf:NZW)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.56-2.80 kg
- Housing: animals were housed individually in suspended cages.
- Diet: 2930C Teklad Global Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g (moistened with 0.5 mL distilled water to achieve a paste)

Duration of treatment / exposure:

animal 1: 3 min, 1h and 4 h; animals 2 and 3: 4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the back of the rabbit
- Type of wrap if used: the test substance was placed on a cotton gauze patch, which was held in contact with a strip of surgical adhesive tape. The trunk of the animal was wrapped in an elastic corset during exposure.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 3 min, 1 h and 4 h in animal 1; 4 h in animals 2 and 3

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean after 24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No effects on skin irritation were observed in animal 1 3 min and 1 h after test substance application. In the same animal very slight erythema was noted at the treated site of skin immediately and 1 h after exposure to the test substance for 4 h. Very slight erythema was also observed in animal 3 at the 24 and 48 h readiong time points after 4 h treatment. In animal 2, no skin irritation effects were noted at any of the observation time points.

Other effects:

No further local or systemic effects were observed.

Any other information on results incl. tables

The pH of the test substance at 10% (w/v) in aqueous solution was 4.5 (immediately) or 4.1 (after 10 min).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD not classified

Executive summary:

The skin irritation potential of PF-6 was investigated in a study according to OECD guideline 404 and GLP. The test substance (0.5 g moistened with 0.5 mL distilled water) was applied to the clipped skin of 3 young adult New Zealand White (Hsdlf:NZW) rabbits under semiocclusive conditions. The first animal was exposed to the test substance for 3 min, 1 h or 4 h, whereas in the further 2 animals treatment was performed for 4 h. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after patch removal. Exposure to the test substance for 3 min or 1 h did not elicit any skin reactions at the application site of the first animal at any of the observation time points. In the same animal, very slight erythema was observed 1 h after exposure to the test substance for 4 h, which was reversible within 24 h. Very slight erythema was also observed in the third animal at the 24 and 48 h, but not at the 72 h reading time point after 4 h treatment. In the second animal, no skin irritation effects were noted at any of the observation time points. No signs of systemic toxicity were seen in any of the animals tested. The mean erythema and edema scores after 24, 48 and 72 h were 0 for the first and second animal. In the third animal, the mean erythema and edema scores after 24, 48 and 72 h were 0.67 and 0, respectively.