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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 - 30 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:

rabbit

Strain:

other: New Zealand White (Hsdlf:NZW)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.1 kg
- Housing: the animal was housed in a suspended cage.
- 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): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL (volume measured with a syringe, corresponds to 90 mg)

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals or in vitro replicates:

1

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: the animal was killed for humane reasons immediately after the 7-day observation period

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Irritant / corrosive response data:

Single application of the test substance to the eye of one rabbit induced scattered or diffuse corneal opacity at the 24 and 48 h readings. Translucent corneal opacity was observed 72 h and 7 days post-application. In addition, a small area of opalescent corneal opacity was observed at the 72 h reading and blood stained discharge occurred 7 days post-application. Iridial inflammation was noted in the animals at the 24, 48 and 72 h readings as well as 7 days after test substance application. Moderate to severe conjunctival redness and chemosis were observed in the animal at the 24, 48 and 72 h as well as the 7 day observation time points. All effects on the treated eye were not reversible within the 7-day observation period.

Other effects:

Due to worsening reactions and signs of pain and discomfort, the animal was killed for humane reasons immediately after the 7-day observation period.

Any other information on results incl. tables

MEASUREMENT OF pH

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

RABBIT ENUCLEATED EYE TEST

In the preliminary Rabbit Enucleated Eye Test (REET), the test substance was not found to cause effects on corneal thickness, corneal opacity, corneal epithelium, and fluorescein uptake in the enucleated eyes of New Zealand white rabbits.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Eye Dam. 1, H318
DSD: Xi, R41

Executive summary:

The eye irritation potential of PF-6 was investigated according to OECD guideline 405 and in compliance with GLP. The undiluted test material (0.1 mL) was placed into the conjunctival sac of one eye of 1 New Zealand White (Hsdlf:NZW) rabbit. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h as well as 7 days after application. Single application of the test substance to the eye of one rabbit induced scattered or diffuse corneal opacity at the 24 and 48 h readings. Translucent corneal opacity was observed 72 h and 7 days post-application. In addition, a small area of opalescent corneal opacity was observed at the 72 h reading and blood stained discharge occurred 7 days post-application. Iridial inflammation was noted in the animals at all reading time points during the 7-day observation period. Moderate to severe conjunctival redness and chemosis were observed in the animal at the 24, 48 and 72 h as well as the 7 day observation time points. None of the observed effects on the treated eye was reversible within the 7-day observation period. Due to worsening reactions and signs of pain and discomfort, the animal was killed for humane reasons immediately after the 7-day observation period. The mean cornea, iris, conjunctivae and chemosis scores after 24, 48, and 72 h were 1.3, 1, 2 and 2.3 in the animal, respectively.