4,4,5,5,6,6,7,7,8,8,9,9,9-tridecafluorononyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate

EC Number:

218-407-9

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate

Cas Number:

2144-53-8

Molecular formula:

C12H9F13O2

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate

Details on test material:

-Purity: 99.7%

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Adjacent areas of untreated skin were used for comparison.

Duration of treatment / exposure:

4 hours

Observation period:

3 minutes, and 1, 24, and 72 hours after test substance removal

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: range of means for 3 animals

Time point:

other: 1 hour to 72 hours

Score:

0.3 - 1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

other: range of means for 3 animals

Time point:

other: 1 hour to 72 hours

Score:

0 - 0.3

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Other effects:

Four hours exposure to 0.5 mL of the test item resulted in very slight or well-defined erythema and very slight or well-defined oedema in the treated skin areas of the three rabbits. The skin irritation had resolved within 48 hours after exposure in two animals and within 72 hours in the other animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Very slight or well-defined erythema and very slight or well-defined oedema was observed. The skin irritation had resolved within 72 hours.

Executive summary:

The test substance was evaluated for acute skin irritation potential in 3 New Zealand White rabbits. The test sites were covered with a semi-occlusive dressing to ensure contact between the skin and test substance. The animals were exposed to the test substance for 4 hours. The test sites were evaluated and scored according to a numerical scale, 1, 24, and 72 hours after the end of the 4-hour exposure period.  Exposure to the test substance resulted in very slight or well-defined erythema and very slight or well-defined oedema in the treated skin areas of the three rabbits. The skin irritation had resolved within 48 hours after exposure in two animals and within 72 hours in the other animal.