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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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 429 (Skin Sensitisation: Local Lymph Node Assay)

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.42 (Skin Sensitisation: Local Lymph Node Assay)

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 870.2600 (Skin Sensitisation)

Deviations:

no

Remarks:

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

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

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%

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/J

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

0.0%, 25%, 50% or 100% v/v

No. of animals per dose:

5

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Concentration 25% - Stimulation Index 0.9 Concentration 50% - Stimulation Index 0.6 Concentration 100% - Stimulation Index 0.7

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Control - 194 DPM 25%- 176 DPM 50% - 122 DPM 100% - 130 DPM

Any other information on results incl. tables

No irritation of the ears was observed in any of the animals examined. No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The body weight loss noted for some animals was considered not toxicologically significant since the changes were slight in nature and no concentration-related incidence was apparent.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The test material was considered to be a non-sensitiser under the conditions of the test.

Executive summary:

A study was performed to assess the skin sensitisation potential of the test material in the CBA/J strain mouse following topical application to the dorsal surface of the ear. Three groups, each of five animals, were treated with 50 µl (25µl per ear) of the test material as a solution in dimethylformamide at concentrations of 25%, 50% or 100% v/v. An additional group of four animals was treated with dimethylformamide alone. All Stimulation Index readings were below 1.0. The test material was considered to be a non-sensitiser under the conditions of the test.