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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in compliance with international guidelines

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

other: CBA/CaBkl and CBA/CruBR

Sex:

female

Details on test animals and environmental conditions:

Two female CBA/Ca (CBA/CaBkI) strain mice were supplied by B & K Universal Ltd, Hull, UK and seventeen female CBA/Ca (CBA/Ca CruBR) strain mice were supplied by Charles River UK Limited, Margate, Kent, UK. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were in the weight range of 15 to 23 g, and were eight to twelve weeks old.
The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food (Certified Rat and Mouse Diet) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25 °C and 30 to 70%, respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.

Vehicle:

other: the test item was used undilited and reshly prepared in dimethyl formamide.

Concentration:

Preliminary test: Three mice were treated by daily application of 25 µl of the undiluted test material or the test material at concentrations of 50% or 25% v/v in dimethyl formamide, to the dorsal surface of each ear for up to three consecutive days (Days 1, 2, 3).
Main test: Groups of four mice were treated with the test material at concentrations of 5%, 10% or 25% v/v in dimethyl formamide.

No. of animals per dose:

main test: 4 mouse per dose

Details on study design:

Main test: Groups of four mice were treated with the test material at concentrations of 5%, 10% or 25% v/v in dimethyl formamide. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
Five days following the first topical application of the test material (Day 6) all mice were injected via the tall vein with 250 µl of phosphate buffered saline (PBS) containing 3H-methyl thymidine (3HTdr: 80 µCi/ml, specific activity 2.0 Ci/mmol, GE Healthcare UK Ltd) giving a total of 20 µCi to each mouse.
Termination: Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group I ml of PBS was added to the pooled lymph nodes.
Determination of 3HTdR Incorporation: After approximately eighteen hours incubation at approximately 4 °C, the precipitates were recovered by centrifugation at 2100 rpm (approximately 450 g) for ten minutes, resuspended in 1 ml of TCA and transferred to 10 ml of scintillation fluid (Optiphase Trisafet). 3HTdR incorporation was measured by p-scintillation counting.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

not applicable

Positive control results:

hexyl cinnamic aldehyde was considered to be a sensitizer under the condition of the test.

Key result

Parameter:

SI

Value:

1.06

Test group / Remarks:

5% v/v in dimethyl formamide

Key result

Parameter:

SI

Value:

1.92

Test group / Remarks:

10% v/v in dimethyl formamide

Key result

Parameter:

SI

Value:

1.2

Test group / Remarks:

25% v/v in dimethyl formamide

Individual clinical observation and mortality data for test and control animals were recorded.

There were no death. No signs of systemic toxicity were noted in the test or control animals during the test.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was considered to be a non-sensitizer 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/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:

- OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002)

- Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/73/EC

Following a preliminary screening test, three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in dimethyl formamide (DMF) at concentrations of 25%, 10% or 5% v/v. A further group of four animals was treated with dimethyl formamide alone.

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

Conc. (% v/v) in DMF	Stimulation Index	Result
5	1.06	Negative
10	1.92	Negative
25	1.20	Negative

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear according to OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay”.

Following a preliminary screening test, three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in dimethyl formamide (DMF) at concentrations of 25%, 10% or 5% v/v. A further group of four animals was treated with dimethyl formamide alone.

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group were as follows:

at 5% conc. (% v/v) in DMF the S.I. found was 1.06

at 10% conc. (% v/v) in DMF the S.I. found was 1.92

at 25% conc. (% v/v) in DMF the S.I. found was 1.20

Thus, the Stimulation Index (S.I.) was below 3 at all concentrations tested and the substance was found to be tested negative for skin sensitisation under the conditions of the test.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The available in vivo study indicates that the notifiable substance is not sensitizing to skin. Thus, the data are conclusive but not sufficient for classification for skin sensitization.

No data is available to address respiratory sensitisation. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008.