N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate

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)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Crl:NMRI Br (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item tetraethylammonium perfluorobutane sulfonate

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

tetraethylazanium nonafluorobutane-1-sulfonate

EC Number:

700-536-1

Cas Number:

25628-08-4

Molecular formula:

C12H20F9NO3S

IUPAC Name:

tetraethylazanium nonafluorobutane-1-sulfonate

Constituent 2

Reference substance name:

N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate

IUPAC Name:

N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate

Details on test material:

content: 97.7%

In vivo test system

Test animals

Species:

mouse

Strain:

NMRI

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

Group 1 Vehicle (DMF)
Group 2 2% tetraethylammonium perfluorobutane sulfonate (in DMF)
Group 3 10% tetraethylammonium perfluorobutane sulfonate (in DMF)
Group 4 50% tetraethylammonium perfluorobutane sulfonate (in DMF)
Group 5 30% Alpha Hexyl Cinnamic Aldehyde (in DMF)

No. of animals per dose:

6 animals/test item group and 6 control animals

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

Direct LLNA (NMRI mice, female, 6 animals/group) Groups Weight index Cell count index (index of mean +/- SD in %) Gr. 1 1.00 +/- 20.37 1.00 +/- 24.54 Gr. 2 0.91 +/- 17.55 0.70x +/- 25.33 Gr. 3 0.89 +/- 20.23 0.65x +/- 22.50 Gr. 4 0.86 +/- 13.45 0.63x +/- 16.39 Gr. 5 1.71x +/- 22.21 1.56x +/- 18.42 Ear swelling (NMRI mice, female, 6 animals/group, in 0.01 mm) Groups day 1 day 4 Index day 4 (mean +/- SD in %) Gr. 1 17.25 +/- 2.62 17.67 +/- 2.79 1.00 Gr. 2 17.67 +/- 3.69 18.00 +/- 4.10 1.02 Gr. 3 17.33 +/- 2.84 17.92 +/- 2.87 1.01 Gr. 4 17.25 +/- 3.60 17.83 +/- 3.24 1.01 Gr. 5 17.50 +/- 2.98 23.67x +/- 11.58 1.34 3. Ear weight (NMRI mice, female, 6 animals/group, in mg per 8 mm diameter punch) Dose (%) day 4 Index day 4 (mean +/- SD in %) Gr. 1 11.74 +/- 5.21 1.00 Gr. 2 11.38 +/- 8.26 0.97 Gr. 3 11.28 +/- 7.66 0.96 Gr. 4 12.18 +/- 6.71 1.04 Gr. 5 16.51x +/- 10.74 1.41 x = statistically significant decrease (p< 0.05) x = statistically significant increase (p< 0.05)

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: not applicable

Any other information on results incl. tables

Compared to vehicle-treated animals, none of the parameters measured in the substance-treated groups, i.e. cell counts and weights of the draining lymph nodes, ear weights and ear swelling, reached or exceeded the "positive levels" defined for this assay. These results show that there is no indication for a skin sensitizing effect after administration of a concentration up to and including 50% tetraethylammonium perfluorobutane sulfonate in this test system.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Executive summary:

The modified Local Lymph Node Assay (IMDS) was performed in 2010 on 24 female NMRI mice of the strain Crl:NMRI BR (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item tetraethylammonium perfluorobutane sulfonate.

This study was carried out with NMRI mice from commercial breeder Charles River Germany, which is not the normally used breeder of the lab. Therefore, a concurrent control of 6 animals treated with Alpha Hexyl Cinnamic Aldehyde was included.

The study was conducted according to OECD Guidelines No. 429 and No. 406, EC Guideline 2004/73/EC (29th Adaptation of Guideline 67/548/EEC, B.42)/Health Effects Test Guideline and OPPTS 870.2600 (EPA) with the following test item concentrations:

Test item: 0 (vehicle control), 2%, 10% and 50%.

Positive control: 30% Alpha Hexyl Cinnamic Aldehyde

The test item and the positive control were formulated in dimethylformamide (DMF) to yield solutions.

Compared to vehicle-treated animals, none of the parameters measured in the substance-treated groups, i.e. cell counts and weights of the draining lymph nodes, ear weights and ear swelling, reached or exceeded the "positive levels" defined for this assay. These results show that there is no indication for a skin sensitizing effect after administration of a concentration up to and including 50% tetraethylammonium perfluorobutanesulfonate in this test system.

In conclusion, these results show that the test item tetraethylammonium perfluorobutane sulfonate has no sensitizing potential in mice after dermal application of up to and including a 50% concentration. No indication for a non-specific (irritant) activation was detected, too. Therefore, the concentration of 50% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.

These results are verified by the comparison with the results of the positive control group (Alpha Hexyl Cinnamic Aldehyde).