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EC number: 260-375-3 | CAS number: 56773-42-3
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 - well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 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 the is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item tetraethylammonium perfluorooctane sulfonate
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Tetraethylammonium heptadecafluorooctanesulphonate
- EC Number:
- 260-375-3
- EC Name:
- Tetraethylammonium heptadecafluorooctanesulphonate
- Cas Number:
- 56773-42-3
- Molecular formula:
- C8H20N.C8F17O3S
- IUPAC Name:
- N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane-1-sulfonate
- Details on test material:
- content: 99.1%
Constituent 1
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 perfluorooctane sulfonate (in DMF)
Group 3 10% tetraethylammonium perfluorooctane sulfonate (in DMF)
Group 4 50% tetraethylammonium perfluorooctane sulfonate (in DMF)
Group 5 30% Alpha Hexyl Cinnamic Aldehyde (in DMF) - No. of animals per dose:
- 6 animals/dose
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- 1. Direct LLNA (NMRI mice, female, 6 animals/group) Groups Weight index Cell count index (index of mean +/- SD in %) Gr. 1 1.00 +/- 23.31 1.00 +/- 33.84 Gr. 2 1.03 +/- 21.79 1.03 +/- 39.24 Gr. 3 0.99 +/- 15.69 1.00 +/- 18.07 Gr. 4 1.16 +/- 25.40 1.12 +/- 38.46 Gr. 5 1.61x +/- 11.74 1.78x +/- 8.00 2. 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 16.67 +/- 4.67 17.33 +/- 5.68 1.00 Gr. 2 17.58x +/- 4.51 17.83 +/- 4.02 1.03 Gr. 3 17.58x +/- 4.51 17.17 +/- 4.86 0.99 Gr. 4 17.67x +/- 4.41 17.50 +/- 4.56 1.01 Gr. 5 17.50 +/- 5.71 24.75x +/- 16.45 1.43 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 11.41 +/- 9.79 1.00 Gr. 2 11.54 +/- 8.26 1.01 Gr. 3 10.99 +/- 6.20 0.96 Gr. 4 11.11 +/- 7.82 0.97 Gr. 5 16.95x +/- 13.25 1.49 * = DMF x = statistically significant increase (p< 0.05)
- 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 perfluorooctane sulfonate in this test system.
On day 1, i.e. before treatment, slight statistically significant increases in ear swelling had been determined for group 2, 3 and 4. These changes are, however, within the normal range of variance for these parameters, which means that it is only of statistical significance because the mathematical conditions were favorable.
Substance specific effects were not determined.
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 perfluorooctane 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 [6, 8, 9]. These results show that there is no indication for a skin sensitizing effect after administration of a concentration up to and including 50% Perfluoroktansulfonsäure tetraethylammonium Salz in this test system.
On day 1, i.e. before treatment, slight statistically significant increases in ear swelling had been determined for group 2, 3 and 4. These changes are, however, within the normal range of variance for these parameters, which means that it is only of statistical significance because the mathematical conditions were favorable.
Substance specific effects were not determined.
In conclusion, these results show that the test item tetraethylammonium perfluorooctane sufonate 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).
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