Registration Dossier
Registration Dossier
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EC number: 700-540-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 03 - 23, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD TG 429
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate
- EC Number:
- 700-540-3
- Molecular formula:
- C27H28F21NaO12S
- IUPAC Name:
- sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test: 10-11 weeks; Main test: 9 - 10 weeks
- Weight at study initiation: Pre-test: 22.4 g; Main test: 20.7+/- 1.5 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 6
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10, and 25 % (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 50% in MEK
- Irritation: No
- Lymph node proliferation response: -
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3
TREATMENT PREPARATION AND ADMINISTRATION: - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Standard statistical methods have been applied for data processing.
Results and discussion
- Positive control results:
- Conc. SI
0%: 1.0
5% 1.6
10% 2.4
25% 5.9
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Control: 1 5%: 1.1 10%: 1.5 25% 2.1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Control: 404.. 5%: 436.8 10%: 604.4 25% 850.8
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- From the data it can be concluded that the test item is not a skin sensitiser under the conditions of this assay.
- Executive summary:
Study Design
In the study the test item formulated in MEK was assessed for its possible skin sensitising potential. The GLP study was performed according to OECD TG 429.
For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25% (w/w). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by a pre-experiment.
Results
The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. A statistically significant or biologically relevant increase in ear thickness values was not observed in any of the treatment groups in comparison to the vehicle group. In this study Stimulation Indices (S.I.) of 1.1, 1.5, and 2.1 were determined with the test item at concentrations of 5, 10, and 25% (w/w) in MEK, respectively. A clear dose response was observed.
Conclusion
The test item was not a skin sensitiser under the test conditions of this study.
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