Registration Dossier
Registration Dossier
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EC number: 231-838-7 | CAS number: 7758-29-4
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: Study performed to guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Pentasodium triphosphate
- EC Number:
- 231-838-7
- EC Name:
- Pentasodium triphosphate
- Cas Number:
- 7758-29-4
- Molecular formula:
- H5O10P3.5Na
- IUPAC Name:
- pentasodium bis(phosphonatooxy)phosphinate
- Details on test material:
- - Name of test material (as cited in study report): Sodium tripolyphosphate (STPP)
- Physical state: White solid
- Storage condition of test material: Room temperature in the dark
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 UK limit
- Age at study initiation:
- Weight at study initiation: 15-23g
- Housing: individually in suspended solid floor polypropylene cages
- Diet (e.g. ad libitum): certified rat and mouse diet ad libitum
- Water (e.g. ad libitum):mains tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25-30
- Humidity (%): 19-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 04/03/2008 To: 26/04/2008
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% pluronic L92 in distilled water
- Concentration:
- 1, 2.5 and 5%
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:LLNA
- Criteria used to consider a positive response:Test material regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in HTdR incorporation compared to control values
TREATMENT PREPARATION AND ADMINISTRATION: Freshly prepared in 1% pluronic L92 in distilled water
daily application of 25µl of 1, 2.5 or 5% w/w test material - Positive control substance(s):
- other: 2,4-Dinitrobenzenesulfonic acid, sodium salt
Results and discussion
- Positive control results:
- 2,4-dinitrobenzenesulfonic acid, sodium salt in 1% pluronic L92 in distilled water
Concentration, Stimulation index, Result
1%, 1.80, Negative
5%, 4.32, Positive
10% , 11.98, Positive
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 1% 1.27 2.5% 1.17 5% 1.31
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle 2501.00 1% 3176.25 2.5% 2938.16 5% 3279.54
Any other information on results incl. tables
Concentration (% w/w) in 1% pluronic L92 in distilled water |
DPM |
DPM/node |
Stimulation index |
Results |
Vehicle |
2501.00 |
312.63 |
n.a. |
n.a. |
1 |
3176.25 |
397.27 |
1.27 |
Negative |
2.5 |
2938.16 |
367.27 |
1.17 |
Negative |
5 |
3279.54 |
409.94 |
1.31 |
Negative |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Sodium tripolyphosphate is not a sensitiser under the conditions of the test
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