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Toxicological information

Skin sensitisation

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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:
2008
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

Constituent 1
Chemical structure
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 triphosphate
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

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