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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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 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

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