Potassium tris(pentafluoroethyl)trifluorophosphate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 27 - June 25, 2008

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:

2008

Report date:

2008

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

Name:

Unnamed

Type:

Constituent

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: 8-12 weeks
- Weight at study initiation: 21.5+/- 1.6 g
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 6

Study design: in vivo (LLNA)

Vehicle:

other: ethanol/water = 70/30

Concentration:

0.5, 1, and 2.5%.

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS:
Experiment 1:
- number of animals: 2
- Concentrations: 5, 10, 25, and 50 % on one ear each
- Exposure duration/frequency: 3 consecutive days
- Observations: clinical signs 24 ± 4 hours after each application
- Results:
@5 and 10 %: no local signs of irritation but reduced spontaneous activity on day 6
@25 and 50%: reduced spontaneous activity after the first application of the test item and was found dead prior to the third application.

Experiment 2:
- number of animals: 2
- Concentrations: 5, and 10 % on both ears
- Exposure duration/frequency: 3 consecutive days
- Observations: clinical signs 24 ± 4 hours after each application
- Results:
@5 %: no local signs of irritation but reduced spontaneous activity on day 6
@10%: reduced spontaneous activity

Experiment 3:
- number of animals: 2
- Concentrations: 1, and 2.5 % on both ears
- Exposure duration/frequency: 3 consecutive days
- Observations: clinical signs 24 ± 4 hours after each application
- Results: no signs of systemic toxicity and no signs of local irritation have been observed

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Concentrations: 0.5, 1.0, and 2.5 %
- Criteria used to consider a positive response: Stimulation index > 3

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% 1.78
10% 1.84
25% 4.87

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Control: 1 0.5%: 2.34 1.0%: 1.36 2.5% 2.11

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Control: 385.1 0.5%: 901.9 1.0%: 524.2 2.5% 812.1

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

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 ethanol/deionized water (70/30) was assessed for its possible skin sensitising potential. For this purpose a local lymph node assay was performed using test item concentrations of 0.5, 1.0, and 2.5% (w/w). The concentrations have been selected in order to avoiding systemic toxicity and excessive local skin irritation as confirmed by a pre-experiment.
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 429.

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. The animals treated with 2.5 % of the test item had a slight increase in ear thickness that was statistically significant even though erythema formation was not observed. At lower concentrations a relevant increase in ear thickness did not occur.
In this study Stimulation Indices (S.I.) of 2.34, 1.36, and 2.11 were determined with the test item at concentrations of 0.5, 1.0, and 2.5% (w/w)  in ethanol/deionized water (70/30), respectively.

Conclusion

The test item was not a skin sensitiser under the test conditions of this study.