Spiro[piperidine-1,1'-pyrrolidinium] bifluoride

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

2017

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: test was technically not feasible due to the physical-chemical properties of the test item

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Spiro[piperidine-​1,​1'-​pyrrolidinium] bifluoride

Cas Number:

1803551-73-6

Molecular formula:

C9 H18 N . F2 H

IUPAC Name:

Spiro[piperidine-​1,​1'-​pyrrolidinium] bifluoride

Test material form:

solid: granular

Details on test material:

Batch RFR 6861-2-3

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

commercially available test method

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: epiCS® (CellSystems, Troisdorf, Germany).
- Cat.-No: CS-1001

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: RT (room temperature)
- Temperature of post-treatment incubation (if applicable): Incubator temperature: 37 ± 2° C (CO2 gas concentration: 5 %; Humidity: maximum)

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 hours
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm

PREDICTION MODEL / DECISION CRITERIA:
- Corrosivity potential of test materials is predicted from the cell viabilities obtained after 3 min and 60 min treatment compared to the negative control. A chemical is classified "corrosive" (sub-category 1A) if the cell viability after 3 min treatment is decreased by more than 50 %. If cell viability after 3 min exposure is ≥ 50 %, while it is below 15 % after 60 min exposure the substance is also classified as corrosive, but sub-category 1 B/1 C. If cell viability after 3 min exposure is ≥ 50 % and after 60 min exposure ≥ 15 %, the substance is classified as non-corrosive.

Control samples:

yes, concurrent negative control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 0.9% NaCl

Duration of treatment / exposure:

3 and 60 minutes

Number of replicates:

3

Results and discussion

In vitro

Other effects / acceptance of results:

Under the conditions of the assay the test item became electrostatically charged, therefore an even distribution on the epidermal surface and proper conduction of the assay could not be achieved. Hence the results on viability were considered unreliable and not reported here. No prediction on the corrosive potential of the test item and thus no conclusion on classification according to UN GHS was drawn.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Executive summary:

A study for predicting a non-specific, corrosive potential of the test item by using reconstructed human epidermis (test method epiCS®) was initiated according to OECD TG 431. However, under the conditions of the assay the test item became electrostatically charged, therefore an even distribution on the epidermal surface and proper conduction of the assay could not be achieved. Hence the results on viability were considered unreliable and not reported here. No prediction on the corrosive potential of the test item and thus no conclusion on classification according to UN GHS was drawn.