1,3-propanesultone

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 May - 24 May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Version / remarks:

adpoted in 2015

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: ICCVAM, Sample Protocol: “CORROSITEX® - A Validated And Accepted Dermal Corrosion Test Method For Classifying Substances According To UN Packing Groups”

Version / remarks:

adopted in 2003

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Mainz, Germany

Test material

Test material information

Constituent 1

Reference substance name:

1,3-propanesultone

EC Number:

214-317-9

EC Name:

1,3-propanesultone

Cas Number:

1120-71-4

Molecular formula:

C3H6O3S

IUPAC Name:

1,2λ⁶-oxathiolane-2,2-dione

Test material form:

solid

In vitro test system

Test system:

artificial membrane barrier model

Vehicle:

unchanged (no vehicle)

Details on test system:

SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: Yes (InVitro International, Irvine CA, USA)
- Components: The test system consists of two components: a proteinaceous macromolecular gel (= synthetic biobarrier) on a permeable membrane and a fluid, the Chemical Detection System (CDS)
- Apparatus and preparation procedures: The biobarrier was produced on the day the assay was performed. The entire contents of the biobarrier diluent vial were added slowly to the matrix powder to ensure complete and uniform solubilisation. The vial containing the solution was placed in a water bath on a heating plate set to 68°C with the stir switch set to maintain 200 rpm for the stir bar. The solution was warmed to 68 °C and stirred for 20 min to solubilise the biobarrier matrix. Then the heating plate was switched off and the solution was left to stand for 10 minutes. In the next step 200 μL of the solubilised matrix were pipetted onto the membrane discs. The membrane discs with the biobarrier were stored in the fridge (2 - 8°C) for a period of 5 hours before use.

WAS THE COMPATIBILITY TEST PERFORMED: For the qualification screen, 108.8 mg of the test item were added to the “qualification test tube”.
The test item induced a colour change in the CDS immediately and is therefore qualified for the determination of its skin corrosion potential with the Corrositex®-Test.

WAS THE TIMESCALE CATEGORY TEST PERFORMED: The categorisation screen was used to choose the appropriate scoring scale. The screen was performed by adding 103.2 mg (tube A) and 100.4 mg (tube B) of the test item to two different test tubes (A and B) which contained an acid resp. a base buffer. The content of the individual tubes was then mixed and the resulting colours were observed after one minute.
Since no colour change could be observed in either tube, two drops of the “confirm reagent” were added to tube B; this was mixed and the resulting colour was used to confirm the category. The categorisation kit and colour chart provided by Romer Labs Deutschland GmbH were used to determine the category. The test item was classified in category 2.

TEMPERATURE USED DURING TREATMENT: no data

METHOD OF DETECTION
- Chemical detection system (CDS) was used.

METHOD OF APPLICATION: A membrane disc coated with the biobarrier was placed into a vial containing the CDS and the control resp. test item was applied. Each replicate was observed until a break-through occurred or for the maximum observation time. First, one vial was exposed to the test item and a stop watch was started. The vial was observed for 3 min. continuously. Since no colour change or any other change in the CDS was visible within 3 minutes, the remaining 3 vials were exposed to the test item in 1 minute intervals.

NUMBER OF REPLICATES: 4 vials were used for quadruplicate measurement of the test item, 4 vials were used for the positive control, 4 vials were used for the negative control and 2 vials were used as colour reference for the CDS, respectively.

NUMBER OF INDEPENDENT EXPERIMENTS TO DERIVE FINAL PREDICTION: 1

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if observable changes in CDS solution were observed after > 30 - 60 min (Category 1C), > 3 - 30 min (Category 1B) and 0 - 3 min (Category 1A).
- The test substance is considered to be non-corrosive to skin if observable changes in CDS solution were not observed after > 60 min.

Control samples:

yes, concurrent negative control

yes, concurrent vehicle

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: ca. 500 mg (496.8, 505.1, 508.0 and 510.9 mg)

NEGATIVE CONTROL
- Amount applied: 500 µL
- Concentration: 10%

POSITIVE CONTROL
- Amount applied: ca. 120 mg (120.3, 122.9, 118.6 and 120.5 mg)
- Concentration: 100% (solid pellets)

Duration of treatment / exposure:

1 h (category 2)

Number of replicates:

quadruplicate measurement

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

treatment with the test item

Value:

> 60

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
The negative control did not induce a change in the colour of the CDS reagent after > 60 minutes.
- Acceptance criteria met for positive control:
The positive control showed a distinct change in the colour of the CDS reagent in the time interval of 8 - 16 minutes (recorded breakthrough times: 11 - 14 minutes).

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification as corrosive required according to Regulation (EC) No. 1272/2008

Conclusions:

Under the conditions of this test, the test substance did not show corrosive properties towards the skin in the in vitro Membrane Barrier Test for Skin Corrosion using Corrositex®.