1-Hexene, 3,3,4,4,5,5,6,6-octafluoro-6-iodo-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 February 2014 to 13 February 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted in compliance with GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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

Test material

Test material information

Constituent 1

Reference substance name:

MTDID 30531

IUPAC Name:

MTDID 30531

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): MTDID 30531
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 98.6%
- Purity test date: 10 January 2012
- Lot/batch No.: 41260127919/Lot2
- Storage condition of test material: At room temperature in the dark.

Test animals

Species:

other: NA: in vitro method: Human-derived keratinocytes were utilized

Strain:

other: NA: in vitro method

Details on test animals or test system and environmental conditions:

Not Applicable: in vitro method

Test system

Type of coverage:

other: NA: in vitro method

Preparation of test site:

other: NA: in vitro method

Vehicle:

unchanged (no vehicle)

Controls:

other: None: in vitro method. Positive (KOH) and negative (Milli-Q water) controls were utilized.

Amount / concentration applied:

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

Duration of treatment / exposure:

2 tissues were treated for 3 minutes, while another two were treated for an hour.

Observation period:

Tissues were washed following exposure, and incubated with MTT medium for 3 hours. Formazan was then extracted with 2 mL isopropanol and the amount of extracted formazan was determined spectrophotometrically.

Number of animals:

None: in vitro method.

Details on study design:

Human-derived keratinocytes were cultured to form a multilayered, highly differentiated model of the human epidermis. The tissues were kept refrigerated until the day of use, transferred to 6 well plates containing 0.9 mL DMEM medium, and then incubated for 2.5 hours at 37 C in 5% CO2. MTDID 30531 (50 uL) was applied to 2 tissues for a 3 minute exposure and to 2 tissues for 1 hour exposure. The negative control (Milli-Q water) and the positive control (Potassium hydroxide- 8.0 normal solution) were applied (50 uL of each) in the same manner. Following the exposure periods, the tissues were washed with phosphate buffered saline (PBS). The DMEM medium was replaced with 300 uL MTT medium and then all tissues were again incubated for 3 hours at 37 C in 5% CO2. The tissues were then washed with PBS and formazan was extracted with 2 mL isopropanol. The amount of extracted formazan was determined spectrophotometrically at 540 nm in triplicate. Cell viability was then calculated as a percentage of the mean of the control tissues, and skin corrosion potential calculated from the optical density at 540 nm (OD540) measurements.

Results and discussion

In vivo

Results

Irritation parameter:

other: Tissue viability compared to negative controls

Basis:

mean

Time point:

other: 3 minute and 60 minute

Score:

ca. 88 - ca. 95

Remarks on result:

other: 3 Min: 88%, 60 Min: 95%

Irritant / corrosive response data:

The mean tissue viability of test article treated cells was 88% of the negative control after a 3 minute exposure and 95% after 1 hour exposure. The controls performed as expected indicating that the test was valid

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Category 2 Criteria used for interpretation of results: EU

Conclusions:

Based on the results of the study, the test article is not corrosive in the in vitro skin corrosion test model and met the requirements of the test

Executive summary:

The skin corrosion potential of the test article (clear colorless liquid, Batch: 41260127919j/Lot 2) was evaluated in an in vitro human skin model test. METHODS: This study was performed in compliance with OECD GLP (1997). The study design was based on OECD Guideline No. 431 (2013) and EC 440/2008 (2008). Human-derived keratinocytes were cultured to form a multilayered, highly differentiated model of the human epidermis. The tissues were kept refrigerated until the day of use, transferred to 6 well plates containing 0.9 mL DMEM medium, and then incubated for 2.5 hours at 37 C in 5% CO2. The test article (50 uL) was applied to 2 tissues for a 3 minute exposure and to 2 tissues for 1 hour exposure. The negative control (Milli-Q water) and the positive control (Potassium hydroxide- 8.0 normal solution) were applied (50 uL of each) in the same manner. Following the exposure periods, the tissues were washed with phosphate buffered saline (PBS). The DMEM medium was replaced with 300 uL MTT medium and then all tissues were again incubated for 3 hours at 37 C in 5% CO2. The tissues were then washed with PBS and formazan was extracted with 2 mL isopropanol. The amount of extracted formazan was determined spectrophotometrically at 540 nm in triplicate. Cell viability was then calculated as a percentage of the mean of the control tissues, and skin corrosion potential calculated from the optical density at 540 nm (OD540) measurements. The mean tissue viability of test article treated cells was 88% of the negative control after a 3 minute exposure and 95% after 1 hour exposure. The controls performed as expected indicating that the test was valid. Based on the results of the study, the test article is not corrosive in the in vitro skin corrosion test model and met the requirements of the test. As the study was performed according to OECD 431, a classification of Category 2 irritant was assigned.