1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

2010

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene

EC Number:

817-766-4

Cas Number:

91891-42-8

Molecular formula:

C6F12O

IUPAC Name:

1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
3M Company
- Expiration date of the lot/batch:
No data
- Purity test date:
05 Feb, 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Room temperature and humidity, protected from light and stored under enert gas
- Stability under test conditions:
Stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
: None, dosed unchanged

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: Highly differentiated 3D tissue model consisting of normal, human-derived epidermal keratinocytes

Cell source:

other: No data

Source strain:

other: NA

Details on animal used as source of test system:

SOURCE ANIMAL : Human
- Source: MatTek

Justification for test system used:

Test system validated in OECD 439.

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm
- Tissue batch number(s): Lot 28838
- Production date: No data
- Shipping date: No data
- Delivery date: 17 July, 2018
- Date of initiation of testing: 18 July, 2018

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 C
- Temperature of post-treatment incubation (if applicable): 37 C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Per the report the tissues were "thoroughly rinsed".
- Observable damage in the tissue due to washing: None reported.
- Modifications to validated SOP: None

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: μQuant Plate Reader, Bio-Tek Instruments, Winooski, VT
- Wavelength: 540 nm
- Filter: No data
- Filter bandwidth: No data
- Linear OD range of spectrophotometer: No data

NUMBER OF REPLICATE TISSUES: 3

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
Following the 60 minute exposure, the viability was then expressed as a percent of control values. If the mean tissue viability was 50% or less, the test material was classified as an irritant; if the mean tissue viability was more than 50%, the test material was classified as a non-irritant.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 uL

VEHICLE : None

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): 5% SDS

Duration of treatment / exposure:

60 minutes

Duration of post-treatment incubation (if applicable):

24 hours

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Mean

Value:

103.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: None
- Direct-MTT reduction: None
- Colour interference with MTT: None

DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study (103.1% tissue viability) the test article is not irritating in the EpiDerm skin irritation model.

Executive summary:

The skin irritation potential of the test article was evaluated in the 3D Reconstructed Human Epidermis model EpiDerm (MatTek). The study was conducted according to OECD 439 in compliance with OECD GLP principles. Tissues were dosed in triplicate with 30 uL test article, negative control (PBS) or positive control (5% SDS) and incubated at 37 C for 60 minutes. Following the 60 minute exposure period, tissues were rinsed with PBS, blotted to remove the test substance and dry the tissue and transferred to fresh medium. The rinsed tissues were then incubated for 24 hours, rinsed again and incubated for an additional 18 hours in fresh medium. At the end of the incubation period, each tissue was rinsed with PBS and transferred to a 24 -well plate containing 300 uL of MTT solution (1 mg/mL in DMEM). The tissues were incubated for 3 hours with MTT. Following MTT incubation, each tissue was rinsed with PBS and treated with 2.0 mL of extracant solution (isopropanol) for at least two hours with shaking. Two aliquots per tissue of the extracted MTT formazan were measured at 540 nm to determine viability when compared to control values. Tissues exposed to the test article for 60 minutes had a tissue viability of 103.1% with negative controls having 100% viability and positive controls having 2.3% viability. Based on the results of the study (103.1% tissue viability) the test article is not irritating in the EpiDerm skin irritation model.