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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 January 2014 to 16 January 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted in compliance with OECD 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

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: 03 August 2012
- Lot/batch No.: 41260127919/ Lot 2
- Storage condition of test material: At room temperature in the dark
- Other:

Test animals / tissue source

Species:

other: in vitro

Strain:

other: not applicable

Details on test animals or tissues and environmental conditions:

Not applicable: in vitro method

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: in vitro method: positive (10% w/v Benzalkonium Chloride) and negative (physiological saline) controls were utlilized.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL

Duration of treatment / exposure:

Corneas were incubated with the test article for 10 minutes at 32 degrees C.

Observation period (in vivo):

Following the 10 minute exposure, the corneas were rinsed and incubated in cell culture medium for 120 minutes. Opacity readings were conducted following the 120 minute incubation. The corneas were then placed in Na-fluorescein medium and incubated for 90 minutes. Following the indubations, permeability was measured.

Number of animals or in vitro replicates:

None, in vitro method.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following the 10 minute exposure, the corneas were rinsed in cell culture
- Time after start of exposure: 10 minutes

SCORING SYSTEM: Opacity and permeability readings were normalized to the negative control values.

TOOL USED TO ASSESS SCORE: opacitometer, microplate reader for sodium fluorescein permeability reading.

Results and discussion

In vivo

Results

Irritation parameter:

other: in vitro irritation score (IVIS)

Basis:

mean

Time point:

other: 10 minute exposure

Score:

ca. -1

Irritant / corrosive response data:

Based on the results of the study, the test article is not an irritant to the cornea (IVIS = -1.0)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of the study, the test article is not an irritant to the cornea (IVIS = -1.0)

Executive summary:

The corneal irritation and damage potential of the test article (Clear colorless liquid, Batch: 41260127919/Lot 2) was tested in the Bovine Corneal Opacity and Permeability test (BCOP test). The study was performed in compliance with OECD GLP (98) 17 (1997). The test method was based on OECD no. 437 (2009), EC No. 440/2008 B. 47 (2010), OTWG- ICCVAM-NICEATM (2006), INVITTOX 127 (2006), and Gautheron, P. et al. 18: 442-449 (1992). Corneas were prepared in cell culture medium and incubated at 32 C for at least 1 hour prior to exposure. Corneas (3/group) were treated with 0.75 mL of undiluted MTDID 30531 test material and incubated in a horizontal position for 10 minutes at 32 C. A positive control (10% w/v Benzalkonium Chloride) and a negative control (physiological saline) were tested in parallel with the test material. At the end of the exposure period, the corneas were rinsed and incubated in fresh cell culture medium for 120 +/- 10 minutes at 32 C. Opacity was evaluated using an opacitometer after the 2 hour post-exposure incubation. Following opacity readings, the cell culture medium was replaced with Na-fluorescein medium and incubated for approximately 90 minutes at 32 C. Following the 90 minute Na-fluorescein exposure, permeability was measured. The mean in vitro irritation score (IVIS) was calculated and the scores were classified according to protocol defined categories. For the test article, the mean IVIS = -1.0 after 10 minutes. The mean opacity score was -1 and the mean permeability score was -0.001 (range -0.007 to 0.007). Controls performed as expected. No pH effect of the test substance was observed on the rinsing medium. Based on the results of the study, the test article is not an irritant to the cornea (IVIS = -1.0).