4-bromo-3,3,4,4-tetrafluorobut-1-ene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

19 February 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

9 October 2017

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-bromo-3,3,4,4-tetrafluorobut-1-ene

EC Number:

242-440-8

EC Name:

4-bromo-3,3,4,4-tetrafluorobut-1-ene

Cas Number:

18599-22-9

Molecular formula:

C4H3BrF4

IUPAC Name:

4-bromo-3,3,4,4-tetrafluorobut-1-ene

Test material form:

liquid

Test animals / tissue source

Species:

cattle

Strain:

other:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Neat

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Run / experiment:

1

Value:

-0.1

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks:

Yes: 52.1

Results 2

Irritation parameter:

cornea opacity score

Run / experiment:

1

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

Yes: 0.7

Positive controls validity:

valid

Remarks:

Yes: 32.3

Results 3

Irritation parameter:

fluorescein retention score

Run / experiment:

1

Value:

-0.007

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

Yes: 0.011

Positive controls validity:

valid

Remarks:

Yes: 1.315

Any other information on results incl. tables

Table 1 summarizes the results of the BCOP assay. The followng prediction models were used to evaluate the ocular irritancy potential as described by Sina et al. (1995)[2] for non-regulatory purposes or as described in OECD TG437 (2017). 

 

The prediction model according to Sina et. al based on a wide range of materials (note: While this classification system provides a good initial guide to interpretation of these in vitro data, these specific ranges may not be applicable to all classes of materials or other exposure times. Whenever possible, results should be compared to "benchmark" materials tested under similar exposure conditons.): 

 

In Vitro Score	Sina et al Prediction
≤ 25	Mild irritant
> 25 ; ≤ 55	Moderate irritant
> 55	Severe irritant

 

Prediction model outlined in OECD TG 437:

In Vitro Irritation Score (IVIS)	UN GHS
≤ 3	No Category
> 3; ≤ 55	No prediction can be made*
> 55	Category 1

*- Additional testing would be required for a definitive classification of ocular irritation potential according to GHS

 

The BCOP assay was accepted when the positive control (ethanol) produced an In Vitro Score that fell within two standard deviations of the historical mean. The current acceptance range for ethanol is 37.9-63.4. 

 

[2] Sina, J.F., Galer, D.M., Sussman, R.G., Gautheron, P.D., Sargent, E.V., Leong, B., Shah, P.V., Curren, R.D., and Miller, K. (1995) A collaborative evaluation of seven alternatives to the Draize eye irritation test using pharmaceutical intermediates. Fundamental and Applied Toxicology 26:20-31.

Applicant's summary and conclusion

Interpretation of results:

other: No Category

Conclusions:

According to the current OECD test guideline 437 (OECD TG 437) the test substance is predicted to not require classification or labeling for ocular irritation according to the Globally Harmonized System (GHS No Category).

Executive summary:

The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test substance, BTFB, also referred to as 4-Bromo-3,3,4,4-tetrafluorobut-1-ene (CAS 18599-22-9). Bovine corneas, obtained as a byproduct from freshly slaughtered animals, were mounted in special holders and exposed to the test substance for 10 minutes + 2 hrs post exposure period. The test substance was tested neat. An In Vitro Score was determined for the test substance based on the induction of opacity and permeability (to fluorescein) in the isolated bovine corneas. The In Vitro Score obtained for the test substance was -0.1. The test substance would be classified as a mild irritant according to the classification system established by Sina Scale (i.e. In Vitro Score ≤ 25). According to the OECD test guideline 437 (OECD TG 437) the test substance is predicted to not require classification or labeling for ocular irritation according to the Globally Harmonized System (GHS No Category).