Hydrocarbons, C14-C16, n-alkanes, isoalkanes,

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15-Jul-2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics

EC Number:

940-728-4

Molecular formula:

Combination of mainly CnH2n+2 mainly within a carbon number range from C14 to C16. C14H30 to C16H34

IUPAC Name:

Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Storage condition of test material: At room temperature in the dark

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 750 µl per cornea

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea

POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 10% (w/v) Benzalkonium Chloride

Duration of treatment / exposure:

15 minutes

Details on study design:

TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- . After exposure the cornea was thoroughly rinsed to remove the test substance and incubated for 2 hours with fresh medium followed by opacity measurement and the permeability of the corneas was determined after a 90 minutes incubation period with sodium fluorescein.

- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).


TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
In vitro score range UN GHS
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
>55 Category 1

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

10 minutes

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

No permeability measurement was performed with one of the three corneas treated with test substance. This cornea was excluded from the IVIS determination. Since the cornea shifted in the holder after the opacity measurement it was impossible to perform a reliable permeability measurement with Na-fluorescein. It was therefore not possible to calculate an IVIS value for this cornea. Since this cornea gave reliable results for opacity and the other two cornea treated with the test substance gave reliable results for both opacity and permeability, this deviation had no influence on the study results

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An in vitro eye irritation study was conducted with Hydrocarbons, C14-C16, n-alkanes, isoalkanes, <2% aromatics (GS250), in accordance with OECD test guideline 437 and in compliance with GLP. The BCOP test did not indicate an irritancy potential based on either the opacity or permeability endpoints.

Executive summary:

The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 139 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

The test substance did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0 after 10 minutes of treatment.