Fatty acids, C10-12, esters with polylactic acid, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 - 29 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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 (incl. QA statement)

Remarks:

Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, 55116 Mainz, Germany

Test material

Test material information

1

Reference substance name:

Fatty acids, C10-12, esters with polylactic acid, sodium salts

EC Number:

700-937-1

Cas Number:

1312021-45-6

Molecular formula:

not available

IUPAC Name:

Fatty acids, C10-12, esters with polylactic acid, sodium salts

Test material form:

liquid: viscous

Test animals / tissue source

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

SOURCE OF COLLECTED EYES
- Source: Slaughterhouse Muller Fleisch GmbH, Enzstr. 2.4, 75217 Birkenfeld, Germany
- Characteristics of donor animals (e.g. age, sex, weight): The cattle were between 12 and 60 months old.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were transported to the test facility in Hank's balanced salt solution (supplemented with antibiotics). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 h.
- Time interval prior to initiating testing: Fresh bovine eyes were obtained on the day of the test.
- Indication of any antibiotics used: 0.01% streptomycin and 0.01% penicillin

Test system

Vehicle:

physiological saline

Remarks:

CAS no: 7647-14-5

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl
- Concentration (if solution): 10% solution diluted in 0.9% sodium chloride solution

VEHICLE
- Amount(s) applied (volume or weight with unit): 675 µl
- Concentration (if solution): 0.9% solution of sodium chloride

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

2 h at 32°C.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure period (10 min) the corneas are rinsed with cMEM (complete Minimum Essential Medium) with phenol red and final rinsed with cMEM without phenol red, the anteriour chamber was filled with cMEM without phenol red, and the corneas were stored for additional 2 h at 32°C
- Time after start of exposure: Washing was done 10 min after an exposure period of 10 minutes.

SCORING SYSTEM: Calculation of in-vitro-irritancy score (IVIS)

TOOL USED TO ASSESS SCORE: Change in opacity of the corneas was determined based on change in absorption at 570 nm using a spectral photometer .

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

10 min

Value:

40.308

Other effects / acceptance of results:

Mean IVIS score for the test item (10% solution) was 46.308. According to OECD 437 (2009) a substance of IVIS < 55.1 may be considered as non - corrosive resp. not severely irritant.

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Conclusions:

There is regulatory acceptance in the EU that a substance can be considered corrosive (Eye Corrosive Cat. 1) based on a positive result in the Bovine corneal opacity and permeability test method. A result for which no prediction can be made is not conclusive with respect to non-classification or classification as an eye irritant and therefore requires further evaluation and/or data generation.