Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, 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:

From Sepetember 10,2012 to September 12,2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant with international guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

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)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

TALLOELFETTSAEURE-C15+-ALKYLESTER, SULFONIERT, NA-SALZ

IUPAC Name:

TALLOELFETTSAEURE-C15+-ALKYLESTER, SULFONIERT, NA-SALZ

Constituent 2

Reference substance name:

Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts

EC Number:

270-307-4

EC Name:

Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts

Cas Number:

68424-50-0

Molecular formula:

UVCB

IUPAC Name:

Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts

Test material form:

liquid: viscous

Details on test material:

- Name of test material: Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts
- Molecular formula: UVCB
- Physical state: liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Purity test date:
- Lot/batch No.:CH159604/01
- Expiration date of the lot/batch:05 June 2013
- Storage condition of test material:the storage conditions for the test item will be room temperature.

Test animals / tissue source

Species:

other: bovine eye

Strain:

other: no data

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:Butcher Service s.r.l.
- Age at study initiation:6-12 months
- Killing time: Before 12:30 in the morning
- Approximate test starting time: 13:45
- Mounting in the chamber:Each cornea was mounted into a prewarmed testing chamber with the endothelial surface of the cornea placed in contact with the O-ring of the posterior part of the chamber. Care was taken to ensure the correct position of the cornea minimizing the presence of pigmented area inside the O-ring and avoiding movements which would damage the cornea. The chamber was then filled with complete EMEM without phenol red maintained at 32 ± 1°C (posterior part of the chamber first to maintain convexity).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

Corneas were exposed in horizontal position for 10 ± 1 minutes, incubated in a liquid bath at 32 ± 1°C.

Observation period (in vivo):

Corneas were maintained in horizontal position, for further 2 hours ± 10 minutes, incubated in a liquid bath at 32 ± 1°C.

Number of animals or in vitro replicates:

a total of 14 corneas were processed (out of 16 delivered) for a final selection of the 9 required corneas according to basal opacity.

Details on study design:

- Positive control item:1% (w/v) sodium hydroxide (NaOH; Sigma, batch no. BCBG2025V) in water (Baxter, batch no. 12A3102), being the test item a liquid.
- Negative control item:Physiological saline (0.9% NaCl; BieffeMedital batch no. 10I0208) as a control of the test system.

- Eyes transport solution:Hanks balanced salt solution (HBSS) Modified [Gibco Cat. no. 14025 (batch no. 1150029)] supplemented with Penicillin sulphate (Sigma batch no. BCBC7535V) and Streptomycin sulphate (Sigma batch no. 079K14101) both at the final concentration of 100 IU/mL.
- Complete EMEM*
- without phenol red:EMEM* Gibco (Invitrogen) Cat. no. 51200 (batch no. 1099742) supplemented with 1% (v/v) Foetal Bovine Serum (FBS - Hyclone - batch no. AWH20368)
- with phenol red:EMEM* Gibco (Invitrogen) Cat. no. 21090 (batch no. 1098654) supplemented with 1% (v/v) Foetal Bovine Serum (FBS - Hyclone - batch no. AWH20368).
*also named: Minimum Essential Medium Eagle's (MEM) Modified or MEM or Eagle’s MEM. These media were prewarmed in a water bath at 32°C during the experimental procedure.
- Sodium fluorescein solution:Sigma Cat. no. F-6377 (batch no. 079K0141). This was formulated to give 4 mg/mL solutions in DPBS [Gibco Cat. No. 14190 (batch no. 1098734)].
Method used
-Test item: open chamber method being the test item a viscous substance (gel).
-Positive and negative controls: closed chamber method being the controls free-flowing substances.

TOOL USED TO ASSESS SCORE:the permeability was asssessed by fluorescein

Results and discussion

In vitro

Results

Irritation parameter:

other: IVIS score

Value:

2.4

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The test item increased very slightly the corneal opacity, being the calculated mean value 2.0. At the macroscopic observation the three corneas did not show any abnormality. With reference to the cornea permeability, this was slightly affected when compared to that of negative control, thus indicating a minimal alteration of corneal barrier. The calculated mean permeability OD490 value was 0.0247.

Any other information on results incl. tables

The positive control induced opacity of the whole cornea surface with a mean increase of the opacity value equal to 115.0. Opacity and exfoliation were noted in the three replicates at the end of the 2-hour post-incubation period. The corneal permeability was also increased. The calculated mean permeability OD490 value was 2.3830.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The potential of the test item, TALLOELFETTSAEURE-C15+-ALKYLESTER, SULFONIERT, NA-SALZ, to be severely irritant or corrosive to the eye, was measured by its ability to induce opacity and increase a permeability in isolated bovine corneas.
Slight alterations of cornea opacity and permeability were recorded after treatment with the test item. The IVIS score for the test item was 2.4.
The negative and positive controls gave the expected results. The test is therefore considered as valid.
According to the OECD Guideline no. 437, the test item is not to be classified as corrosive or severely irritant to the eye.
Moreover, according to the criteria stated in the OECD Supplement to Test Guidelines nos. 437 and 438, there is no indication of an irritant effect to the eye.

Executive summary:

The potential of the test item, TALLOELFETTSAEURE-C15 +-ALKYLESTER, SULFONIERT, NA-SALZ, to cause corrosion/severe irritation by using the Bovine Corneal Opacity and Permeability (BCOP) assay, was examined in agreement with OECD Guideline no. 437 (adopted on) and OECD Supplement to Test Guidelines nos. 437 and 438. The test item was used as supplied (being a gel) on the epithelial surface of three idoneous bovine corneas, for an exposure period of 10 minutes plus a post incubation period of 2 hours. Positive and negative controls [a 1% (w/v) sodium hydroxide solution in water and physiological saline alone, respectively] were concurrently tested in the same number of replicates. The mean opacity detected with an opacitometer at the end of the test item exposure period was 2.0, slightly higher than that of the negative control. At the macroscopic observation the three corneas did not show any abrnormality. After the determination of opacity, the epithelial surface was treated with a 0.4% solution of sodium fluorescein in DPBS for 90 minutes, to investigate alteration in cornea permeability. Mean OD₄₉₀value of the corneas treated with the test item wasslightly affected when compared to that of negative control, thus indicating a minimal alteration of corneal barrier. The calculated mean permeability OD₄₉₀value was 0.0247. Negative and positive controls gave the expected results.The results obtained indicate that the test item induces very slight changes in cornea opacity and in corneal permeability under the reported experimental conditions. The calculatedin vitroirritancy score (IVIS) for the test item is 2.4. According to the OECD Guideline no. 437, the test item is not to be classified as corrosive or severely irritant to the eye. Moreover, according to the criteria stated in theOECD Supplement to Test Guidelines nos. 437 and 438,there is no indication of an irritant effect to the eye.