Triglycerides, C16-C18 (even numbered) and C18 (unsaturated), maleated

Endpoint summary

Description of key information

Skin: not irritating (OECD 439)
Eyes:

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-12-09 to 2014-12-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

other: EU Method B.46 (Skin Irritation)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany

Amount / concentration applied:

liquids: 10 µL

Duration of treatment / exposure:

15 minutes

Observation period:

42 +/- 1 h

Details on study design:

The test was performed on EpiSkin, an organotypic reconstructed three-dimensional model of the human epidermis. 3 replicate tissues are dosed with the test item, the negative control (10µL PBS) and the positive control (10µL 5% SDS), respectively. After 15 minutes treatment period at room temperature the test item and the controls are rinsed off with PBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours. Isopropanol extracts are measured photometrically at 550 nm.

The test item showed no direct MTT reducing capability and no colouring potential.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: OECD 439

Conclusions:

The test item is classified as "non-irritant" (No Category).

Executive summary:

In the in vitro skin irritation test using the EpiSkin human epidermis model 10 µL were applied topically for 15 minutes. After 42 h post-incubation cytotoxic effects were determined via MTT reduction assay.

[The mean relative tissue viability (% negative control) was > 50%.

The test item is therefore classified as "non-irritant" (UN GHS: No Category).]

This study is classified as acceptable:

OD₅₅₀ of the blank is < 0.1.

Mean OD₅₅₀ of the three negative control tissues is >= 0.6 and <= 1.5.

Mean relative tissue viability of the three positive contol tissues is <= 40%.

Standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is < 18%.

This study satisfies the requirement for Test Guideline OECD 439 for in vitro skin irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

The skin irritation potential of High oleic sunflower oil, maleated was evaluated in an in vitro test performed according to OECD guideline 439 and GLP with the, a reconstituted three-dimensional human epidermis model EPISKIN ™. Since the relative tissue viability was >50% after 15min topical exposure and a 42 h post incubation period compared to control values, the substance was not found irritating to skin.

Fatty acids, C14-18 and C16-18-unsatd., maleated was found to be irritating to skin a study performed in accordance with OECD 439 and GLP, but not corrosive to skin when tested in an in vitro corrosion test according to OECD 431, respectively.

Glycerol was not found to be irritating to skin in survey evaluating intra- and interlaboratory variability in testing on skin and eye irritation. Beside laboratory-specific methods, a reference method has been used by the laboratories resulting in a primary irritation score to compare the results.

Eye

Irritation to eye by High oleic sunflower oil, maleated was evaluated in a bovine corneal opacity and permeability assay performed in accordance with OECD guideline 437 and GLP. As a result a mean in vitro irritation score of 32.52 for the test substance was found, which does not allow a conclusion on the irritation potential.

Consequently, the substance was tested in accordance with OECD 405, where 0.1 mL of this substance was instilled into the eyes of three rabbits. The resulting mean irritation scores for corneal opacity, iris, conjunctival redness and chemosis were found to be XXXX, respectively. Consequently, High oleic sunflower oil, maleated is regarded as XXXX to eyes.

Glycerol was not found to be irritating to eyes in survey evaluating intra- and interlaboratory variability in testing on skin and eye irritation. Beside laboratory-specific methods, a reference method comparable to OECD 405 has been used by the laboratories using the Draize scoring system to compare the results.

Fatty acids, C14-18 and C16-18-unsatd., maleated was not found to be corrosive to eyes in a study performed in accordance with OECD 438. Moreover, this substance was not found to be irritating to eyec when tested in an in vivo study under GLP and according to 405.

Justification for selection of skin irritation / corrosion endpoint:
GLP-Guideline study

Justification for selection of eye irritation endpoint:
GLP-Guideline study

Justification for classification or non-classification

The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.