Fatty acids, sunflower-oil, conjugated

Endpoint summary

Description of key information

Irritation / corrosion:
- skin: not irritating (OECD 404, human data; Analogy CAS 67001-08-0);
- eyes: irreversible effects (OECD 405; Analogy CAS 143-07-7, CAS 67001-08-0);

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin

Due to lack of reliable data with fatty acids (sunflower oil, conjugated) on skin irritation, studies with fatty acids C16-18 (even numbered) and C18-unsatd. are used for the hazard assessment. Since fatty acids (sunflower oil, conjugated) and fatty acids C16-18 (even numbered) and C18-unsatd. have comparable compositions and belong to the same category based on similar structural and toxicological properties, this approach can be regarded as scientifically justified. Thus, read-across is performed based on a category approach (for details refer to IUCLID chapter 13).

Skin irritation by fatty acids C16-18 (even numbered) and C18-unsatd. was evaluated in a study performed according to GLP and OECD guideline 404 and EU method B.4. Four Kleinrussen rabbits received a dermal application of 0.5 g fatty acids C16-C18 and C18 unsat. to the shaved skin of the back under occlusion for 4 hours. The resulting mean scores after 24 – 72 hours for edema and erythema were 1.8 and 1.0, respectively. While the erythema reactions were reversible in 10 days, the observed edema reactions diapered within 7 days. Based on this finding, fatty acids C16-C18 and C18 unsat. can be regarded as not irritant to skin (Kästner, 1988).

In addition to studies with animals two studies with human volunteers were available for assessment. In the first study, 10µL offatty acids C16-C18 and C18 unsat.at concentration of 50 % was applied to the back of 20 subjects for 24 hours using a Large Finn Chamber on Scanpor (Herma). No reactions were found when the application sites were evaluated 1, 6, 24, 48, 72 and 14 hours later, respectively (Matthies, 1988). In the second study with volunteers, the test substance at a concentration of 80% was applied to the forearm of 10 volunteers, which was repeated every 30 seconds for 30 minutes. The reactions were scored 1 and 24 hours after the last application until disappearance of the symptoms. As result, 1/10 subjects showed erythema with the lowest score after 30 min, which disappeared after 30-35 min. The other subjects did not show any symptoms (Matthies, 1988).

Together the results of the human and anima studies show thatfatty acids C16-C18 and C18 unsat. are not irritating to skin.

 

Since fatty acids C16-C18 and C18 unsat. and fatty acids (sunflower oil, conjugated) have similar compositions and belong to the same category due to similar structural and toxicological properties, the same result is expected for fatty acids (sunflower oil, conjugated). Thus, they are not irritating to skin.

 

 

Eye

Due to lack of reliable data with fatty acids (sunflower oil, conjugated) on eye irritation, studies with fatty acids C16-18 (even numbered) and C18-unsatd. are used for the hazard assessment. Since fatty acids (sunflower oil, conjugated) and fatty acids C16-18 (even numbered) and C18-unsatd. have comparable compositions and belong to the same category based on similar structural and toxicological properties, this approach can be regarded as scientifically justified. Thus, read-across is performed based on a category approach (for details refer to IUCLID chapter 13).

Eye irritation was analyzed in a study performed according to GLP and OECD guideline 405 and EU method B.5. 0.1 g of fatty acids C16-C18 and C18 unsat. was instilled into the right eyes of three Kleinrussen rabbits, while the left eyes served as controls. While no corneal or iris reactions were noted, only slight conjunctival effects were noted which were disapperad within at least 24 hours. The resulting mean scores after 24 – 72 hours for corneal opacity, iris, conjunctibal erythema and chemosis were found to be all 0, respectively. Thus, fatty acids C16-C18 and C18 unsat. can be regarded as not irritating to eyes.

 

Since fatty acids C16-C18 and C18 unsat. and fatty acids (sunflower oil, conjugated) have similar compositions and belong to the same category due to similar structural and toxicological properties, the same result is expected for fatty acids (sunflower oil, conjugated). Thus, they are not irritating to eyes.

Justification for classification or non-classification

The substance may contain few of lauric acid (C12), which is classified as R41/eye damage Cat 1. and The specific concentration limit for the lauric acid is established as 73.6% based on a reliable experimental data. According to DPD (1999/45/EC) or CLP (1272/2008/EC) classification criteria for irritation/corrosion, fatty acids C14-18 and C16-18-unsatd. do not fulfill the criteria for classification and thus a non-classification is warranted for this endpoint, as the concentration of C12 is lower than 73.6%.