Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine was found to be irritating to skin, but not corrosive, in in vitro studies using the EpiDerm™ skin model conducted according to OECD Test Guidelines (Dreher, 2012a and b). In eye irritation studies, while the substance was not irritating in an in vitro BCOP assay, it was irritating to rabbit eyes in a study in vivo.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

The skin corrosion potential of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine was investigated in an in vitro EpiDerm™ study, conducted in accordance with GLP, OECD Test Guideline 431 and EU Method B.40 (Dreher, 2012a). Duplicate EpiDerm™ inserts were treated with the test article, distilled water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and for 1 hour. At the end of the treatment period, the tissues were washed with phosphate buffered saline (PBS) and cell viability was assessed using the 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) assay. The skin corrosivity potential was assessed based on the remaining cell viability obtained after test material treatment at the two treatment times. Skin viability after a three minutes or one hour of exposure to the test article was 61% and 35%, respectively. Skin viability after a three minutes or one hour of exposure to the positive control article was 22% and 11%, respectively, demonstrating appropriate performance of the assay. The test article was not corrosive to skin in the in vitro skin model; EpiDerm™.

The skin irritation potential of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine was investigated in an in vitro EpiDerm™ study, conducted in accordance with GLP, OECD Test Guideline 439 and EU Method B.46 (Dreher, 2012b). In the study, EpiDerm™ SIT (EPI-200) inserts were treated with test article, negative control (phosphate buffered saline (PBS)) and positive control (5% w/v sodium dodecyl sulphate (SDS)) for 60 minutes. At the end of the treatment period, the tissues were washed with PBS and cell viability was assessed using the MTT assay. The skin irritation potential was assessed according to the remaining cell viability obtained after test article treatment. The group mean viabilities were: 5.6% for the test article, 100% for the negative control and 10.7 % for the positive control. The test article was identified as a skin irritant in the in vitro skin model EpiDerm™ SIT (EPI-200) and met the criteria for classification as a Category 2 Skin Irritant according to Regulation (EC) No 1272/2008.

Eye irritation

The potential for Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine to cause corrosion or severe irritation to the eyes was evaluated in excised bovine corneas using the bovine corneal opacity and permeability (BCOP) assay, conducted according to OECD Test Guideline 437 and GLP (Dreher, 2013b). In the study, a volume of 750 µL test material was applied to three separate corneas, followed by a 10 minute incubation period at 32°C ± 1°C. Following incubation, each cornea was washed with media containing phenol red, followed by media without phenol red. The opacities were then measured and the anterior chamber was emptied. To evaluate permeability, sodium fluorescein solution was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes. Following incubation, the media in the posterior chamber was removed and three 350 µL aliquots of the media (per cornea) were analysed for optical density at 490 nm (OD490). The opacity and permeability measurements were used to calculate an In Vitro Irritancy Score (IVIS). The calculated IVIS for the test material was 31.90. As this was below the trigger value of 55.1, the test material was not considered to be corrosive or severely irritating to the eye. However, a further confirmatory test was conducted in an in vivo study.

The potential for Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine to cause eye irritation in vivo was investigated in an eye irritation study in the rabbit conducted according to OECD Test Guideline 405 and GLP (Dreher, 2013c). In the study, undiluted test article (0.1 mL) was instilled into one conjunctival sac of a New Zealand White rabbit on Day 1. Occular reactions were assessed for 21 days after treatment. Instillation of the test article produced easily discernible translucent areas of corneal opacity, iridial inflammation and severe conjuctival irritation. The effects on the cornea, iris and conjunctiva did not reverse within the 21 day observation period. The substance was therefore found to be corrosive to the eye in rabbits.


Justification for selection of skin irritation / corrosion endpoint:
Reliable study providing data from a guideline compliant study. Under the conditions of this study, the test substance was determined to be irritating to skin.

Justification for selection of eye irritation endpoint:
Sole study; guideline and GLP compliant. Under the conditions of this study, the test article was found to be severely irritating to the eye.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Skin irritation/corrosion

Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine was identified as a skin irritant in the in vitro skin model; EpiDerm™ SIT (EPI-200). On this basis, the substance meets the criteria for classification as Category 2, H315 “Causes skin irritation” according to Regulation (EC) No 1272/2008, and as Xi, R38 “Irritating to skin” according to Directive 67/548/EEC.

Eye irritation

Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine was found to cause irreversible effects on the eye in an eye irritation study in the rabbit conducted according to OECD Test Guideline 405. On this basis, the substance meets the criteria for classification as Category 1, H318 “Causes serious eye damage” according to Regulation (EC) No 1272/2008 and Xi, R41 “Risk of serious damage to eyes” according to Directive 67/548/EEC.