Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Both for the skin and eye irritation, key studies were available according to internationally accepted testing and GLP guidelines, demonstrating that the test material is slightly irritating to skin and eye.  Supporting studies were available for triethyleneglycol-bis(2-ethylhexanoic acid) ester, indicating that the substance is a mild skin irritant, but not an eye irritant. Responses were not severe enough to warrant any classification.

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

Two in vivo studies reported on skin irritation.

A key study was performed with single application of 0.5 mL of the test material (99.1% purity) to the skin of three rabbits for 4 hours (Sanders, 2007c). This study was conducted according to internationally accepted testing and GLP guidelines, and was considered to be reliable, adequate and relevant. Very slight erythema was noted at all treated skin sites at the 24 and 48-hour observations and at one treated skin site at the 72-hour observation.The test material produced a primary irritation index of 0.7/4 and was classified as mild irritant to rabbit skin according to Draize classification scheme. No corrosive effects were noted.

A supporting, acute dermal irritation/corrosion test was carried out according to OECD 404, with administration of 0,5 mL of triethyleneglycol-bis(2-ethylhexanoic acid) ester to the skin of three male rabbits for 4 hours (Mürmann, 1989a). Dermal irritation and corrosion were scored at 1, 24, 48 and 72 h and 6 days after removal of the test substance. In all animals, very light to clear erythema and swelling arose, that had completely disappeared after 6 days. The irritation index was 1.25/8 which led to the conclusion that a one time dermal application in male rabbits is slightly irritating.

 

Two in vivo studies reported on eye irritation.

A key study was performed with single application of 0.1 mL of the test material (99.1% purity) to the eye of three rabbits (Sanders, 2007d). This study was conducted according to internationally accepted testing and GLP guidelines, and was considered to be reliable, adequate and relevant. The test material produced minimal conjunctival irritation; two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.The test material produced a maximum group mean score of 3,3 and was classified as a minimal eye irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

A supporting eye irritation/corrosion test (Mürmann, 1989b) was carried out according to OECD 405 with administration of 0,1 mL of triethyleneglycol-bis(2-ethylhexanoic acid) ester under the right eyelid of each of three male rabbits and evaluation at 1, 24, 48 and 72h and 6 days after application. The test chemical had no effect at all on cornea or iris, whereas conjunctiva redness was observed in all three animals 1 hour after application,however with complete recovery within 24 to 48h after application. With an irritation index of 0,67/110 this test material was considered not irritating.

 

 


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the skin/eye irritation scores determined in the discussed study reports, no classification is required.