Registration Dossier

Administrative data

Description of key information

skin irritation (human): slightly irritating
eye irritating (rabbit): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on skin and eye irritation are available for the substance dihexyl ether. The skin and eye irritation properties can be cross-read from the structurally related substance dioctyl ether:

Acute skin irritation:

The acute dermal irritation of dioctyl ether was tested undiluted (100% active matter) in 3 albino rabbits, strain New Zealand White. The contact time under semi-occlusive conditions was four hours. The 24/48/72 hours scores were 2.7 for the erythema and 2.3 for the oedema. The reactions disappeared totally within 21 days.

Dioctylether was tested in an occlusive 4-hr patch test. 19 volunteers were treated with the undiluted test substance and with a 50% concentration of dioctylether in 2-hexyl decanol. As a positive standard 2% Sodium Dodecyl Sulfate (SDS) was used which is classified as an irritant substance at a concentration of 2 %. The positive standard SDS 2% caused slight, moderate, strong and very strong reactions in 16 out of 19 volunteers, while the undiluted dioctylether caused slight and single moderate erythema in 8 out of 19 volunteers. The 50% concentration of dioctylether caused single slight erythema in 2 out of 19 volunteers. Thus, the reactions caused by dioctylether were significantly lower than the reactions caused by SDS 2%. Therefore, dioctylether was rated to be slightly irritating. A classification is not justified.

Based on the higher relevance of the test result obtained in the human study compared to the animal test, the human patch test has been used as key study.

Acute eye irritation:

An aliquot of 0.1 ml aqueous solution of the test article was instilled by a single application for a 24h contact into the eyes of 3 rabbits. The eyes were scored 24, 48 and 72 hours after application. The 24/48/72 hours mean scores were 0 for the cornea, 0 for the iris, 0.33 for the conjunctival erythema and 0.11 for the conjunctival oedema. The conjunctiva reactions abated completely within 72 hours. In summary, only mild effects were observed that were fully reversible. Therefore, the substance is considered to be slightly irritating.

Based on the similar structure for dihexyl ether also no skin and eye irritation is expected.

Justification for classification or non-classification

Based on data on the structurally-related substance dioctyl ether for skin irritation and for eye irritation, the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008).