Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritancy: not irritating

Eye irritancy: severe eye irritant

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritancy

In an old, well reported skin irritation study that followed the basic principles of the current OECD guideline, 2 white Vienna rabbits were treated for 20 hours to the substance 3,6,9,12-tetraoxahexadecan-1-ol under occlusive conditions. No adverse skin reaction was seen.

Eye irritancy

In a guideline GLP eye irritation study, the substance 3,6,9,12-tetraoxahexadecan-1-ol was tested in rabbit eyes to assess the level of eye irritancy produced. Under the conditions of the test, moderate eye irritation was observed, the most acute response being moderate to severe conjunctival erythema and mild to cornal opacity. All symptoms disappeared within 14 days. 

In an in vitro assay designed to assess the irritation potential for severe eye damage, 3,6,9,12-tetraoxahexadecan-1-ol was testsed in the HET-CAM = (Hen Egg Test - Chorioallantoic Membrane) assay. The level of response seen was not indicative of a severe eye irritant.

Justification for classification or non-classification

Based on the information available, skin irritancy does not appear to be a significant characteristic of this substance and therefore labelling is not required.

In a guideline eye irritation study, all symptoms disappeared within 14 days. However, the corneal response and the amount of redness produced over the first threee days did meet the criteria for classification under the GHS as a severe eye irritant (Cat 2A).