Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Irritating to the skin and eyes.

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)

Additional information

Skin

A skin irritation study in rabbits has been undertaken with CAS number 68526-84-1.

 

In the key study with CAS number 68526-84-1, rabbits were subjected to a 4-hour exposure to isononanol via a semi-occlusive dermal application.  Dermal reactions were scored to erythema and edema according to the method of Draize at 45 minutes, 24, 48, and 72 hours and 7 days post patch removal.  All animals exhibited some signs of erythema and edema within 48 hours post patch removal.  The mean skin irritation scores between 24 and 72 hours were: erythema 1.83 and edema 0.22. All six animals exhibited desquamation by Day 7.

 

Eye

An eye irritation study in rabbits has been undertaken with CAS number 68526-84-1.

 

In the key study, 6 rabbits had their left eye instilled with 0.1 ml of isononanol (CAS number 68526-84-1) and were evaluated for signs of eye irritation at 1, 24, 48 and 72 hours and 7 days post exposure according to the method of Draize.  Slight signs of irritation were noted within 1 hour post exposure, but these effects were resolved by the seven day observation point.  Mean eye irritation scores between 24 and 72 hours were: corneal opacity score 0.83, iritis score 0.61, conjunctival redness 1.44, and conjunctival oedema 1.06. CAS number 68526 -84 -1 produced a mean corneal opacity score of ≥1 in 5 of 6 individual animals.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin

The data for the substance identified by CAS number 68526-84-1, subject of this registration, was demonstrated in a well-documented GLP study conducted according to recognized testing methodologies to produce skin irritation. This assessment is based on desquamation noted in all 6 animals at Day 7.

 

Isononanol CAS number 68526-84-1 is therefore classified as irritant to skin according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) and the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.

 

Eye

The data for the substance identified by CAS number 68526-84-1, subject of this registration, was demonstrated in well documented GLP study conducted according to recognized testing methodologies to produce eye irritation at a level that warrants classification. 

Isononanol with CAS number 68526-84-1 is therefore classified as irritant to eye, according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) (R41) and the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008 (Category 2 Eye Irritant).