Registration Dossier

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).