Registration Dossier

Administrative data

Description of key information

2,3-Epoxypropyl neodecanoate was assessed for both eye and skin irritating potential in several rabbit studies.  Based on the findings of current O.E.C.D. Testing Guideline GLP studies 2,3-epoxypropyl neodecanoate is not an eye or skin irritant.  In a four hour exposure acute inhalation study conducted at the saturated vapor concentration of 26 ppm no evidence of respiratory irritation was observed.    

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:
no adverse effect observed (not irritating)

Respiratory irritation

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

Additional information

When 2,3 -epoxypropyl neodecanaoate was evaluated for skin irritating potential in a GLP, O.E.C.D. 404, "Acute Dermal Irritation/Corrosion" Testing Guideline study the findings demonstrated only transient intermittent reactions. Therefore, the test substance was not irritating to rabbit skin under the conditions of the study. In older studies employing prolonged (24 hr) exposures with occlusion, evidence of irritation was observed in rabit skin. However, these severe conditions of exposure are not relevant for assessing human skin irritation potential.

2,3 -Epoxypropyl neodecanoate was assessed for eye irritation in the rabbit in two separate studies including a GLP, O.E.C.D. 405, "Acute Eye Irritation/Corrosion" study. The findings from the rabbit eye irritation studies demonstrated that 2,3 -epoxypropyl was not irritating to the eye.

In a four hour acute inhalation study conducted at the saturated vapor concentration of 26 ppm, no evidence of respiratory tract irritation was observed.

Justification for classification or non-classification

Findings from multiple eye and skin irritation studies conducted with 2,3 -epoxypropyl neodecanoate demonstrate that Classification as an eye or skin irritant is not required based on the criteria established by EU Directive 67/548/EEC, the EU CLP and the Globally Harmonized System (GHS).