Registration Dossier

Administrative data

Description of key information

Acute toxicity study data was available for 2,3-epoxypropyl neodecanoate for all three routes of administration: oral, dermal and inhalation.  The findings demonstrate that 2,3-epoxypropyl neodecanoate is not acutely toxic by these three routes of administration.  

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

2,3 -Epoxypropyl neodecanoate had an acute oral LD50 value of > 2000 mg/kg of body weight in rat O.E.C.D. Testing Guideline GLP study. The acute rat dermal LD50 value for 2,3 -epoxypropyl neodecanoate in an O.E.C.D. 402 Testing Guideline GLP study was > 2000 mg/kg of body weight. No mortalities occured at the saturated vapor concentration of 240 mg/m3 (26 ppm) in a rat 4 hr inhalation study. Therefore, the estimated 4 hr LC50 value for 2,3 -epoxypropyl neodecanoate is > 240 mg/m3 (26 ppm). These findings demonstrate that 2,3 -epoxypropyl neodecanoate is not acutely toxic by the oral, dermal and inhalation routes of administration.


Justification for selection of acute toxicity – oral endpoint
REACH Annex VII requirement.

Justification for selection of acute toxicity – dermal endpoint
REACH Annex VIIi requirement.

Justification for classification or non-classification

Study data demonstrate that 2,3 -epoxypropyl neodecanoate is not acutely toxic by the oral, dermal and inhalation routes of administration. Therefore, Classification for acute toxicity is not required.