Registration Dossier

Administrative data

Description of key information

Low  toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 064 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
3 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 640 mg/kg bw

Additional information

Neodecanoic acid has a low potential for toxicity via the oral, inhalation, and dermal routes. 

 

Oral

Male and female rats were gavaged with neodecanoic acid at concentrations of 1, 1.5, 2, 3, or 4 ml/kg to assess acute oral toxicity.  All animals that died during the study did so within 3 days of exposure. Signs of toxicity included lethargy, hypothermia, piloerection, dyspnea, and ataxia. Based on these results, it is concluded that the LD50 is approximately 2.27 ml/kg (2066 mg/kg). 

 

Dermal

In a study that assessed acute dermal toxicity, male and female rats were exposed to 4 ml/kg (3640 mg/kg) neodecanoic acid via an occluded dermal patch for 24 hours. After 24 hours, the patch was removed and clinical observations were made once daily for 9 days. There were no deaths observed in this study and there were no signs of a toxicity response.  It is concluded that the LD50 is greater than 3640 mg/kg. 

 

Inhalation

In acute inhalation study, male Wistar rats and Swiss albino mice (10/sex/species) were exposed the test substance vapour via a whole-body exposure at 3.0 mg/L for 6 hours with a subsequent 14 day observation period. No mortality or significant signs of toxicity were observed during the 6-hour exposure period. No deaths occurred in mice or rats throughout the study and no significant observations were made at necropsy. The LC50 is therefore greater than 3 mg/l (3000 mg/m3). 

Justification for classification or non-classification

No classification for acute toxicity (dermal or inhalation) is indicated according to the general classification and labelling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.