Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
3 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
0.2 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute oral toxicity

The acute median lethal oral doses (LD50) to male and female rats of DEGDB were calculated to be 4843 mg/kg bodyweight (males), 3535 mg/kg bodyweight (females), and 4190 mg/kg bodyweight (both sexes). In similar studies conducted earlier, the LD50 was determined to be >3000 mg/kg bodyweight for both sexes. 

Therefore, the oral LD50 in the rat (both sexes) is determined as higher than 3000 mg/kg bodyweight.

 

Acute inhalation toxicity

When male & female rats were exposed to an atmosphere of DEGDB (calculated to be 200 mg/L) over a four hour period and observed over 14 days, no deaths were seen. On this basis, DEGDB would not be considered a toxic material by the inhalation route of administration.

 

Acute dermal toxicity

Male & female rats were exposed to a 2000 mg/kg dose of DEGDB by the dermal route for 24 hours, then observed for 14 days following test material removal. No rats died during the observation period, and no clinical or pathological signs were observed. On the basis of these results, it was concluded that the acute lethal dermal dose (LD50) to rats of DEGDB was demonstrated to be greater than 2000 mg/kg bodyweight.

Justification for classification or non-classification

According to the criteria laid down in Council Directive 67/548/EEC (DSD) the test item DEGDB is considered not acutely toxic by the oral, dermal and inhalation routes and is not classified. Additionally, it is not classified under the CLP directive.