Registration Dossier

Administrative data

Description of key information

Acute oral toxicity : The oral LD50 in rats was determined to be 2885 mg/kg bw in a study conducted similarly to OECD guideline 401.
Acute inhalation toxicity: No mortality occurred when rats were exposed to air near-saturated with POPDA vapor for 8 hours.
Acute dermal toxicity: In a study conducted similarly to OECD guideline 402, the acute dermal LD50 was determined to be 2980 mg/kg bw in New Zealand White rabbits.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 885 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
740 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 980 mg/kg bw

Additional information

Acute toxicity studies of sufficient quality and conducted in methods comparable to OECD guidelines were available for oral, dermal, and inhalation routes of exposure to POPDA.

The acute oral study was conducted using methods comparable to OECD guideline 401. Groups of 5 male and 5 female rats received an oral dose of test substance by gavage at 2000, 2500, 3000 and 4000 mg/kg bw, and the acute oral LD50 was determined to be 2885 mg/kg bw (combined sexes). Lower LD50 values were found in other studies which were assigned either not reliable (Klimisch 3) or not assignable (Klimisch 4). In these older studies, the used methods were poorly described. Furthermore, no constant dosing volume was applied, which could be the cause of the higher mortality.

In the acute dermal study conducted using methods similar to OECD guideline 402, groups of 5 male and 5 female New Zealand White rabbits were exposed to the test substance for 24 hours occlusively at 500, 2000, 3200 and 4000 mg/kg bw. The acute dermal LD50 was determined to be 2980 mg/kg bw (combined sexes). Lower LD50 values were found in other studies which were assigned either not reliable (Klimisch 3) or not assignable (Klimisch 4). In these older studies, the used methods were poorly described. Furthermore, no constant dosing volume was applied, which could be the cause of the higher mortality.

In the acute inhalation study conducted using methods similar to OECD guideline 403, groups of rats were exposed to air nearly saturated with POPDA vapor for 8 hours. The nominal concentration was calculated to be 0.74 mg/L (740 mg/m3). No mortality occurred during the 14 day observation period.


Justification for selection of acute toxicity – oral endpoint
Only one reliable study available
Justification for selection of acute toxicity – dermal endpoint
Only one reliable study available
Justification for selection of acute toxicity – inhalation endpoint
Only one reliable study available

Justification for classification or non-classification

The oral LD50 of 2885 mg/kg falls outside the hazard categories for acute oral toxicity, and therefore no classification is warranted for the oral route.

The dermal LD50 of 2980 mg/kg falls outside the hazard categories for acute dermal toxicity, and therefore no classification is warranted for the dermal route.

The inhalatory LC50 is set at greater than 740 mg/m³, as it is based on one dose tested only. Therefore, no conclusion can be made on the classification.