Registration Dossier

Administrative data

Description of key information

An oral toxicity test is available, which is conducted according to OECD 401. The study was conducted before GLP guidelines were in place.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 500 mg/kg bw
Quality of whole database:
The available oral toxicity test is conducted according to OECD 401. The study was conducted before GLP guidelines were in place. It is reliable without restrictions (score 1).

Additional information

Oral toxicity

In an oral toxicity test according to OECD 401, 5 male and 5 female rats were exposed to a single dose of TPAB at 1800, 2400 or 3200 mg/kg. No animals died in the group exposed to 2400 mg/kg bw, in the 1800 mg/kg bw group 3 animals (1 m/ 2 f) died and at 3200 mg/kg bw 6 rats died (3 m/ 3 f). Lethargic behaviour was noted for most of the exposed animals, also cases of diarrhea, bloody nose encrustation and occasional tremors were noted. No body weight effect was reported in the surviving animals. Macroscopic examination of surviving animals at the end of the study showed no test substance related gross abnormalities. Macroscopic examination of animals found dead revealed test substance related petechia or erosion of the gastro intestinal tract, followed by bloody content. Other gross internal findings were aqueous gastrointestinal content (possibly test substance; in the majority of animals), enlarged submaxillary lymphnode, yellowish discoloured stomach content, enlarged adrenals and renal hyperemia. Based on these data, the LD50 for oral toxicity in both males and females was found to be 3500 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
This data set is the only information available.

Justification for classification or non-classification

The LD50 for oral toxicity in both males and females was found to be 3500 mg/kg bw. Therefore this substance is not classified according to Regulation (EC) No. 1272/2008.