Registration Dossier

Administrative data

Description of key information

In a series of LD50 studies reported by Smyth et al. (1962), the LD50 of DIDP in rats is above 62,080 mg/kg. In a 24-hour exposure dermal study (Hazleton Laboratories America, 1978) in rabbits (4 animals, sex not specified), a dose of 3,160 mg/kg was applied on abraded skin and remained in contact with the skin by means of a non-absorbent binding. There was no mortality during the 14-day test period. The dermal LD50 was therefore estimated to be greater than 3,160 mg/kg.  (Industrial Bio-Test Laboratories, 1975) was conducted in rats, mice and Guinea pigs (5 males and 5 females) at 0.13 mg/l (nominal concentration). DIDP was reported to have been administered as a vapor, but regarding the test conditions the substance was probably administered as an aerosol. No deaths occurred, no adverse reactions were noticed following the 14-day observation period, and there were no gross tissue changes attributable to effects of the test  The LC50 is >0.13 mg/l.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
62 080 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
130 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 160 mg/kg bw

Additional information

Most of the animal studies on acute toxicity were either not available in sufficient detail to be thoroughly reviewed, or they were performed prior to establishment of OECD or EU guidelines. However in view of the consistency of the results for all routes of exposure, it can be considered that DIDP has a low potential for acute toxicity via the oral, dermal and inhalation routes.

Justification for classification or non-classification