Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Diisobutyl phthalate is not acutely toxic.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Additional information

In two separate studies, both done to pre-guideline methodologies, the oral LD50 of DIBP was found to be over 10 g per kilogram body weight, and between 16 and 28 g per kilogram bodyweight.

Dermal exposures also elicited minimal toxicity - with 10ml per kilogram body weight applied to the backs of guinea pigs with an occlusive dressing not giving rise to any toxicological effects or deaths.

Two reports of the determination of an LD50 in the male mouse via intraperitoneal injection reported values of approximately 4 g per kg bw.

There is no information on the inhalation hazard of DIBP - however phthalate esters generally are of extremely low toxicity by the inhalation route - as for all other routes. Consequently, this particular endpoint is waived on the basis that any potential exposures could not approach levels that are acutely toxic. Typical values cited in reviews for inhalation toxicity of phthalate esters are greater than 15 mg/l (DBP as cited in the official EU risk assessment - EU 2003)

Justification for classification or non-classification

The available data together with supporting information for other phthalate diesters indicates that DIBP does require classification for acute toxicity.