Registration Dossier

Administrative data

Description of key information

The toxicity of the substance is low after oral or dermal exposure, or exposure via inhalation. 
oral LD50 > 2000 mg/kg
inhalative LC50 > 1.8 mg/L (strucutrally related phthalate)
dermal LD50 > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw

Additional information

No mortality was observed in various studies with the submission substance as well as other structurally related materials up to very high doses. Therefore the toxicity of the substance is low after oral or dermal exposure, or exposure via inhalation.

The LD50 of 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters was greater than 2000 mg/kg bodyweight.

The acute dermal toxicity has been investigated following administration of a single dose to the rat at a level of 2000 mg/kg. No mortality occurred, demonstrating the LD50 to be greater than 2000 mg/kg. In the rabbit, a LD50 in excess of 7940 mg/kg body weight for the structurally related substance Diundecylphthalate has been reported.

Six hours exposure to a saturated vapour concentration of 1.8 mg/L of the structurally related substance Diundecylphthalate, resulted in no mortality. The vapour concentration tested is considered to represent the highest achievable.


Justification for selection of acute toxicity – inhalation endpoint
The test substance has very low vapour pressure (ca. 0.001 mBar at 38°C), so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test needs to be performed. Data from a supporting study on a similar substance demonstrate the lack of toxicity after single exposure via inhalation.

Justification for classification or non-classification

Overall, the acute oral and dermal toxicity of the test substance is expected to be low and does not require classification according to

Regulation (EC) No 1272/2008.