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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

There were no signs of systemic toxicity or reproductive or developmental effects at any dose level up to, and including, 1000 mg/kg/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

An enhanced combined repeat-dose and reproductive and developmental effects study was performed on triisodecyl phosphite (TDP), one of the constituents for commercial PDDP/DDPP and a structural analog to the other constituents.

This study was conducted in rats via oral gavage and included evaluations of systemic toxicity and neurotoxicity in both the F0 and F1 generations in addition to evaluations of reproductive performance and developmental effects. 

 

TDP administered by gavage once daily at 0, 50, 250 and 1000 mg/kg/day to parental F0 CD (SD) rats, 10/sex/group through prebreed, mating, gestation and F1 lactation resulted in essentially no treatment or dose related adult F0 parental toxicity at any dose at any time. Reproductive toxicity was not present in F0 males or females. There was also no F1offspring toxicity observed postnatally through the weanling necropsy. Therefore, the F0 male and female systemic no observable adverse effect level (NOAEL) was at or above 1000mg/kg/day for males and females. The NOAELs for F0 reproductive toxicity were observed at or above 1000 mg/kg/day for males and females. The NOAELs for F1 offspring toxicity during lactation were also at or above 1000 mg/kg/day for males and females.

Justification for classification or non-classification

There were no signs of systemic toxicity or reproductive or developmental effects at any dose level up to, and including, 1000 mg/kg/day.