Registration Dossier

Administrative data

Description of key information

Acute toxicity after oral and dermal administration of triphenyl phosphate is very low. Acute oral administration in rats, mice, rabbits and guinea pigs produced LD50 values in a range of 3000 mg/kg body weight to above 20000 mg/kg body weight. After dermal application an LD50 >7900 mg/kg body weight was established in rabbits. No valid studies are available regarding inhalation exposure to TPP. A number of studies are available using other routes of exposure such as subcutaneous, intraperitoneal and intramuscular injections which confirm the low level acute toxicity of triphenyl phosphate.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
3 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
7 900 mg/kg bw

Additional information

Non-guideline toxicity studies were performed mainly in rats and hens, but mice, rabbits, cats and guinea pigs were also used. Nevertheless, the acute toxicity could be evaluated from the available evidence.

There are also a number of studies using subcutaneous, intraperitoneal and intramuscular injections. The studies considered valid confirm the low level of toxicity. These routes of administration are not considered relevant for triphenyl phosphate exposure in man and are therefore not included in the overall chemical assessment. The data available on toxicity via oral dermal routes is sufficient (rated 2) and is listed in table.

 Study Type  Species  Endpoint  Exposure  Result  Reference
 Acute oral  Rat  LD50  single; dose level 20000 mg/kg bw  >20000 mg/kg bw  Mackellar DG, 1976
 Acute oral  Rat  LD50  single; maximum dose level 15800 mg/kg bw  10800 mg/kg bw  Johannsen FR et al., 1977
Acute oral   Rat  LD50  single; dose levels 2500 - 5000 mg/kg bw  >5000 mg/kg bw  Ciba-Geigy, 1954
 Acute oral  Mouse  LD50  single; dose levels 2500 - 5000 mg/kg bw  >5000 mg/kg bw  Ciba-Geigy, 1954
 Acute oral  Guinea pig  LD0  single; dose levels 3000 -4000 mg/kg bw  >4000 mg/kg bw  Sutton WL et al., 1960
 Acute oral  Hen  Neurotoxicity  single; undiluted, dose level 1000 mg/kg bw  No signs of neurotoxicity; >1000 mg/kg bw  Hine CH et al., 1956
 Acute oral  Hen Neurotoxicity  single; dose level 500 mg/kg bw in arachis oil   No signs of neurotoxicity; >500 mg/kg bw  Aldridge WN et al., 1961
 Acute oral  Hen  Neurotoxicity  single; dose level 30g/kg in olive oil as gelatine capsules    No signs of neurotoxicity; >10000 mg/kg bw Henschler D et al., 1958 
 Acute oral  Hen  LD0  single; dose level 5000 mg/kg bw in gelatine capsules  >5000 mg/kg bw   Johannsen FR et al., 1977
 Acute oral  Hen  NOEL  single; dose level 2, 3, 5, 8, 12.5 g/kg in arachis oil  > 12500 mg/kg bw   Ciba-Geigy, 1980
 Acute oral  Hen  NOEL  single; dose level 12000 mg/kg bw  > 12000 mg/kg bw   Ciba-Geigy, 1981
 Dermal  Rabbit  LD50  single; dose level 10000 mg/kg bw  >10000 mg/kg bw   Mackellar DG, 1976
 Dermal  Rabbit  LD50  sinlge; dose level 7900 mg/kg bw  >7900 mg/kg bw    Johannsen FR et al., 1977

Justification for classification or non-classification

The level of acute toxicity after oral and dermal administration is low and the LD50 values suggest that no classification is required for these routes of exposure.