N-(2-nitrophenyl)phosphoric triamide

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

no further testing for developmental toxicity is necessary because the substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment and the classification and labelling of the substance

Justification for type of information:

Clear indication for adverse effect on fertility and development of F1 pups was observed in the screening study according to OECD 421.
Treatment of the parental animals with the high dose of 450 mg N-(2-nitrophenyl)phosphoric triamide/kg b.w./day resulted in a severely increased number of deceased pups during the first 4 lactation days and a reduced mean and total body weight of the male and female pups.
According to the classification criteria there was “clear evidence” for developmental toxicity. Since no serious deficiencies in study design can be located classification of N-(2-nitrophenyl)phosphoric triamide into category 1B is most appropriate.
Therefore no further testing is required.

Materials and methods

Test animals

Species:

rat