Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.

Data source

Materials and methods

Test animals


Results and discussion

Applicant's summary and conclusion