Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The terrestrial ecosystem comprises of an above-ground community, a soil community and a groundwater community. According to REACH guidance it is so far not possible to carry out effect assessment for the groundwater community, since no toxicity tests/data exist for this compartment.

The bioavailability, and therefore the toxicity of a compound in soil, is dependent on soil characteristics, such as organic matter and clay content. Subsequently, to allow comparison of results from toxicity test carried out in different soils, test results have to be converted to a standard soil, which is defined as a soil with an organic matter content of 3.4%. The obtained NOECs could be normalised according to the formula:

NOEC (or EC) = NOEC (or EC) * [0.034 / fract. org. matter in experimental soil]

Since no PNECwater was determined, the equilibrium partition method, given in TGD, could not be used to estimate PNECsoil. There are several studies in which plants or soil organisms have been exposed to DEHP. These studies indicate that DEHP is not harmful to soil organisms (and plants). However, most of these studies were questionable due to irrelevant exposure situations. Only four studies exist with a relevant exposure situation that can be used for comparison with PECsoil. The four relevant studies represent three trophic levels. The lowest normalised unbounded NOEC from these studies was 130 mg/kg dwt (the highest tested concentration). If an assessment factor of 10 is applied on this NOEC, a PNEC of 13 mg/kg dwt is obtained. Since the PNEC is derived from a study where NOEC is the highest tested concentration, it can only be concluded that PNECsoil > 13 mg/kg dwt.

After examination of all available studies, only one relevant study on toxicity to birds is available.

In their study Wood and Bitman (1980) fed White Leghorn laying hens with either a standard laying mash control diet (C) or the control diet containing 1% DEHP (DEHP) or 1% DEHP and 5% tallow (DEHP-T) for 28 days. Endpoints recorded were the feed consumption, body weight, egg production and composition, yolk fat and total cholesterol and, liver composition, lipid and cholesterol content.

As DEHP induced a decreased in egg production (14%) and effects on lipid metabolism were found at the lowest test concentration, LOEC = 10000 ppm. As an effect level of 14% fulfill the prerequisite for dividing the LOEC by two, resulting in a NOEC of 5000 ppm. The feed in this study was a standard laying mash (consisting mainly of different meals). In TGD (Appendix VII) it is stated that the energy content of grain is higher than fish. This means that in order to obtain the same amount of energy more wet weight of fish must be consumed compared to grain. Therefore a correction factor of 3 may be applied for the difference in caloric content of the diet of laboratory animals and the diet of fish-eating birds or mammals”. Hence, the NOEC can be lowered with a factor 3 resulting in a NOEC of about 1700 mg/kg food.