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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
fish early-life stage toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Dissolved concentrations from a 28d-T/Dp test at a loading of 1 mg/L were the starting point for the assessment of long-term environmental effects (for daphnia and fish) of a sparingly soluble substance such as Fe3P. As explained in section 2 of this document, a ‘classic’ assessment approach is not possible for this substance due to several reasons:
• the complexity of P-speciation
• the low levels of dissolved P make the identification/quantification of all individual species impossible
• the lack of relevant ERVs for all individual P-species forms
• it is technically not feasible to make an equivalent solution in standard test medium with regard to P-speciation by using soluble salts

The only remaining option for the required assessment is to conduct the tests directly in T/D-medium. This approach was successfully applied for acute toxicity testing (7-dT/Dp medium with loadings of 10 and 100 mg/L), but conducting long-term tests would need large amounts of continuously generated T/Dp medium, and the production set-up as well as the analytical monitoring of all test solutions would come at an excessive cost. Such cost could only be justified if there are reasonable indications that long-term toxicity is likely to occur.

All Fe3P data that are currently available, however, demonstrate that this is not the case:
• No acute toxicity of Fe3P was noted for the fish P. promelas (96h-LC50 >100 mg/ Fe3P in TDp medium) and the green algae R. subcapitata (EC10 >100 mg/ Fe3P in T/Dp medium; algal growth stimulation compared to the control). It can thus be concluded that none of the released P-species (known and unknown forms) at a loading of 100 mg/L can cause an acute adverse effect, and dissolved levels are within the range of concentrations that are found in natural surface waters.
• Phosphine is a toxic P-compound that is formed upon dissolution of some P-compounds; the tests of phosphine-evolution in T/Dp medium at pH 6 showed that no phosphine could be detected after 7 days at a loading of 400 g/L (Klimmek and Schneider, 2021; study included in section 4.8 of the dossier). This exposure period is typically used for assessing acute toxicity, whereas 28 days is representative for long-term testing. This is a factor of four shorter, but at the same time an extreme high loading was assessed, i.e. 400 g/L, or 4.0 x 10^8 times higher than the reference loading of 1 mg/L for assessing long-term effects.

The loading of Fe3P in this phosphine evolution test is half a billion times higher than what needs to be considered for long-term assessment purposes; since no phosphine is detected in this test design after 7 days, it was be concluded that this P-species form is not formed when Fe3P dissolves in water under environmentally relevant conditions. Read-across to non-hazardous P-compounds is justified and a long-term test with Fe3P can be waived on the basis that this is scientifically not necessary.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion