Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

96h LC50 > 100 mg/L
96h NOEC >= 100 mg/l

Key value for chemical safety assessment

Additional information

No data on the Short Term Toxicity to fish of the substance is available. The results from the structural analogue are used instead (for details see reporting Format as attached to section 13 in the IUCLID dossier).

Two data are available for this endpoint.

In the first study (Safepharm, 1992), the acute toxicity of the test substance Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate to Rainbow trout was determined in a 96-hour semi-static limit test according to the method C.1 of EEC Directive 84/449 (previous version of the EEC Directive 92/69), OECD Guideline No. 203 (1984) and GLP.

 The nominal test substance concentration tested was 100 mg/L. A control group was tested in parallel.

 At the start and the end of the test, the analytically determined concentrations of the test substance in the test media were between 89.5 and 96.2% of the nominal values. Thus, it was demonstrated that the test substance was stable during the test period, and the reported biological results are based on the nominal test substance concentrations.

 As no mortality was observed during the exposition period, the 96-hour LC50 of Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate was > 100 mg/L and the 96 -hour NOEC of Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate was >= 100 mg/L.

 Based on these results, Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate should not be considered as harmful to the aquatic organisms tested.

The second study available (Kurume Laboratory, 2000) is a preliminary test of a bioaccumulation study. The acute toxicity of the test substance Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate to Oryzias latipes was determined in a 96-hour semi-static test according to a Japanese Industrial Standard.

 The nominal test substance concentrations tested were 198, 296, 444, 667 and 1000 mg/L. A control group was tested in parallel.

 No analytical monitoring has been performed.

 At the test substance concentration of 1000 mg/L, 100% mortality was observed at 24 hours.

At the test substance concentration of 667 mg/L, 40% mortality was observed at 24 hours, 60% mortality was observed at 48, 72 and 96 hours

For the other test substance concentrations (i.e. 198, 296 and 444 mg/L) and control, no mortality has been observed.

The 96-hour LC50 of Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate was determined to be 623 mg/L.

 

As the first study (Safepharm, 1992) has been performed according to the OECD and EU guidelines, following the GLP, and that the validity criteria were fulfilled, this study is considered as reliable without restrictions. Moreover, among the two studies available, it gives the most conservative result, therefore is selected as key study.

The second study (Kurume Laboratory) is considered as reliable with restrictions because, even if the method is acceptable, some details on test method are lacking and no analytical monitoring has been performed. As the result obtained is consistent with the key study, it has been selected as supporting study.